id	sid	tid	token	lemma	pos
ihlr-18810	1	1	510(k	510(k	X
ihlr-18810	1	2	)	)	PUNCT
ihlr-18810	1	3	clearance	clearance	NOUN
ihlr-18810	1	4	:	:	PUNCT
ihlr-18810	1	5	opportunities	opportunity	NOUN
ihlr-18810	1	6	to	to	PART
ihlr-18810	1	7	incentivize	incentivize	VERB
ihlr-18810	1	8	medical	medical	ADJ
ihlr-18810	1	9	device	device	NOUN
ihlr-18810	1	10	safety	safety	NOUN
ihlr-18810	1	11	through	through	ADP
ihlr-18810	1	12	comparative	comparative	ADJ
ihlr-18810	1	13	effectiveness	effectiveness	NOUN
ihlr-18810	1	14	research	research	NOUN
ihlr-18810	1	15	510(k	510(k	NUM
ihlr-18810	1	16	)	)	PUNCT
ihlr-18810	1	17	clearance	clearance	NOUN
ihlr-18810	1	18	:	:	PUNCT
ihlr-18810	1	19	opportunities	opportunity	NOUN
ihlr-18810	1	20	to	to	PART
ihlr-18810	1	21	incentivize	incentivize	VERB
ihlr-18810	1	22	medical	medical	ADJ
ihlr-18810	1	23	device	device	NOUN
ihlr-18810	1	24	safety	safety	NOUN
ihlr-18810	1	25	through	through	ADP
ihlr-18810	1	26	comparative	comparative	ADJ
ihlr-18810	1	27	effectiveness	effectiveness	NOUN
ihlr-18810	1	28	research	research	PROPN
ihlr-18810	1	29	amanda	amanda	PROPN
ihlr-18810	1	30	swanson	swanson	PROPN
ihlr-18810	1	31	*	*	PROPN
ihlr-18810	1	32	abstract	abstract	PROPN
ihlr-18810	1	33	.........................................	.........................................	PUNCT
ihlr-18810	1	34	117	117	NUM
ihlr-18810	1	35	i.	i.	NOUN
ihlr-18810	1	36	introduction	introduction	NOUN
ihlr-18810	1	37	...................................	...................................	PUNCT
ihlr-18810	2	1	118	118	NUM
ihlr-18810	2	2	ii	ii	NOUN
ihlr-18810	2	3	.	.	PUNCT
ihlr-18810	3	1	federal	federal	ADJ
ihlr-18810	3	2	regulation	regulation	NOUN
ihlr-18810	3	3	of	of	ADP
ihlr-18810	3	4	medical	medical	ADJ
ihlr-18810	3	5	device	device	NOUN
ihlr-18810	3	6	safety	safety	NOUN
ihlr-18810	3	7	and	and	CCONJ
ihlr-18810	3	8	efficacy	efficacy	NOUN
ihlr-18810	3	9	..................................	..................................	PUNCT
ihlr-18810	3	10	......	......	PUNCT
ihlr-18810	4	1	120	120	NUM
ihlr-18810	4	2	a.	a.	NOUN
ihlr-18810	4	3	history	history	NOUN
ihlr-18810	4	4	.............................	.............................	PUNCT
ihlr-18810	4	5	......	......	PUNCT
ihlr-18810	5	1	120	120	NUM
ihlr-18810	5	2	b.	b.	PROPN
ihlr-18810	5	3	fda	fda	PROPN
ihlr-18810	5	4	regulation	regulation	PROPN
ihlr-18810	5	5	.......................	.......................	PUNCT
ihlr-18810	5	6	.....	.....	PUNCT
ihlr-18810	6	1	129	129	NUM
ihlr-18810	6	2	1	1	NUM
ihlr-18810	6	3	.	.	PUNCT
ihlr-18810	6	4	rulemaking	rulemaking	NOUN
ihlr-18810	6	5	and	and	CCONJ
ihlr-18810	6	6	guidance	guidance	NOUN
ihlr-18810	6	7	.	.	PUNCT
ihlr-18810	6	8	........	........	PUNCT
ihlr-18810	7	1	..........	..........	PUNCT
ihlr-18810	8	1	129	129	NUM
ihlr-18810	8	2	2	2	NUM
ihlr-18810	8	3	.	.	X
ihlr-18810	8	4	reporting	reporting	NOUN
ihlr-18810	8	5	and	and	CCONJ
ihlr-18810	8	6	postmarket	postmarket	ADJ
ihlr-18810	8	7	surveillance	surveillance	NOUN
ihlr-18810	8	8	...	...	PUNCT
ihlr-18810	9	1	.....	.....	PUNCT
ihlr-18810	10	1	134	134	NUM
ihlr-18810	10	2	3	3	NUM
ihlr-18810	10	3	.	.	PUNCT
ihlr-18810	10	4	enforcement	enforcement	NOUN
ihlr-18810	10	5	powers	power	NOUN
ihlr-18810	10	6	....	....	PUNCT
ihlr-18810	10	7	...................	...................	PUNCT
ihlr-18810	11	1	142	142	NUM
ihlr-18810	11	2	a.	a.	NOUN
ihlr-18810	11	3	administrative	administrative	PROPN
ihlr-18810	11	4	..............................	..............................	PUNCT
ihlr-18810	11	5	142	142	NUM
ihlr-18810	11	6	b.	b.	PROPN
ihlr-18810	11	7	judicial	judicial	PROPN
ihlr-18810	11	8	................................	................................	PUNCT
ihlr-18810	11	9	145	145	NUM
ihlr-18810	11	10	c	c	NOUN
ihlr-18810	11	11	wh	wh	AUX
ihlr-18810	11	12	en	en	X
ihlr-18810	11	13	the	the	DET
ihlr-18810	11	14	regulatory	regulatory	ADJ
ihlr-18810	11	15	process	process	NOUN
ihlr-18810	11	16	fails	fail	VERB
ihlr-18810	11	17	:	:	PUNCT
ihlr-18810	11	18	the	the	DET
ihlr-18810	11	19	tort	tort	NOUN
ihlr-18810	11	20	system	system	NOUN
ihlr-18810	11	21	...................................	...................................	PUNCT
ihlr-18810	11	22	147	147	NUM
ihlr-18810	11	23	iii	iii	NOUN
ihlr-18810	11	24	.	.	PUNCT
ihlr-18810	11	25	proposals	proposal	NOUN
ihlr-18810	11	26	to	to	PART
ihlr-18810	11	27	fix	fix	VERB
ihlr-18810	11	28	the	the	DET
ihlr-18810	11	29	flaws	flaw	NOUN
ihlr-18810	11	30	in	in	ADP
ihlr-18810	11	31	the	the	DET
ihlr-18810	11	32	system	system	NOUN
ihlr-18810	11	33	.............	.............	PUNCT
ihlr-18810	11	34	152	152	NUM
ihlr-18810	11	35	a.	a.	NOUN
ihlr-18810	11	36	institute	institute	NOUN
ihlr-18810	11	37	of	of	ADP
ihlr-18810	11	38	medicine	medicine	NOUN
ihlr-18810	11	39	:	:	PUNCT
ihlr-18810	11	40	a	a	DET
ihlr-18810	11	41	new	new	ADJ
ihlr-18810	11	42	regulatory	regulatory	ADJ
ihlr-18810	11	43	system	system	NOUN
ihlr-18810	11	44	for	for	ADP
ihlr-18810	11	45	510(k	510(k	PROPN
ihlr-18810	11	46	)	)	PUNCT
ihlr-18810	11	47	devices	device	NOUN
ihlr-18810	11	48	........................	........................	PUNCT
ihlr-18810	12	1	.....	.....	PUNCT
ihlr-18810	13	1	152	152	NUM
ihlr-18810	13	2	b.	b.	NOUN
ihlr-18810	13	3	use	use	NOUN
ihlr-18810	13	4	of	of	ADP
ihlr-18810	13	5	comparative	comparative	ADJ
ihlr-18810	13	6	effectiveness	effectiveness	NOUN
ihlr-18810	13	7	research	research	NOUN
ihlr-18810	13	8	by	by	ADP
ihlr-18810	13	9	the	the	DET
ihlr-18810	13	10	government	government	NOUN
ihlr-18810	13	11	as	as	ADP
ihlr-18810	13	12	payer	payer	NOUN
ihlr-18810	13	13	...	...	PUNCT
ihlr-18810	13	14	....................	....................	PUNCT
ihlr-18810	14	1	156	156	NUM
ihlr-18810	14	2	iv	iv	NOUN
ihlr-18810	14	3	.	.	PUNCT
ihlr-18810	14	4	conclusion	conclusion	NOUN
ihlr-18810	14	5	...............................	...............................	PUNCT
ihlr-18810	15	1	.....	.....	PUNCT
ihlr-18810	16	1	172	172	NUM
ihlr-18810	17	1	abstract	abstract	ADJ
ihlr-18810	17	2	the	the	DET
ihlr-18810	17	3	food	food	NOUN
ihlr-18810	17	4	and	and	CCONJ
ihlr-18810	17	5	drug	drug	PROPN
ihlr-18810	17	6	administration	administration	NOUN
ihlr-18810	17	7	's	's	PART
ihlr-18810	17	8	510(k	510(k	PROPN
ihlr-18810	17	9	)	)	PUNCT
ihlr-18810	17	10	clearance	clearance	NOUN
ihlr-18810	17	11	process	process	NOUN
ihlr-18810	17	12	,	,	PUNCT
ihlr-18810	17	13	which	which	PRON
ihlr-18810	17	14	clears	clear	VERB
ihlr-18810	17	15	medical	medical	ADJ
ihlr-18810	17	16	devices	device	NOUN
ihlr-18810	17	17	for	for	ADP
ihlr-18810	17	18	marketing	marketing	NOUN
ihlr-18810	17	19	based	base	VERB
ihlr-18810	17	20	on	on	ADP
ihlr-18810	17	21	their	their	PRON
ihlr-18810	17	22	similarity	similarity	NOUN
ihlr-18810	17	23	to	to	ADP
ihlr-18810	17	24	devices	device	NOUN
ihlr-18810	17	25	already	already	ADV
ihlr-18810	17	26	available	available	ADJ
ihlr-18810	17	27	on	on	ADP
ihlr-18810	17	28	the	the	DET
ihlr-18810	17	29	market	market	NOUN
ihlr-18810	17	30	,	,	PUNCT
ihlr-18810	17	31	has	have	AUX
ihlr-18810	17	32	remained	remain	VERB
ihlr-18810	17	33	almost	almost	ADV
ihlr-18810	17	34	entirely	entirely	ADV
ihlr-18810	17	35	unchanged	unchanged	ADJ
ihlr-18810	17	36	since	since	SCONJ
ihlr-18810	17	37	its	its	PRON
ihlr-18810	17	38	creation	creation	NOUN
ihlr-18810	17	39	in	in	ADP
ihlr-18810	17	40	1976	1976	NUM
ihlr-18810	17	41	.	.	PUNCT
ihlr-18810	18	1	thirty	thirty	NUM
ihlr-18810	18	2	-	-	PUNCT
ihlr-18810	18	3	five	five	NUM
ihlr-18810	18	4	years	year	NOUN
ihlr-18810	18	5	later	later	ADV
ihlr-18810	18	6	,	,	PUNCT
ihlr-18810	18	7	the	the	DET
ihlr-18810	18	8	institute	institute	NOUN
ihlr-18810	18	9	of	of	ADP
ihlr-18810	18	10	*	*	PROPN
ihlr-18810	18	11	amanda	amanda	PROPN
ihlr-18810	18	12	swanson	swanson	PROPN
ihlr-18810	18	13	is	be	AUX
ihlr-18810	18	14	an	an	DET
ihlr-18810	18	15	illinois	illinois	PROPN
ihlr-18810	18	16	licensed	licensed	ADJ
ihlr-18810	18	17	attorney	attorney	NOUN
ihlr-18810	18	18	and	and	CCONJ
ihlr-18810	18	19	received	receive	VERB
ihlr-18810	18	20	her	she	PRON
ihlr-18810	18	21	ll.m	ll.m	NOUN
ihlr-18810	18	22	.	.	PUNCT
ihlr-18810	19	1	in	in	ADP
ihlr-18810	19	2	health	health	NOUN
ihlr-18810	19	3	law	law	NOUN
ihlr-18810	19	4	and	and	CCONJ
ihlr-18810	19	5	j.d	j.d	PROPN
ihlr-18810	19	6	.	.	PROPN
ihlr-18810	19	7	from	from	ADP
ihlr-18810	19	8	loyola	loyola	PROPN
ihlr-18810	19	9	university	university	NOUN
ihlr-18810	19	10	chicago	chicago	PROPN
ihlr-18810	19	11	school	school	NOUN
ihlr-18810	19	12	of	of	ADP
ihlr-18810	19	13	law	law	NOUN
ihlr-18810	19	14	.	.	PUNCT
ihlr-18810	20	1	she	she	PRON
ihlr-18810	20	2	currently	currently	ADV
ihlr-18810	20	3	works	work	VERB
ihlr-18810	20	4	for	for	ADP
ihlr-18810	20	5	the	the	DET
ihlr-18810	20	6	city	city	NOUN
ihlr-18810	20	7	of	of	ADP
ihlr-18810	20	8	chicago	chicago	PROPN
ihlr-18810	20	9	department	department	PROPN
ihlr-18810	20	10	of	of	ADP
ihlr-18810	20	11	law	law	NOUN
ihlr-18810	20	12	,	,	PUNCT
ihlr-18810	20	13	and	and	CCONJ
ihlr-18810	20	14	can	can	AUX
ihlr-18810	20	15	be	be	AUX
ihlr-18810	20	16	reached	reach	VERB
ihlr-18810	20	17	at	at	ADP
ihlr-18810	20	18	aeswans@gmail.com	aeswans@gmail.com	PROPN
ihlr-18810	20	19	.	.	PUNCT
ihlr-18810	21	1	indiana	indiana	PROPN
ihlr-18810	21	2	health	health	PROPN
ihlr-18810	21	3	law	law	PROPN
ihlr-18810	21	4	review	review	NOUN
ihlr-18810	21	5	medicine	medicine	NOUN
ihlr-18810	21	6	was	be	AUX
ihlr-18810	21	7	charged	charge	VERB
ihlr-18810	21	8	with	with	ADP
ihlr-18810	21	9	evaluating	evaluate	VERB
ihlr-18810	21	10	this	this	DET
ihlr-18810	21	11	process	process	NOUN
ihlr-18810	21	12	,	,	PUNCT
ihlr-18810	21	13	and	and	CCONJ
ihlr-18810	21	14	concluded	conclude	VERB
ihlr-18810	21	15	that	that	SCONJ
ihlr-18810	21	16	it	it	PRON
ihlr-18810	21	17	does	do	AUX
ihlr-18810	21	18	not	not	PART
ihlr-18810	21	19	sufficiently	sufficiently	ADV
ihlr-18810	21	20	protect	protect	VERB
ihlr-18810	21	21	patients	patient	NOUN
ihlr-18810	21	22	from	from	ADP
ihlr-18810	21	23	unsafe	unsafe	ADJ
ihlr-18810	21	24	medical	medical	ADJ
ihlr-18810	21	25	devices	device	NOUN
ihlr-18810	21	26	.	.	PUNCT
ihlr-18810	22	1	although	although	SCONJ
ihlr-18810	22	2	the	the	DET
ihlr-18810	22	3	iom	iom	PROPN
ihlr-18810	22	4	proposed	propose	VERB
ihlr-18810	22	5	creating	create	VERB
ihlr-18810	22	6	a	a	DET
ihlr-18810	22	7	new	new	ADJ
ihlr-18810	22	8	regulatory	regulatory	ADJ
ihlr-18810	22	9	framework	framework	NOUN
ihlr-18810	22	10	utilizing	utilize	VERB
ihlr-18810	22	11	more	more	ADJ
ihlr-18810	22	12	premarket	premarket	NOUN
ihlr-18810	22	13	and	and	CCONJ
ihlr-18810	22	14	postmarket	postmarket	ADJ
ihlr-18810	22	15	evaluation	evaluation	NOUN
ihlr-18810	22	16	of	of	ADP
ihlr-18810	22	17	scientific	scientific	ADJ
ihlr-18810	22	18	evidence	evidence	NOUN
ihlr-18810	22	19	of	of	ADP
ihlr-18810	22	20	safety	safety	NOUN
ihlr-18810	22	21	and	and	CCONJ
ihlr-18810	22	22	effectiveness	effectiveness	NOUN
ihlr-18810	22	23	,	,	PUNCT
ihlr-18810	22	24	the	the	DET
ihlr-18810	22	25	feasibility	feasibility	NOUN
ihlr-18810	22	26	of	of	ADP
ihlr-18810	22	27	this	this	PRON
ihlr-18810	22	28	is	be	AUX
ihlr-18810	22	29	limited	limit	VERB
ihlr-18810	22	30	by	by	ADP
ihlr-18810	22	31	the	the	DET
ihlr-18810	22	32	fda	fda	PROPN
ihlr-18810	22	33	's	's	PART
ihlr-18810	22	34	resource	resource	NOUN
ihlr-18810	22	35	constraints	constraint	NOUN
ihlr-18810	22	36	.	.	PUNCT
ihlr-18810	23	1	instead	instead	ADV
ihlr-18810	23	2	,	,	PUNCT
ihlr-18810	23	3	this	this	DET
ihlr-18810	23	4	article	article	NOUN
ihlr-18810	23	5	proposes	propose	VERB
ihlr-18810	23	6	that	that	SCONJ
ihlr-18810	23	7	the	the	DET
ihlr-18810	23	8	best	good	ADJ
ihlr-18810	23	9	solution	solution	NOUN
ihlr-18810	23	10	is	be	AUX
ihlr-18810	23	11	for	for	ADP
ihlr-18810	23	12	the	the	DET
ihlr-18810	23	13	federal	federal	ADJ
ihlr-18810	23	14	government	government	NOUN
ihlr-18810	23	15	,	,	PUNCT
ihlr-18810	23	16	in	in	ADP
ihlr-18810	23	17	its	its	PRON
ihlr-18810	23	18	capacity	capacity	NOUN
ihlr-18810	23	19	as	as	ADP
ihlr-18810	23	20	payer	payer	NOUN
ihlr-18810	23	21	,	,	PUNCT
ihlr-18810	23	22	to	to	PART
ihlr-18810	23	23	use	use	VERB
ihlr-18810	23	24	comparative	comparative	ADJ
ihlr-18810	23	25	effectiveness	effectiveness	NOUN
ihlr-18810	23	26	research	research	NOUN
ihlr-18810	23	27	in	in	ADP
ihlr-18810	23	28	its	its	PRON
ihlr-18810	23	29	coverage	coverage	NOUN
ihlr-18810	23	30	determinations	determination	NOUN
ihlr-18810	23	31	.	.	PUNCT
ihlr-18810	24	1	this	this	PRON
ihlr-18810	24	2	would	would	AUX
ihlr-18810	24	3	maintain	maintain	VERB
ihlr-18810	24	4	the	the	DET
ihlr-18810	24	5	efficiency	efficiency	NOUN
ihlr-18810	24	6	of	of	ADP
ihlr-18810	24	7	the	the	DET
ihlr-18810	24	8	510(k	510(k	PROPN
ihlr-18810	24	9	)	)	PUNCT
ihlr-18810	24	10	clearance	clearance	NOUN
ihlr-18810	24	11	process	process	NOUN
ihlr-18810	24	12	without	without	ADP
ihlr-18810	24	13	sacrificing	sacrifice	VERB
ihlr-18810	24	14	patient	patient	ADJ
ihlr-18810	24	15	safety	safety	NOUN
ihlr-18810	24	16	,	,	PUNCT
ihlr-18810	24	17	while	while	SCONJ
ihlr-18810	24	18	also	also	ADV
ihlr-18810	24	19	shifting	shift	VERB
ihlr-18810	24	20	the	the	DET
ihlr-18810	24	21	responsibility	responsibility	NOUN
ihlr-18810	24	22	for	for	ADP
ihlr-18810	24	23	increased	increase	VERB
ihlr-18810	24	24	surveillance	surveillance	NOUN
ihlr-18810	24	25	of	of	ADP
ihlr-18810	24	26	510(k	510(k	PROPN
ihlr-18810	24	27	)	)	PUNCT
ihlr-18810	24	28	devices	device	NOUN
ihlr-18810	24	29	from	from	ADP
ihlr-18810	24	30	the	the	DET
ihlr-18810	24	31	fda	fda	PROPN
ihlr-18810	24	32	to	to	ADP
ihlr-18810	24	33	other	other	ADJ
ihlr-18810	24	34	agencies	agency	NOUN
ihlr-18810	24	35	,	,	PUNCT
ihlr-18810	24	36	fostering	foster	VERB
ihlr-18810	24	37	innovation	innovation	NOUN
ihlr-18810	24	38	and	and	CCONJ
ihlr-18810	24	39	keeping	keep	VERB
ihlr-18810	24	40	the	the	DET
ihlr-18810	24	41	u.s	u.s	PROPN
ihlr-18810	24	42	.	.	PROPN
ihlr-18810	24	43	a	a	DET
ihlr-18810	24	44	competitive	competitive	ADJ
ihlr-18810	24	45	market	market	NOUN
ihlr-18810	24	46	in	in	ADP
ihlr-18810	24	47	the	the	DET
ihlr-18810	24	48	medical	medical	ADJ
ihlr-18810	24	49	device	device	NOUN
ihlr-18810	24	50	industry	industry	NOUN
ihlr-18810	24	51	.	.	PUNCT
ihlr-18810	25	1	i.	i.	PROPN
ihlr-18810	25	2	introduction	introduction	NOUN
ihlr-18810	25	3	after	after	ADP
ihlr-18810	25	4	a	a	DET
ihlr-18810	25	5	string	string	NOUN
ihlr-18810	25	6	of	of	ADP
ihlr-18810	25	7	adverse	adverse	ADJ
ihlr-18810	25	8	events	event	NOUN
ihlr-18810	25	9	resulting	result	VERB
ihlr-18810	25	10	from	from	ADP
ihlr-18810	25	11	the	the	DET
ihlr-18810	25	12	use	use	NOUN
ihlr-18810	25	13	of	of	ADP
ihlr-18810	25	14	faulty	faulty	ADJ
ihlr-18810	25	15	heart	heart	NOUN
ihlr-18810	25	16	-	-	PUNCT
ihlr-18810	25	17	defibrillator	defibrillator	NOUN
ihlr-18810	25	18	wires	wire	NOUN
ihlr-18810	25	19	,	,	PUNCT
ihlr-18810	25	20	'	'	PUNCT
ihlr-18810	25	21	three	three	NUM
ihlr-18810	25	22	senators	senator	NOUN
ihlr-18810	25	23	,	,	PUNCT
ihlr-18810	25	24	on	on	ADP
ihlr-18810	25	25	march	march	PROPN
ihlr-18810	25	26	15	15	NUM
ihlr-18810	25	27	,	,	PUNCT
ihlr-18810	25	28	2012	2012	NUM
ihlr-18810	25	29	,	,	PUNCT
ihlr-18810	25	30	introduced	introduce	VERB
ihlr-18810	25	31	a	a	DET
ihlr-18810	25	32	bill	bill	NOUN
ihlr-18810	25	33	in	in	ADP
ihlr-18810	25	34	congress	congress	PROPN
ihlr-18810	25	35	that	that	PRON
ihlr-18810	25	36	aims	aim	VERB
ihlr-18810	25	37	to	to	PART
ihlr-18810	25	38	improve	improve	VERB
ihlr-18810	25	39	the	the	DET
ihlr-18810	25	40	food	food	NOUN
ihlr-18810	25	41	and	and	CCONJ
ihlr-18810	25	42	drug	drug	PROPN
ihlr-18810	25	43	administration	administration	NOUN
ihlr-18810	25	44	's	's	PART
ihlr-18810	25	45	(	(	PUNCT
ihlr-18810	25	46	fda	fda	PROPN
ihlr-18810	25	47	)	)	PUNCT
ihlr-18810	25	48	oversight	oversight	NOUN
ihlr-18810	25	49	of	of	ADP
ihlr-18810	25	50	medical	medical	ADJ
ihlr-18810	25	51	devices	device	NOUN
ihlr-18810	25	52	,	,	PUNCT
ihlr-18810	25	53	entitled	entitle	VERB
ihlr-18810	25	54	the	the	DET
ihlr-18810	25	55	ensuring	ensure	VERB
ihlr-18810	25	56	safe	safe	ADJ
ihlr-18810	25	57	medical	medical	ADJ
ihlr-18810	25	58	devices	device	NOUN
ihlr-18810	25	59	for	for	ADP
ihlr-18810	25	60	patients	patient	NOUN
ihlr-18810	25	61	act	act	VERB
ihlr-18810	25	62	.	.	PUNCT
ihlr-18810	26	1	2	2	NUM
ihlr-18810	26	2	this	this	DET
ihlr-18810	26	3	bill	bill	NOUN
ihlr-18810	26	4	intends	intend	VERB
ihlr-18810	26	5	to	to	PART
ihlr-18810	26	6	accomplish	accomplish	VERB
ihlr-18810	26	7	this	this	PRON
ihlr-18810	26	8	through	through	ADP
ihlr-18810	26	9	increasing	increase	VERB
ihlr-18810	26	10	postmarket	postmarket	ADJ
ihlr-18810	26	11	surveillance	surveillance	NOUN
ihlr-18810	26	12	and	and	CCONJ
ihlr-18810	26	13	risk	risk	NOUN
ihlr-18810	26	14	identification	identification	NOUN
ihlr-18810	26	15	of	of	ADP
ihlr-18810	26	16	medical	medical	ADJ
ihlr-18810	26	17	devices	device	NOUN
ihlr-18810	26	18	,	,	PUNCT
ihlr-18810	26	19	and	and	CCONJ
ihlr-18810	26	20	also	also	ADV
ihlr-18810	26	21	creating	create	VERB
ihlr-18810	26	22	a	a	DET
ihlr-18810	26	23	unique	unique	ADJ
ihlr-18810	26	24	device	device	NOUN
ihlr-18810	26	25	identification	identification	NOUN
ihlr-18810	26	26	system	system	NOUN
ihlr-18810	26	27	,	,	PUNCT
ihlr-18810	26	28	which	which	PRON
ihlr-18810	26	29	would	would	AUX
ihlr-18810	26	30	require	require	VERB
ihlr-18810	26	31	implantable	implantable	ADJ
ihlr-18810	26	32	devices	device	NOUN
ihlr-18810	26	33	to	to	PART
ihlr-18810	26	34	carry	carry	VERB
ihlr-18810	26	35	a	a	DET
ihlr-18810	26	36	unique	unique	ADJ
ihlr-18810	26	37	number	number	NOUN
ihlr-18810	26	38	that	that	PRON
ihlr-18810	26	39	could	could	AUX
ihlr-18810	26	40	be	be	AUX
ihlr-18810	26	41	used	use	VERB
ihlr-18810	26	42	to	to	PART
ihlr-18810	26	43	track	track	VERB
ihlr-18810	26	44	the	the	DET
ihlr-18810	26	45	device	device	NOUN
ihlr-18810	26	46	through	through	ADP
ihlr-18810	26	47	the	the	DET
ihlr-18810	26	48	distribution	distribution	NOUN
ihlr-18810	26	49	chain.3	chain.3	NOUN
ihlr-18810	26	50	the	the	DET
ihlr-18810	26	51	goal	goal	NOUN
ihlr-18810	26	52	is	be	AUX
ihlr-18810	26	53	to	to	PART
ihlr-18810	26	54	protect	protect	VERB
ihlr-18810	26	55	patients	patient	NOUN
ihlr-18810	26	56	and	and	CCONJ
ihlr-18810	26	57	ensure	ensure	VERB
ihlr-18810	26	58	that	that	SCONJ
ihlr-18810	26	59	unsafe	unsafe	ADJ
ihlr-18810	26	60	1	1	NUM
ihlr-18810	26	61	see	see	VERB
ihlr-18810	26	62	thomas	thomas	PROPN
ihlr-18810	26	63	burton	burton	PROPN
ihlr-18810	26	64	,	,	PUNCT
ihlr-18810	26	65	fda	fda	PROPN
ihlr-18810	26	66	in	in	ADP
ihlr-18810	26	67	hot	hot	ADJ
ihlr-18810	26	68	seat	seat	NOUN
ihlr-18810	26	69	on	on	ADP
ihlr-18810	26	70	safety-	safety-	NOUN
ihlr-18810	26	71	*	*	NOUN
ihlr-18810	26	72	doctors	doctor	NOUN
ihlr-18810	26	73	want	want	VERB
ihlr-18810	26	74	agency	agency	NOUN
ihlr-18810	26	75	to	to	ADP
ihlr-18810	26	76	better	well	ADJ
ihlr-18810	26	77	gauge	gauge	VERB
ihlr-18810	26	78	risks	risk	NOUN
ihlr-18810	26	79	of	of	ADP
ihlr-18810	26	80	heart	heart	NOUN
ihlr-18810	26	81	devices	device	NOUN
ihlr-18810	26	82	,	,	PUNCT
ihlr-18810	26	83	wall	wall	PROPN
ihlr-18810	26	84	st	st	PROPN
ihlr-18810	26	85	.	.	PROPN
ihlr-18810	26	86	j.	j.	PROPN
ihlr-18810	26	87	,	,	PUNCT
ihlr-18810	26	88	apr	apr	PROPN
ihlr-18810	26	89	.	.	PROPN
ihlr-18810	26	90	9	9	NUM
ihlr-18810	26	91	,	,	PUNCT
ihlr-18810	26	92	2012	2012	NUM
ihlr-18810	26	93	,	,	PUNCT
ihlr-18810	26	94	http://online.wsj.com/article/sb10001424052702303772904577333	http://online.wsj.com/article/sb10001424052702303772904577333	PROPN
ihlr-18810	26	95	941715666550.html	941715666550.html	PROPN
ihlr-18810	26	96	(	(	PUNCT
ihlr-18810	26	97	last	last	ADV
ihlr-18810	26	98	visited	visit	VERB
ihlr-18810	26	99	nov	nov	PROPN
ihlr-18810	26	100	.	.	PROPN
ihlr-18810	26	101	25	25	NUM
ihlr-18810	26	102	,	,	PUNCT
ihlr-18810	26	103	2012	2012	NUM
ihlr-18810	26	104	)	)	PUNCT
ihlr-18810	26	105	.	.	PUNCT
ihlr-18810	27	1	2	2	NUM
ihlr-18810	27	2	ensuring	ensure	VERB
ihlr-18810	27	3	safe	safe	ADJ
ihlr-18810	27	4	medical	medical	ADJ
ihlr-18810	27	5	devices	device	NOUN
ihlr-18810	27	6	for	for	ADP
ihlr-18810	27	7	patients	patient	NOUN
ihlr-18810	27	8	act	act	PROPN
ihlr-18810	27	9	,	,	PUNCT
ihlr-18810	27	10	s.	s.	PROPN
ihlr-18810	27	11	2193	2193	NUM
ihlr-18810	27	12	,	,	PUNCT
ihlr-18810	27	13	112th	112th	PROPN
ihlr-18810	27	14	cong	cong	NOUN
ihlr-18810	27	15	.	.	PUNCT
ihlr-18810	28	1	(	(	PUNCT
ihlr-18810	28	2	2012	2012	NUM
ihlr-18810	28	3	)	)	PUNCT
ihlr-18810	28	4	,	,	PUNCT
ihlr-18810	28	5	available	available	ADJ
ihlr-18810	28	6	at	at	ADP
ihlr-18810	28	7	http://www.gpo.gov/fdsys/pkg/bills-112s	http://www.gpo.gov/fdsys/pkg/bills-112s	NOUN
ihlr-18810	28	8	2193is	2193is	PROPN
ihlr-18810	28	9	/	/	SYM
ihlr-18810	28	10	pdflbills1	pdflbills1	NOUN
ihlr-18810	28	11	12s2193is.pdf	12s2193is.pdf	NUM
ihlr-18810	28	12	.	.	PUNCT
ihlr-18810	29	1	3	3	NUM
ihlr-18810	29	2	i	i	PRON
ihlr-18810	29	3	d.	d.	PROPN
ihlr-18810	29	4	at	at	ADP
ihlr-18810	29	5	§	§	PROPN
ihlr-18810	29	6	2	2	NUM
ihlr-18810	29	7	.	.	NOUN
ihlr-18810	29	8	118	118	NUM
ihlr-18810	29	9	vol	vol	NOUN
ihlr-18810	29	10	.	.	PUNCT
ihlr-18810	30	1	10:1	10:1	NUM
ihlr-18810	30	2	510(k	510(k	NUM
ihlr-18810	30	3	)	)	PUNCT
ihlr-18810	30	4	clearance	clearance	NOUN
ihlr-18810	30	5	and/or	and/or	CCONJ
ihlr-18810	30	6	defective	defective	ADJ
ihlr-18810	30	7	devices	device	NOUN
ihlr-18810	30	8	can	can	AUX
ihlr-18810	30	9	be	be	AUX
ihlr-18810	30	10	quickly	quickly	ADV
ihlr-18810	30	11	identified	identify	VERB
ihlr-18810	30	12	and	and	CCONJ
ihlr-18810	30	13	the	the	DET
ihlr-18810	30	14	products	product	NOUN
ihlr-18810	30	15	removed	remove	VERB
ihlr-18810	30	16	from	from	ADP
ihlr-18810	30	17	the	the	DET
ihlr-18810	30	18	market	market	NOUN
ihlr-18810	30	19	.	.	PUNCT
ihlr-18810	31	1	4	4	NUM
ihlr-18810	31	2	doctors	doctor	NOUN
ihlr-18810	31	3	are	be	AUX
ihlr-18810	31	4	also	also	ADV
ihlr-18810	31	5	pushing	push	VERB
ihlr-18810	31	6	for	for	ADP
ihlr-18810	31	7	increases	increase	NOUN
ihlr-18810	31	8	in	in	ADP
ihlr-18810	31	9	reporting	reporting	NOUN
ihlr-18810	31	10	requirements	requirement	NOUN
ihlr-18810	31	11	for	for	ADP
ihlr-18810	31	12	medical	medical	ADJ
ihlr-18810	31	13	devices	device	NOUN
ihlr-18810	31	14	,	,	PUNCT
ihlr-18810	31	15	and	and	CCONJ
ihlr-18810	31	16	the	the	DET
ihlr-18810	31	17	fda	fda	PROPN
ihlr-18810	31	18	has	have	AUX
ihlr-18810	31	19	revealed	reveal	VERB
ihlr-18810	31	20	plans	plan	NOUN
ihlr-18810	31	21	to	to	PART
ihlr-18810	31	22	improve	improve	VERB
ihlr-18810	31	23	their	their	PRON
ihlr-18810	31	24	safety	safety	NOUN
ihlr-18810	31	25	monitoring	monitoring	NOUN
ihlr-18810	31	26	programs.5	programs.5	NOUN
ihlr-18810	32	1	it	it	PRON
ihlr-18810	32	2	seems	seem	VERB
ihlr-18810	32	3	there	there	PRON
ihlr-18810	32	4	is	be	VERB
ihlr-18810	32	5	a	a	DET
ihlr-18810	32	6	consensus	consensus	NOUN
ihlr-18810	32	7	that	that	PRON
ihlr-18810	32	8	more	more	ADJ
ihlr-18810	32	9	can	can	AUX
ihlr-18810	32	10	be	be	AUX
ihlr-18810	32	11	done	do	VERB
ihlr-18810	32	12	to	to	PART
ihlr-18810	32	13	ensure	ensure	VERB
ihlr-18810	32	14	the	the	DET
ihlr-18810	32	15	safety	safety	NOUN
ihlr-18810	32	16	of	of	ADP
ihlr-18810	32	17	medical	medical	ADJ
ihlr-18810	32	18	devices	device	NOUN
ihlr-18810	32	19	available	available	ADJ
ihlr-18810	32	20	in	in	ADP
ihlr-18810	32	21	the	the	DET
ihlr-18810	32	22	united	united	PROPN
ihlr-18810	32	23	states	states	PROPN
ihlr-18810	32	24	market	market	NOUN
ihlr-18810	32	25	.	.	PUNCT
ihlr-18810	33	1	even	even	ADV
ihlr-18810	33	2	in	in	ADP
ihlr-18810	33	3	light	light	NOUN
ihlr-18810	33	4	of	of	ADP
ihlr-18810	33	5	this	this	DET
ihlr-18810	33	6	awareness	awareness	NOUN
ihlr-18810	33	7	,	,	PUNCT
ihlr-18810	33	8	one	one	NUM
ihlr-18810	33	9	aspect	aspect	NOUN
ihlr-18810	33	10	of	of	ADP
ihlr-18810	33	11	medical	medical	ADJ
ihlr-18810	33	12	device	device	NOUN
ihlr-18810	33	13	regulation	regulation	NOUN
ihlr-18810	33	14	has	have	AUX
ihlr-18810	33	15	remained	remain	VERB
ihlr-18810	33	16	almost	almost	ADV
ihlr-18810	33	17	entirely	entirely	ADV
ihlr-18810	33	18	unchanged	unchanged	ADJ
ihlr-18810	33	19	since	since	SCONJ
ihlr-18810	33	20	its	its	PRON
ihlr-18810	33	21	creation	creation	NOUN
ihlr-18810	33	22	in	in	ADP
ihlr-18810	33	23	1976	1976	NUM
ihlr-18810	33	24	:	:	PUNCT
ihlr-18810	33	25	the	the	DET
ihlr-18810	33	26	510(k	510(k	PROPN
ihlr-18810	33	27	)	)	PUNCT
ihlr-18810	33	28	clearance	clearance	NOUN
ihlr-18810	33	29	process	process	NOUN
ihlr-18810	33	30	.	.	PUNCT
ihlr-18810	34	1	through	through	ADP
ihlr-18810	34	2	this	this	DET
ihlr-18810	34	3	process	process	NOUN
ihlr-18810	34	4	,	,	PUNCT
ihlr-18810	34	5	devices	device	NOUN
ihlr-18810	34	6	are	be	AUX
ihlr-18810	34	7	cleared	clear	VERB
ihlr-18810	34	8	for	for	ADP
ihlr-18810	34	9	marketing	marketing	NOUN
ihlr-18810	34	10	(	(	PUNCT
ihlr-18810	34	11	not	not	PART
ihlr-18810	34	12	granted	grant	VERB
ihlr-18810	34	13	an	an	DET
ihlr-18810	34	14	approval	approval	NOUN
ihlr-18810	34	15	based	base	VERB
ihlr-18810	34	16	upon	upon	SCONJ
ihlr-18810	34	17	considerations	consideration	NOUN
ihlr-18810	34	18	of	of	ADP
ihlr-18810	34	19	safety	safety	NOUN
ihlr-18810	34	20	and	and	CCONJ
ihlr-18810	34	21	effectiveness	effectiveness	NOUN
ihlr-18810	34	22	)	)	PUNCT
ihlr-18810	34	23	based	base	VERB
ihlr-18810	34	24	on	on	ADP
ihlr-18810	34	25	their	their	PRON
ihlr-18810	34	26	clinical	clinical	ADJ
ihlr-18810	34	27	similarity	similarity	NOUN
ihlr-18810	34	28	to	to	ADP
ihlr-18810	34	29	devices	device	NOUN
ihlr-18810	34	30	already	already	ADV
ihlr-18810	34	31	available	available	ADJ
ihlr-18810	34	32	on	on	ADP
ihlr-18810	34	33	the	the	DET
ihlr-18810	34	34	market	market	NOUN
ihlr-18810	34	35	at	at	ADP
ihlr-18810	34	36	the	the	DET
ihlr-18810	34	37	inception	inception	NOUN
ihlr-18810	34	38	of	of	ADP
ihlr-18810	34	39	this	this	DET
ihlr-18810	34	40	process.6	process.6	PROPN
ihlr-18810	34	41	in	in	ADP
ihlr-18810	34	42	september	september	PROPN
ihlr-18810	34	43	2009	2009	NUM
ihlr-18810	34	44	,	,	PUNCT
ihlr-18810	34	45	the	the	DET
ihlr-18810	34	46	fda	fda	PROPN
ihlr-18810	34	47	charged	charge	VERB
ihlr-18810	34	48	the	the	DET
ihlr-18810	34	49	institute	institute	NOUN
ihlr-18810	34	50	of	of	ADP
ihlr-18810	34	51	medicine	medicine	PROPN
ihlr-18810	34	52	(	(	PUNCT
ihlr-18810	34	53	iom	iom	PROPN
ihlr-18810	34	54	)	)	PUNCT
ihlr-18810	34	55	with	with	ADP
ihlr-18810	34	56	reviewing	review	VERB
ihlr-18810	34	57	this	this	DET
ihlr-18810	34	58	clearance	clearance	NOUN
ihlr-18810	34	59	process	process	NOUN
ihlr-18810	34	60	and	and	CCONJ
ihlr-18810	34	61	determining	determine	VERB
ihlr-18810	34	62	if	if	SCONJ
ihlr-18810	34	63	it	it	PRON
ihlr-18810	34	64	optimally	optimally	ADV
ihlr-18810	34	65	promotes	promote	VERB
ihlr-18810	34	66	innovation	innovation	NOUN
ihlr-18810	34	67	while	while	SCONJ
ihlr-18810	34	68	protecting	protect	VERB
ihlr-18810	34	69	the	the	DET
ihlr-18810	34	70	public	public	NOUN
ihlr-18810	34	71	's	's	PART
ihlr-18810	34	72	health	health	NOUN
ihlr-18810	34	73	,	,	PUNCT
ihlr-18810	34	74	and	and	CCONJ
ihlr-18810	34	75	if	if	SCONJ
ihlr-18810	34	76	not	not	PART
ihlr-18810	34	77	,	,	PUNCT
ihlr-18810	34	78	what	what	DET
ihlr-18810	34	79	changes	change	NOUN
ihlr-18810	34	80	would	would	AUX
ihlr-18810	34	81	improve	improve	VERB
ihlr-18810	34	82	the	the	DET
ihlr-18810	34	83	process	process	NOUN
ihlr-18810	34	84	'	'	PART
ihlr-18810	34	85	ability	ability	NOUN
ihlr-18810	34	86	to	to	PART
ihlr-18810	34	87	achieve	achieve	VERB
ihlr-18810	34	88	these	these	PRON
ihlr-18810	34	89	goals.7	goals.7	SCONJ
ihlr-18810	34	90	this	this	DET
ihlr-18810	34	91	article	article	NOUN
ihlr-18810	34	92	will	will	AUX
ihlr-18810	34	93	provide	provide	VERB
ihlr-18810	34	94	an	an	DET
ihlr-18810	34	95	overview	overview	NOUN
ihlr-18810	34	96	of	of	ADP
ihlr-18810	34	97	.	.	PUNCT
ihlr-18810	35	1	the	the	DET
ihlr-18810	35	2	fda	fda	PROPN
ihlr-18810	35	3	's	's	PART
ihlr-18810	35	4	current	current	ADJ
ihlr-18810	35	5	regulatory	regulatory	ADJ
ihlr-18810	35	6	and	and	CCONJ
ihlr-18810	35	7	approval	approval	NOUN
ihlr-18810	35	8	processes	process	NOUN
ihlr-18810	35	9	for	for	ADP
ihlr-18810	35	10	medical	medical	ADJ
ihlr-18810	35	11	devices	device	NOUN
ihlr-18810	35	12	and	and	CCONJ
ihlr-18810	35	13	will	will	AUX
ihlr-18810	35	14	discuss	discuss	VERB
ihlr-18810	35	15	the	the	DET
ihlr-18810	35	16	determinations	determination	NOUN
ihlr-18810	35	17	made	make	VERB
ihlr-18810	35	18	by	by	ADP
ihlr-18810	35	19	the	the	DET
ihlr-18810	35	20	iom	iom	PROPN
ihlr-18810	35	21	in	in	ADP
ihlr-18810	35	22	its	its	PRON
ihlr-18810	35	23	evaluation	evaluation	NOUN
ihlr-18810	35	24	of	of	ADP
ihlr-18810	35	25	the	the	DET
ihlr-18810	35	26	510(k	510(k	PROPN
ihlr-18810	35	27	)	)	PUNCT
ihlr-18810	35	28	clearance	clearance	NOUN
ihlr-18810	35	29	process	process	NOUN
ihlr-18810	35	30	.	.	PUNCT
ihlr-18810	36	1	then	then	ADV
ihlr-18810	36	2	the	the	DET
ihlr-18810	36	3	recommendations	recommendation	NOUN
ihlr-18810	36	4	presented	present	VERB
ihlr-18810	36	5	in	in	ADP
ihlr-18810	36	6	the	the	DET
ihlr-18810	36	7	iom	iom	PROPN
ihlr-18810	36	8	report	report	NOUN
ihlr-18810	36	9	and	and	CCONJ
ihlr-18810	36	10	their	their	PRON
ihlr-18810	36	11	likelihood	likelihood	NOUN
ihlr-18810	36	12	to	to	PART
ihlr-18810	36	13	succeed	succeed	VERB
ihlr-18810	36	14	in	in	ADP
ihlr-18810	36	15	improving	improve	VERB
ihlr-18810	36	16	patient	patient	ADJ
ihlr-18810	36	17	safety	safety	NOUN
ihlr-18810	36	18	will	will	AUX
ihlr-18810	36	19	be	be	AUX
ihlr-18810	36	20	4	4	NUM
ihlr-18810	36	21	press	press	NOUN
ihlr-18810	36	22	release	release	NOUN
ihlr-18810	36	23	,	,	PUNCT
ihlr-18810	36	24	office	office	NOUN
ihlr-18810	36	25	of	of	ADP
ihlr-18810	36	26	senator	senator	PROPN
ihlr-18810	36	27	jeff	jeff	PROPN
ihlr-18810	36	28	merkley	merkley	PROPN
ihlr-18810	36	29	,	,	PUNCT
ihlr-18810	36	30	senators	senator	NOUN
ihlr-18810	36	31	introduce	introduce	VERB
ihlr-18810	36	32	bipartisan	bipartisan	ADJ
ihlr-18810	36	33	effort	effort	NOUN
ihlr-18810	36	34	to	to	PART
ihlr-18810	36	35	make	make	VERB
ihlr-18810	36	36	medical	medical	ADJ
ihlr-18810	36	37	devices	device	NOUN
ihlr-18810	36	38	safer	safe	ADJ
ihlr-18810	36	39	:	:	PUNCT
ihlr-18810	36	40	the	the	DET
ihlr-18810	36	41	ensuring	ensure	VERB
ihlr-18810	36	42	safe	safe	ADJ
ihlr-18810	36	43	medical	medical	ADJ
ihlr-18810	36	44	devices	device	NOUN
ihlr-18810	36	45	for	for	ADP
ihlr-18810	36	46	patients	patient	NOUN
ihlr-18810	36	47	act	act	VERB
ihlr-18810	36	48	would	would	AUX
ihlr-18810	36	49	implement	implement	VERB
ihlr-18810	36	50	long	long	ADJ
ihlr-18810	36	51	overdue	overdue	ADJ
ihlr-18810	36	52	reforms	reform	NOUN
ihlr-18810	36	53	and	and	CCONJ
ihlr-18810	36	54	help	help	VERB
ihlr-18810	36	55	save	save	VERB
ihlr-18810	36	56	lives	life	NOUN
ihlr-18810	36	57	(	(	PUNCT
ihlr-18810	36	58	march	march	PROPN
ihlr-18810	36	59	15	15	NUM
ihlr-18810	36	60	,	,	PUNCT
ihlr-18810	36	61	2012	2012	NUM
ihlr-18810	36	62	)	)	PUNCT
ihlr-18810	36	63	,	,	PUNCT
ihlr-18810	36	64	available	available	ADJ
ihlr-18810	36	65	at	at	ADP
ihlr-18810	36	66	http://www.merkley.senate.gov/newsroom/press/release/?id=63dd8e2dbf9a-491c-bfc2-0a33a5096bf7	http://www.merkley.senate.gov/newsroom/press/release/?id=63dd8e2dbf9a-491c-bfc2-0a33a5096bf7	NOUN
ihlr-18810	36	67	(	(	PUNCT
ihlr-18810	36	68	last	last	ADV
ihlr-18810	36	69	visited	visit	VERB
ihlr-18810	36	70	nov	nov	PROPN
ihlr-18810	36	71	.	.	PROPN
ihlr-18810	36	72	25	25	NUM
ihlr-18810	36	73	,	,	PUNCT
ihlr-18810	36	74	2012	2012	NUM
ihlr-18810	36	75	)	)	PUNCT
ihlr-18810	36	76	.	.	PUNCT
ihlr-18810	37	1	the	the	DET
ihlr-18810	37	2	unique	unique	ADJ
ihlr-18810	37	3	device	device	NOUN
ihlr-18810	37	4	identification	identification	NOUN
ihlr-18810	37	5	system	system	NOUN
ihlr-18810	37	6	was	be	AUX
ihlr-18810	37	7	authorized	authorize	VERB
ihlr-18810	37	8	by	by	ADP
ihlr-18810	37	9	the	the	DET
ihlr-18810	37	10	fda	fda	PROPN
ihlr-18810	37	11	amendments	amendment	NOUN
ihlr-18810	37	12	act	act	VERB
ihlr-18810	37	13	of	of	ADP
ihlr-18810	37	14	2007	2007	NUM
ihlr-18810	37	15	,	,	PUNCT
ihlr-18810	37	16	but	but	CCONJ
ihlr-18810	37	17	it	it	PRON
ihlr-18810	37	18	has	have	VERB
ihlr-18810	37	19	yet	yet	ADV
ihlr-18810	37	20	to	to	PART
ihlr-18810	37	21	be	be	AUX
ihlr-18810	37	22	implemented	implement	VERB
ihlr-18810	37	23	.	.	PUNCT
ihlr-18810	38	1	fda	fda	PROPN
ihlr-18810	38	2	amendments	amendment	NOUN
ihlr-18810	38	3	act	act	VERB
ihlr-18810	38	4	of	of	ADP
ihlr-18810	38	5	2007	2007	NUM
ihlr-18810	38	6	,	,	PUNCT
ihlr-18810	38	7	pub	pub	NOUN
ihlr-18810	38	8	.	.	PUNCT
ihlr-18810	39	1	l.	l.	PROPN
ihlr-18810	39	2	no	no	INTJ
ihlr-18810	39	3	.	.	NOUN
ihlr-18810	40	1	110	110	NUM
ihlr-18810	40	2	-	-	SYM
ihlr-18810	40	3	85	85	NUM
ihlr-18810	40	4	,	,	PUNCT
ihlr-18810	40	5	§	§	PROPN
ihlr-18810	40	6	226	226	NUM
ihlr-18810	40	7	,	,	PUNCT
ihlr-18810	40	8	121	121	NUM
ihlr-18810	40	9	stat	stat	NOUN
ihlr-18810	40	10	.	.	PUNCT
ihlr-18810	41	1	823	823	NUM
ihlr-18810	41	2	,	,	PUNCT
ihlr-18810	41	3	854	854	NUM
ihlr-18810	41	4	(	(	PUNCT
ihlr-18810	41	5	2007	2007	NUM
ihlr-18810	41	6	)	)	PUNCT
ihlr-18810	41	7	,	,	PUNCT
ihlr-18810	41	8	available	available	ADJ
ihlr-18810	41	9	at	at	ADP
ihlr-18810	41	10	http://www.gpo.gov/fdsys/pkg/plaw-110publ85/pdf/plaw-11opubl85	http://www.gpo.gov/fdsys/pkg/plaw-110publ85/pdf/plaw-11opubl85	NOUN
ihlr-18810	41	11	.	.	PUNCT
ihlr-18810	42	1	pdf	pdf	NOUN
ihlr-18810	42	2	.	.	PUNCT
ihlr-18810	43	1	5	5	NUM
ihlr-18810	43	2	burton	burton	PROPN
ihlr-18810	43	3	,	,	PUNCT
ihlr-18810	43	4	supra	supra	PROPN
ihlr-18810	43	5	note	note	NOUN
ihlr-18810	43	6	1	1	NUM
ihlr-18810	43	7	.	.	NOUN
ihlr-18810	43	8	6	6	NUM
ihlr-18810	43	9	inst	inst	NOUN
ihlr-18810	43	10	.	.	PROPN
ihlr-18810	43	11	of	of	ADP
ihlr-18810	43	12	med	med	PROPN
ihlr-18810	43	13	.	.	PROPN
ihlr-18810	43	14	,	,	PUNCT
ihlr-18810	43	15	medical	medical	ADJ
ihlr-18810	43	16	devices	device	NOUN
ihlr-18810	43	17	and	and	CCONJ
ihlr-18810	43	18	the	the	DET
ihlr-18810	43	19	public	public	NOUN
ihlr-18810	43	20	's	's	PART
ihlr-18810	43	21	health	health	NOUN
ihlr-18810	43	22	:	:	PUNCT
ihlr-18810	43	23	the	the	DET
ihlr-18810	43	24	fda	fda	PROPN
ihlr-18810	43	25	510(k	510(k	PROPN
ihlr-18810	43	26	)	)	PUNCT
ihlr-18810	43	27	clearance	clearance	NOUN
ihlr-18810	43	28	process	process	NOUN
ihlr-18810	43	29	at	at	ADP
ihlr-18810	43	30	35	35	NUM
ihlr-18810	43	31	years	year	NOUN
ihlr-18810	43	32	15	15	NUM
ihlr-18810	43	33	(	(	PUNCT
ihlr-18810	43	34	2011	2011	NUM
ihlr-18810	43	35	)	)	PUNCT
ihlr-18810	44	1	[	[	X
ihlr-18810	44	2	hereinafter	hereinafter	NOUN
ihlr-18810	44	3	iom	iom	PROPN
ihlr-18810	44	4	report	report	PROPN
ihlr-18810	44	5	]	]	X
ihlr-18810	44	6	.	.	PUNCT
ihlr-18810	45	1	7	7	NUM
ihlr-18810	46	1	i	i	PRON
ihlr-18810	46	2	d.	d.	PROPN
ihlr-18810	46	3	at	at	ADP
ihlr-18810	46	4	16	16	NUM
ihlr-18810	46	5	.	.	PUNCT
ihlr-18810	47	1	2013	2013	NUM
ihlr-18810	47	2	119	119	NUM
ihlr-18810	47	3	indiana	indiana	PROPN
ihlr-18810	47	4	health	health	PROPN
ihlr-18810	47	5	law	law	PROPN
ihlr-18810	47	6	review	review	NOUN
ihlr-18810	47	7	analyzed	analyze	VERB
ihlr-18810	47	8	.	.	PUNCT
ihlr-18810	48	1	finally	finally	ADV
ihlr-18810	48	2	,	,	PUNCT
ihlr-18810	48	3	this	this	DET
ihlr-18810	48	4	paper	paper	NOUN
ihlr-18810	48	5	will	will	AUX
ihlr-18810	48	6	conclude	conclude	VERB
ihlr-18810	48	7	that	that	SCONJ
ihlr-18810	48	8	,	,	PUNCT
ihlr-18810	48	9	although	although	SCONJ
ihlr-18810	48	10	the	the	DET
ihlr-18810	48	11	iom	iom	PROPN
ihlr-18810	48	12	's	's	PART
ihlr-18810	48	13	recommendations	recommendation	NOUN
ihlr-18810	48	14	will	will	AUX
ihlr-18810	48	15	provide	provide	VERB
ihlr-18810	48	16	a	a	DET
ihlr-18810	48	17	large	large	ADJ
ihlr-18810	48	18	step	step	NOUN
ihlr-18810	48	19	in	in	ADP
ihlr-18810	48	20	the	the	DET
ihlr-18810	48	21	right	right	ADJ
ihlr-18810	48	22	direction	direction	NOUN
ihlr-18810	48	23	,	,	PUNCT
ihlr-18810	48	24	more	more	ADJ
ihlr-18810	48	25	must	must	AUX
ihlr-18810	48	26	be	be	AUX
ihlr-18810	48	27	done	do	VERB
ihlr-18810	48	28	to	to	PART
ihlr-18810	48	29	ensure	ensure	VERB
ihlr-18810	48	30	the	the	DET
ihlr-18810	48	31	safety	safety	NOUN
ihlr-18810	48	32	of	of	ADP
ihlr-18810	48	33	the	the	DET
ihlr-18810	48	34	medical	medical	ADJ
ihlr-18810	48	35	devices	device	NOUN
ihlr-18810	48	36	on	on	ADP
ihlr-18810	48	37	the	the	DET
ihlr-18810	48	38	market	market	NOUN
ihlr-18810	48	39	.	.	PUNCT
ihlr-18810	49	1	it	it	PRON
ihlr-18810	49	2	will	will	AUX
ihlr-18810	49	3	be	be	AUX
ihlr-18810	49	4	proposed	propose	VERB
ihlr-18810	49	5	that	that	SCONJ
ihlr-18810	49	6	the	the	DET
ihlr-18810	49	7	best	good	ADJ
ihlr-18810	49	8	way	way	NOUN
ihlr-18810	49	9	to	to	PART
ihlr-18810	49	10	ensure	ensure	VERB
ihlr-18810	49	11	the	the	DET
ihlr-18810	49	12	safety	safety	NOUN
ihlr-18810	49	13	and	and	CCONJ
ihlr-18810	49	14	efficacy	efficacy	NOUN
ihlr-18810	49	15	of	of	ADP
ihlr-18810	49	16	medical	medical	ADJ
ihlr-18810	49	17	devices	device	NOUN
ihlr-18810	49	18	is	be	AUX
ihlr-18810	49	19	for	for	ADP
ihlr-18810	49	20	the	the	DET
ihlr-18810	49	21	federal	federal	ADJ
ihlr-18810	49	22	government	government	NOUN
ihlr-18810	49	23	,	,	PUNCT
ihlr-18810	49	24	in	in	ADP
ihlr-18810	49	25	its	its	PRON
ihlr-18810	49	26	capacity	capacity	NOUN
ihlr-18810	49	27	as	as	ADP
ihlr-18810	49	28	payer	payer	NOUN
ihlr-18810	49	29	under	under	ADP
ihlr-18810	49	30	federal	federal	ADJ
ihlr-18810	49	31	health	health	NOUN
ihlr-18810	49	32	programs	program	NOUN
ihlr-18810	49	33	,	,	PUNCT
ihlr-18810	49	34	to	to	PART
ihlr-18810	49	35	compare	compare	VERB
ihlr-18810	49	36	the	the	DET
ihlr-18810	49	37	effectiveness	effectiveness	NOUN
ihlr-18810	49	38	of	of	ADP
ihlr-18810	49	39	devices	device	NOUN
ihlr-18810	49	40	and	and	CCONJ
ihlr-18810	49	41	medical	medical	ADJ
ihlr-18810	49	42	interventions	intervention	NOUN
ihlr-18810	49	43	already	already	ADV
ihlr-18810	49	44	available	available	ADJ
ihlr-18810	49	45	to	to	ADP
ihlr-18810	49	46	new	new	ADJ
ihlr-18810	49	47	devices	device	NOUN
ihlr-18810	49	48	ready	ready	ADJ
ihlr-18810	49	49	to	to	PART
ihlr-18810	49	50	enter	enter	VERB
ihlr-18810	49	51	the	the	DET
ihlr-18810	49	52	market	market	NOUN
ihlr-18810	49	53	and	and	CCONJ
ihlr-18810	49	54	use	use	VERB
ihlr-18810	49	55	this	this	DET
ihlr-18810	49	56	information	information	NOUN
ihlr-18810	49	57	in	in	ADP
ihlr-18810	49	58	determining	determine	VERB
ihlr-18810	49	59	whether	whether	SCONJ
ihlr-18810	49	60	or	or	CCONJ
ihlr-18810	49	61	not	not	PART
ihlr-18810	49	62	devices	device	NOUN
ihlr-18810	49	63	will	will	AUX
ihlr-18810	49	64	be	be	AUX
ihlr-18810	49	65	covered	cover	VERB
ihlr-18810	49	66	under	under	ADP
ihlr-18810	49	67	either	either	DET
ihlr-18810	49	68	program	program	NOUN
ihlr-18810	49	69	.	.	PUNCT
ihlr-18810	50	1	in	in	ADP
ihlr-18810	50	2	this	this	DET
ihlr-18810	50	3	way	way	NOUN
ihlr-18810	50	4	,	,	PUNCT
ihlr-18810	50	5	the	the	DET
ihlr-18810	50	6	u.s	u.s	PROPN
ihlr-18810	50	7	.	.	PROPN
ihlr-18810	50	8	will	will	AUX
ihlr-18810	50	9	not	not	PART
ihlr-18810	50	10	fall	fall	VERB
ihlr-18810	50	11	behind	behind	ADP
ihlr-18810	50	12	other	other	ADJ
ihlr-18810	50	13	nations	nation	NOUN
ihlr-18810	50	14	with	with	ADP
ihlr-18810	50	15	regard	regard	NOUN
ihlr-18810	50	16	to	to	ADP
ihlr-18810	50	17	availability	availability	NOUN
ihlr-18810	50	18	of	of	ADP
ihlr-18810	50	19	cutting	cut	VERB
ihlr-18810	50	20	edge	edge	NOUN
ihlr-18810	50	21	technologies	technology	NOUN
ihlr-18810	50	22	in	in	ADP
ihlr-18810	50	23	medicine	medicine	NOUN
ihlr-18810	50	24	by	by	ADP
ihlr-18810	50	25	overburdening	overburden	VERB
ihlr-18810	50	26	the	the	DET
ihlr-18810	50	27	fda	fda	PROPN
ihlr-18810	50	28	with	with	ADP
ihlr-18810	50	29	extensive	extensive	ADJ
ihlr-18810	50	30	evaluations	evaluation	NOUN
ihlr-18810	50	31	of	of	ADP
ihlr-18810	50	32	devices	device	NOUN
ihlr-18810	50	33	.	.	PUNCT
ihlr-18810	51	1	instead	instead	ADV
ihlr-18810	51	2	,	,	PUNCT
ihlr-18810	51	3	device	device	NOUN
ihlr-18810	51	4	manufacturers	manufacturer	NOUN
ihlr-18810	51	5	and	and	CCONJ
ihlr-18810	51	6	patients	patient	NOUN
ihlr-18810	51	7	both	both	PRON
ihlr-18810	51	8	will	will	AUX
ihlr-18810	51	9	benefit	benefit	VERB
ihlr-18810	51	10	from	from	ADP
ihlr-18810	51	11	prompt	prompt	ADJ
ihlr-18810	51	12	availability	availability	NOUN
ihlr-18810	51	13	of	of	ADP
ihlr-18810	51	14	reasonably	reasonably	ADV
ihlr-18810	51	15	safe	safe	ADJ
ihlr-18810	51	16	medical	medical	ADJ
ihlr-18810	51	17	devices	device	NOUN
ihlr-18810	51	18	,	,	PUNCT
ihlr-18810	51	19	the	the	DET
ihlr-18810	51	20	assured	assured	ADJ
ihlr-18810	51	21	continuation	continuation	NOUN
ihlr-18810	51	22	of	of	ADP
ihlr-18810	51	23	research	research	NOUN
ihlr-18810	51	24	into	into	ADP
ihlr-18810	51	25	the	the	DET
ihlr-18810	51	26	comparative	comparative	ADJ
ihlr-18810	51	27	effectiveness	effectiveness	NOUN
ihlr-18810	51	28	of	of	ADP
ihlr-18810	51	29	new	new	ADJ
ihlr-18810	51	30	devices	device	NOUN
ihlr-18810	51	31	,	,	PUNCT
ihlr-18810	51	32	and	and	CCONJ
ihlr-18810	51	33	the	the	DET
ihlr-18810	51	34	availability	availability	NOUN
ihlr-18810	51	35	of	of	ADP
ihlr-18810	51	36	this	this	DET
ihlr-18810	51	37	information	information	NOUN
ihlr-18810	51	38	to	to	PART
ihlr-18810	51	39	guide	guide	VERB
ihlr-18810	51	40	medical	medical	ADJ
ihlr-18810	51	41	decision	decision	NOUN
ihlr-18810	51	42	making	make	VERB
ihlr-18810	51	43	and	and	CCONJ
ihlr-18810	51	44	ensure	ensure	VERB
ihlr-18810	51	45	patients	patient	NOUN
ihlr-18810	51	46	receive	receive	VERB
ihlr-18810	51	47	the	the	DET
ihlr-18810	51	48	safest	safe	ADJ
ihlr-18810	51	49	and	and	CCONJ
ihlr-18810	51	50	most	most	ADV
ihlr-18810	51	51	effective	effective	ADJ
ihlr-18810	51	52	treatments	treatment	NOUN
ihlr-18810	51	53	available	available	ADJ
ihlr-18810	51	54	.	.	PUNCT
ihlr-18810	52	1	ii	ii	X
ihlr-18810	52	2	.	.	PUNCT
ihlr-18810	53	1	federal	federal	ADJ
ihlr-18810	53	2	regulation	regulation	NOUN
ihlr-18810	53	3	of	of	ADP
ihlr-18810	53	4	medical	medical	ADJ
ihlr-18810	53	5	device	device	NOUN
ihlr-18810	53	6	safety	safety	NOUN
ihlr-18810	53	7	and	and	CCONJ
ihlr-18810	53	8	efficacy	efficacy	NOUN
ihlr-18810	53	9	a.	a.	NOUN
ihlr-18810	53	10	history	history	NOUN
ihlr-18810	53	11	the	the	DET
ihlr-18810	53	12	first	first	ADJ
ihlr-18810	53	13	significant	significant	ADJ
ihlr-18810	53	14	action	action	NOUN
ihlr-18810	53	15	of	of	ADP
ihlr-18810	53	16	congress	congress	PROPN
ihlr-18810	53	17	in	in	ADP
ihlr-18810	53	18	the	the	DET
ihlr-18810	53	19	realm	realm	NOUN
ihlr-18810	53	20	of	of	ADP
ihlr-18810	53	21	public	public	ADJ
ihlr-18810	53	22	health	health	NOUN
ihlr-18810	53	23	and	and	CCONJ
ihlr-18810	53	24	safety	safety	NOUN
ihlr-18810	53	25	occurred	occur	VERB
ihlr-18810	53	26	in	in	ADP
ihlr-18810	53	27	1906	1906	NUM
ihlr-18810	53	28	when	when	SCONJ
ihlr-18810	53	29	it	it	PRON
ihlr-18810	53	30	passed	pass	VERB
ihlr-18810	53	31	the	the	DET
ihlr-18810	53	32	pure	pure	ADJ
ihlr-18810	53	33	food	food	NOUN
ihlr-18810	53	34	and	and	CCONJ
ihlr-18810	53	35	drug	drug	NOUN
ihlr-18810	53	36	act.8	act.8	PROPN
ihlr-18810	53	37	this	this	DET
ihlr-18810	53	38	act	act	NOUN
ihlr-18810	53	39	prohibited	prohibit	VERB
ihlr-18810	53	40	the	the	DET
ihlr-18810	53	41	manufacture	manufacture	NOUN
ihlr-18810	53	42	and	and	CCONJ
ihlr-18810	53	43	interstate	interstate	ADJ
ihlr-18810	53	44	shipment	shipment	NOUN
ihlr-18810	53	45	of	of	ADP
ihlr-18810	53	46	adulterated	adulterate	VERB
ihlr-18810	53	47	,	,	PUNCT
ihlr-18810	53	48	misbranded	misbrande	VERB
ihlr-18810	53	49	,	,	PUNCT
ihlr-18810	53	50	or	or	CCONJ
ihlr-18810	53	51	harmful	harmful	ADJ
ihlr-18810	53	52	foods	food	NOUN
ihlr-18810	53	53	,	,	PUNCT
ihlr-18810	53	54	drugs	drug	NOUN
ihlr-18810	53	55	,	,	PUNCT
ihlr-18810	53	56	and	and	CCONJ
ihlr-18810	53	57	liquors.9	liquors.9	PROPN
ihlr-18810	53	58	in	in	ADP
ihlr-18810	53	59	1938	1938	NUM
ihlr-18810	53	60	federal	federal	ADJ
ihlr-18810	53	61	regulation	regulation	NOUN
ihlr-18810	53	62	was	be	AUX
ihlr-18810	53	63	expanded	expand	VERB
ihlr-18810	53	64	to	to	PART
ihlr-18810	53	65	cover	cover	VERB
ihlr-18810	53	66	misbranded	misbrande	VERB
ihlr-18810	53	67	or	or	CCONJ
ihlr-18810	53	68	adulterated	adulterate	VERB
ihlr-18810	53	69	cosmetics	cosmetic	NOUN
ihlr-18810	53	70	and	and	CCONJ
ihlr-18810	53	71	medical	medical	ADJ
ihlr-18810	53	72	devices	device	NOUN
ihlr-18810	53	73	as	as	ADV
ihlr-18810	53	74	well	well	ADV
ihlr-18810	53	75	through	through	ADP
ihlr-18810	53	76	the	the	DET
ihlr-18810	53	77	passage	passage	NOUN
ihlr-18810	53	78	of	of	ADP
ihlr-18810	53	79	the	the	DET
ihlr-18810	53	80	federal	federal	ADJ
ihlr-18810	53	81	food	food	NOUN
ihlr-18810	53	82	,	,	PUNCT
ihlr-18810	53	83	drug	drug	NOUN
ihlr-18810	53	84	and	and	CCONJ
ihlr-18810	53	85	cosmetic	cosmetic	ADJ
ihlr-18810	53	86	act	act	NOUN
ihlr-18810	53	87	(	(	PUNCT
ihlr-18810	53	88	fdca).1o	fdca).1o	PROPN
ihlr-18810	53	89	the	the	DET
ihlr-18810	53	90	fdca	fdca	NOUN
ihlr-18810	53	91	prohibited	prohibit	VERB
ihlr-18810	53	92	the	the	DET
ihlr-18810	53	93	adulteration	adulteration	NOUN
ihlr-18810	53	94	or	or	CCONJ
ihlr-18810	53	95	8	8	NUM
ihlr-18810	53	96	the	the	DET
ihlr-18810	53	97	federal	federal	ADJ
ihlr-18810	53	98	food	food	NOUN
ihlr-18810	53	99	and	and	CCONJ
ihlr-18810	53	100	drugs	drug	NOUN
ihlr-18810	53	101	act	act	NOUN
ihlr-18810	53	102	of	of	ADP
ihlr-18810	53	103	1906	1906	NUM
ihlr-18810	53	104	,	,	PUNCT
ihlr-18810	53	105	21	21	NUM
ihlr-18810	53	106	u.s.c	u.s.c	ADJ
ihlr-18810	53	107	.	.	PUNCT
ihlr-18810	54	1	§	§	PROPN
ihlr-18810	54	2	1	1	NUM
ihlr-18810	54	3	(	(	PUNCT
ihlr-18810	54	4	repealed	repeal	VERB
ihlr-18810	54	5	1938	1938	NUM
ihlr-18810	54	6	)	)	PUNCT
ihlr-18810	54	7	.	.	PUNCT
ihlr-18810	55	1	9	9	NUM
ihlr-18810	55	2	i	i	PRON
ihlr-18810	55	3	d.	d.	PROPN
ihlr-18810	55	4	10	10	NUM
ihlr-18810	55	5	the	the	DET
ihlr-18810	55	6	federal	federal	ADJ
ihlr-18810	55	7	food	food	NOUN
ihlr-18810	55	8	,	,	PUNCT
ihlr-18810	55	9	drug	drug	NOUN
ihlr-18810	55	10	and	and	CCONJ
ihlr-18810	55	11	cosmetic	cosmetic	ADJ
ihlr-18810	55	12	act	act	NOUN
ihlr-18810	55	13	of	of	ADP
ihlr-18810	55	14	1938	1938	NUM
ihlr-18810	55	15	,	,	PUNCT
ihlr-18810	55	16	21	21	NUM
ihlr-18810	55	17	u.s.c	u.s.c	ADJ
ihlr-18810	55	18	.	.	PUNCT
ihlr-18810	56	1	§	§	PROPN
ihlr-18810	56	2	301	301	NUM
ihlr-18810	56	3	(	(	PUNCT
ihlr-18810	56	4	1938	1938	NUM
ihlr-18810	56	5	)	)	PUNCT
ihlr-18810	56	6	.	.	PUNCT
ihlr-18810	57	1	120	120	NUM
ihlr-18810	57	2	vol	vol	NOUN
ihlr-18810	57	3	.	.	PUNCT
ihlr-18810	58	1	10:1	10:1	NUM
ihlr-18810	58	2	510(k	510(k	X
ihlr-18810	58	3	)	)	PUNCT
ihlr-18810	58	4	clearance	clearance	NOUN
ihlr-18810	58	5	misbranding	misbranding	NOUN
ihlr-18810	58	6	of	of	ADP
ihlr-18810	58	7	medical	medical	ADJ
ihlr-18810	58	8	devices	device	NOUN
ihlr-18810	58	9	,	,	PUNCT
ihlr-18810	58	10	and	and	CCONJ
ihlr-18810	58	11	gave	give	VERB
ihlr-18810	58	12	the	the	DET
ihlr-18810	58	13	fda	fda	PROPN
ihlr-18810	58	14	authority	authority	NOUN
ihlr-18810	58	15	to	to	PART
ihlr-18810	58	16	inspect	inspect	VERB
ihlr-18810	58	17	manufacturers	manufacturer	NOUN
ihlr-18810	58	18	of	of	ADP
ihlr-18810	58	19	medical	medical	ADJ
ihlr-18810	58	20	devices	device	NOUN
ihlr-18810	58	21	.	.	PUNCT
ihlr-18810	58	22	"	"	PUNCT
ihlr-18810	59	1	however	however	ADV
ihlr-18810	59	2	,	,	PUNCT
ihlr-18810	59	3	although	although	SCONJ
ihlr-18810	59	4	the	the	DET
ihlr-18810	59	5	fdca	fdca	NOUN
ihlr-18810	59	6	established	establish	VERB
ihlr-18810	59	7	a	a	DET
ihlr-18810	59	8	premarket	premarket	NOUN
ihlr-18810	59	9	approval	approval	NOUN
ihlr-18810	59	10	process	process	NOUN
ihlr-18810	59	11	based	base	VERB
ihlr-18810	59	12	on	on	ADP
ihlr-18810	59	13	evaluations	evaluation	NOUN
ihlr-18810	59	14	of	of	ADP
ihlr-18810	59	15	safety	safety	NOUN
ihlr-18810	59	16	for	for	ADP
ihlr-18810	59	17	drugs	drug	NOUN
ihlr-18810	59	18	,	,	PUNCT
ihlr-18810	59	19	it	it	PRON
ihlr-18810	59	20	did	do	AUX
ihlr-18810	59	21	not	not	PART
ihlr-18810	59	22	regulate	regulate	VERB
ihlr-18810	59	23	the	the	DET
ihlr-18810	59	24	ability	ability	NOUN
ihlr-18810	59	25	of	of	ADP
ihlr-18810	59	26	new	new	ADJ
ihlr-18810	59	27	medical	medical	ADJ
ihlr-18810	59	28	devices	device	NOUN
ihlr-18810	59	29	to	to	PART
ihlr-18810	59	30	enter	enter	VERB
ihlr-18810	59	31	the	the	DET
ihlr-18810	59	32	market	market	NOUN
ihlr-18810	59	33	.	.	PUNCT
ihlr-18810	60	1	instead	instead	ADV
ihlr-18810	60	2	,	,	PUNCT
ihlr-18810	60	3	the	the	DET
ihlr-18810	60	4	fda	fda	PROPN
ihlr-18810	60	5	could	could	AUX
ihlr-18810	60	6	only	only	ADV
ihlr-18810	60	7	seize	seize	VERB
ihlr-18810	60	8	dangerous	dangerous	ADJ
ihlr-18810	60	9	devices	device	NOUN
ihlr-18810	60	10	on	on	ADP
ihlr-18810	60	11	the	the	DET
ihlr-18810	60	12	market	market	NOUN
ihlr-18810	60	13	and	and	CCONJ
ihlr-18810	60	14	rely	rely	VERB
ihlr-18810	60	15	on	on	ADP
ihlr-18810	60	16	injunction	injunction	NOUN
ihlr-18810	60	17	actions	action	NOUN
ihlr-18810	60	18	to	to	PART
ihlr-18810	60	19	prevent	prevent	VERB
ihlr-18810	60	20	dangerous	dangerous	ADJ
ihlr-18810	60	21	devices	device	NOUN
ihlr-18810	60	22	from	from	ADP
ihlr-18810	60	23	returning	return	VERB
ihlr-18810	60	24	to	to	ADP
ihlr-18810	60	25	the	the	DET
ihlr-18810	60	26	market	market	NOUN
ihlr-18810	60	27	.	.	PUNCT
ihlr-18810	61	1	12	12	NUM
ihlr-18810	61	2	for	for	ADP
ihlr-18810	61	3	many	many	ADJ
ihlr-18810	61	4	decades	decade	NOUN
ihlr-18810	61	5	this	this	DET
ihlr-18810	61	6	act	act	NOUN
ihlr-18810	61	7	and	and	CCONJ
ihlr-18810	61	8	its	its	PRON
ihlr-18810	61	9	corresponding	correspond	VERB
ihlr-18810	61	10	regulations	regulation	NOUN
ihlr-18810	61	11	constituted	constitute	VERB
ihlr-18810	61	12	the	the	DET
ihlr-18810	61	13	parameters	parameter	NOUN
ihlr-18810	61	14	of	of	ADP
ihlr-18810	61	15	federal	federal	ADJ
ihlr-18810	61	16	oversight	oversight	NOUN
ihlr-18810	61	17	of	of	ADP
ihlr-18810	61	18	the	the	DET
ihlr-18810	61	19	medical	medical	ADJ
ihlr-18810	61	20	device	device	NOUN
ihlr-18810	61	21	industry	industry	NOUN
ihlr-18810	61	22	.	.	PUNCT
ihlr-18810	62	1	in	in	ADP
ihlr-18810	62	2	the	the	DET
ihlr-18810	62	3	1970s	1970	NOUN
ihlr-18810	62	4	several	several	ADJ
ihlr-18810	62	5	devices	device	NOUN
ihlr-18810	62	6	began	begin	VERB
ihlr-18810	62	7	to	to	PART
ihlr-18810	62	8	draw	draw	VERB
ihlr-18810	62	9	the	the	DET
ihlr-18810	62	10	attention	attention	NOUN
ihlr-18810	62	11	of	of	ADP
ihlr-18810	62	12	patients	patient	NOUN
ihlr-18810	62	13	,	,	PUNCT
ihlr-18810	62	14	the	the	DET
ihlr-18810	62	15	fda	fda	PROPN
ihlr-18810	62	16	,	,	PUNCT
ihlr-18810	62	17	and	and	CCONJ
ihlr-18810	62	18	congress	congress	PROPN
ihlr-18810	62	19	to	to	ADP
ihlr-18810	62	20	the	the	DET
ihlr-18810	62	21	possible	possible	ADJ
ihlr-18810	62	22	health	health	NOUN
ihlr-18810	62	23	risks	risk	NOUN
ihlr-18810	62	24	of	of	ADP
ihlr-18810	62	25	medical	medical	ADJ
ihlr-18810	62	26	devices.13	devices.13	PROPN
ihlr-18810	62	27	in	in	ADP
ihlr-18810	62	28	response	response	NOUN
ihlr-18810	62	29	to	to	ADP
ihlr-18810	62	30	these	these	DET
ihlr-18810	62	31	concerns	concern	NOUN
ihlr-18810	62	32	,	,	PUNCT
ihlr-18810	62	33	congress	congress	PROPN
ihlr-18810	62	34	passed	pass	VERB
ihlr-18810	62	35	the	the	DET
ihlr-18810	62	36	medical	medical	ADJ
ihlr-18810	62	37	device	device	NOUN
ihlr-18810	62	38	amendments	amendment	NOUN
ihlr-18810	62	39	(	(	PUNCT
ihlr-18810	62	40	mda	mda	PROPN
ihlr-18810	62	41	)	)	PUNCT
ihlr-18810	62	42	to	to	ADP
ihlr-18810	62	43	the	the	DET
ihlr-18810	62	44	fdca.14	fdca.14	NOUN
ihlr-18810	62	45	the	the	DET
ihlr-18810	62	46	mda	mda	PROPN
ihlr-18810	62	47	sets	set	VERB
ihlr-18810	62	48	out	out	ADP
ihlr-18810	62	49	three	three	NUM
ihlr-18810	62	50	categories	category	NOUN
ihlr-18810	62	51	of	of	ADP
ihlr-18810	62	52	medical	medical	ADJ
ihlr-18810	62	53	devices	device	NOUN
ihlr-18810	62	54	,	,	PUNCT
ihlr-18810	62	55	and	and	CCONJ
ihlr-18810	62	56	classifies	classify	VERB
ihlr-18810	62	57	them	they	PRON
ihlr-18810	62	58	based	base	VERB
ihlr-18810	62	59	on	on	ADP
ihlr-18810	62	60	the	the	DET
ihlr-18810	62	61	risk	risk	NOUN
ihlr-18810	62	62	they	they	PRON
ihlr-18810	62	63	pose	pose	VERB
ihlr-18810	62	64	to	to	ADP
ihlr-18810	62	65	the	the	DET
ihlr-18810	62	66	public	public	NOUN
ihlr-18810	62	67	.	.	PUNCT
ihlr-18810	63	1	class	class	NOUN
ihlr-18810	63	2	i	i	NOUN
ihlr-18810	63	3	devices	device	NOUN
ihlr-18810	63	4	are	be	AUX
ihlr-18810	63	5	those	those	PRON
ihlr-18810	63	6	which	which	PRON
ihlr-18810	63	7	present	present	VERB
ihlr-18810	63	8	no	no	DET
ihlr-18810	63	9	"	"	PUNCT
ihlr-18810	63	10	unreasonable	unreasonable	ADJ
ihlr-18810	63	11	risk	risk	NOUN
ihlr-18810	63	12	of	of	ADP
ihlr-18810	63	13	illness	illness	NOUN
ihlr-18810	63	14	or	or	CCONJ
ihlr-18810	63	15	injury	injury	NOUN
ihlr-18810	63	16	,	,	PUNCT
ihlr-18810	63	17	"	"	PUNCT
ihlr-18810	63	18	and	and	CCONJ
ihlr-18810	63	19	are	be	AUX
ihlr-18810	63	20	subject	subject	ADJ
ihlr-18810	63	21	only	only	ADV
ihlr-18810	63	22	to	to	ADP
ihlr-18810	63	23	general	general	ADJ
ihlr-18810	63	24	regulatory	regulatory	ADJ
ihlr-18810	63	25	controls15	controls15	NOUN
ihlr-18810	63	26	such	such	ADJ
ihlr-18810	63	27	as	as	ADP
ihlr-18810	63	28	regulations	regulation	NOUN
ihlr-18810	63	29	pertaining	pertain	VERB
ihlr-18810	63	30	to	to	ADP
ihlr-18810	63	31	good	good	ADJ
ihlr-18810	63	32	manufacturing	manufacturing	NOUN
ihlr-18810	63	33	practices	practice	NOUN
ihlr-18810	63	34	,	,	PUNCT
ihlr-18810	63	35	labeling	labeling	NOUN
ihlr-18810	63	36	,	,	PUNCT
ihlr-18810	63	37	and	and	CCONJ
ihlr-18810	63	38	adverse	adverse	ADJ
ihlr-18810	63	39	experience	experience	NOUN
ihlr-18810	63	40	reporting	report	VERB
ihlr-18810	63	41	(	(	PUNCT
ihlr-18810	63	42	discussed	discuss	VERB
ihlr-18810	63	43	in	in	ADP
ihlr-18810	63	44	greater	great	ADJ
ihlr-18810	63	45	detail	detail	NOUN
ihlr-18810	63	46	below).16	below).16	PROPN
ihlr-18810	63	47	class	class	NOUN
ihlr-18810	63	48	i	i	NOUN
ihlr-18810	63	49	devices	device	NOUN
ihlr-18810	63	50	include	include	VERB
ihlr-18810	63	51	hand	hand	NOUN
ihlr-18810	63	52	held	hold	VERB
ihlr-18810	63	53	surgical	surgical	ADJ
ihlr-18810	63	54	instruments	instrument	NOUN
ihlr-18810	63	55	,	,	PUNCT
ihlr-18810	63	56	latex	latex	NOUN
ihlr-18810	63	57	gloves	glove	NOUN
ihlr-18810	63	58	,	,	PUNCT
ihlr-18810	63	59	and	and	CCONJ
ihlr-18810	63	60	bandages	bandage	NOUN
ihlr-18810	63	61	.	.	PUNCT
ihlr-18810	63	62	'	'	PUNCT
ihlr-18810	64	1	7	7	NUM
ihlr-18810	64	2	class	class	NOUN
ihlr-18810	64	3	ii	ii	NOUN
ihlr-18810	64	4	devices	device	NOUN
ihlr-18810	64	5	present	present	VERB
ihlr-18810	64	6	more	more	ADJ
ihlr-18810	64	7	risk	risk	NOUN
ihlr-18810	64	8	than	than	ADP
ihlr-18810	64	9	class	class	NOUN
ihlr-18810	64	10	i	i	PROPN
ihlr-18810	64	11	,	,	PUNCT
ihlr-18810	64	12	and	and	CCONJ
ihlr-18810	64	13	as	as	SCONJ
ihlr-18810	64	14	a	a	DET
ihlr-18810	64	15	consequence	consequence	NOUN
ihlr-18810	64	16	are	be	AUX
ihlr-18810	64	17	subject	subject	ADJ
ihlr-18810	64	18	to	to	ADP
ihlr-18810	64	19	special	special	ADJ
ihlr-18810	64	20	controls	control	NOUN
ihlr-18810	64	21	which	which	PRON
ihlr-18810	64	22	include	include	VERB
ihlr-18810	64	23	the	the	DET
ihlr-18810	64	24	"	"	PUNCT
ihlr-18810	64	25	promulgation	promulgation	NOUN
ihlr-18810	64	26	of	of	ADP
ihlr-18810	64	27	performance	performance	NOUN
ihlr-18810	64	28	standards	standard	NOUN
ihlr-18810	64	29	,	,	PUNCT
ihlr-18810	64	30	postmarket	postmarket	ADJ
ihlr-18810	64	31	surveillance	surveillance	NOUN
ihlr-18810	64	32	,	,	PUNCT
ihlr-18810	64	33	patient	patient	ADJ
ihlr-18810	64	34	11	11	NUM
ihlr-18810	64	35	nancy	nancy	PROPN
ihlr-18810	64	36	w.	w.	PROPN
ihlr-18810	64	37	mathewson	mathewson	PROPN
ihlr-18810	64	38	,	,	PUNCT
ihlr-18810	64	39	history	history	NOUN
ihlr-18810	64	40	of	of	ADP
ihlr-18810	64	41	medical	medical	ADJ
ihlr-18810	64	42	device	device	NOUN
ihlr-18810	64	43	regulation	regulation	NOUN
ihlr-18810	64	44	,	,	PUNCT
ihlr-18810	64	45	in	in	ADP
ihlr-18810	64	46	medical	medical	ADJ
ihlr-18810	64	47	device	device	NOUN
ihlr-18810	64	48	regulation	regulation	NOUN
ihlr-18810	64	49	&	&	CCONJ
ihlr-18810	64	50	compliance	compliance	NOUN
ihlr-18810	64	51	1	1	NUM
ihlr-18810	64	52	,	,	PUNCT
ihlr-18810	64	53	1	1	NUM
ihlr-18810	64	54	(	(	PUNCT
ihlr-18810	64	55	stephen	stephen	PROPN
ihlr-18810	64	56	d.	d.	PROPN
ihlr-18810	64	57	terman	terman	PROPN
ihlr-18810	64	58	&	&	CCONJ
ihlr-18810	64	59	neil	neil	PROPN
ihlr-18810	64	60	f.	f.	PROPN
ihlr-18810	64	61	o'flaherty	o'flaherty	PROPN
ihlr-18810	64	62	eds	eds	PROPN
ihlr-18810	64	63	.	.	PROPN
ihlr-18810	64	64	,	,	PUNCT
ihlr-18810	64	65	2010	2010	NUM
ihlr-18810	64	66	)	)	PUNCT
ihlr-18810	64	67	,	,	PUNCT
ihlr-18810	64	68	available	available	ADJ
ihlr-18810	64	69	at	at	ADP
ihlr-18810	64	70	http://www.fdli.org/pdf/	http://www.fdli.org/pdf/	NOUN
ihlr-18810	64	71	pubs	pub	NOUN
ihlr-18810	64	72	/	/	SYM
ihlr-18810	64	73	fdli	fdli	NOUN
ihlr-18810	64	74	-	-	PUNCT
ihlr-18810	64	75	medical	medical	ADJ
ihlr-18810	64	76	-	-	PUNCT
ihlr-18810	64	77	device.pdf	device.pdf	NOUN
ihlr-18810	64	78	.	.	NOUN
ihlr-18810	64	79	12	12	NUM
ihlr-18810	65	1	i	i	PROPN
ihlr-18810	65	2	d.	d.	PROPN
ihlr-18810	65	3	13	13	NUM
ihlr-18810	65	4	medtronic	medtronic	PROPN
ihlr-18810	65	5	,	,	PUNCT
ihlr-18810	65	6	inc	inc	PROPN
ihlr-18810	65	7	.	.	PROPN
ihlr-18810	66	1	v.	v.	PROPN
ihlr-18810	66	2	lohr	lohr	PROPN
ihlr-18810	66	3	,	,	PUNCT
ihlr-18810	66	4	518	518	NUM
ihlr-18810	66	5	u.s	u.s	PROPN
ihlr-18810	66	6	.	.	PROPN
ihlr-18810	66	7	470	470	NUM
ihlr-18810	66	8	,	,	PUNCT
ihlr-18810	66	9	475	475	NUM
ihlr-18810	66	10	-	-	SYM
ihlr-18810	66	11	76	76	NUM
ihlr-18810	66	12	(	(	PUNCT
ihlr-18810	66	13	1996	1996	NUM
ihlr-18810	66	14	)	)	PUNCT
ihlr-18810	66	15	.	.	PUNCT
ihlr-18810	67	1	14	14	NUM
ihlr-18810	68	1	the	the	DET
ihlr-18810	68	2	medical	medical	ADJ
ihlr-18810	68	3	device	device	NOUN
ihlr-18810	68	4	amendments	amendment	NOUN
ihlr-18810	68	5	,	,	PUNCT
ihlr-18810	68	6	21	21	NUM
ihlr-18810	68	7	u.s.c	u.s.c	ADJ
ihlr-18810	68	8	.	.	PUNCT
ihlr-18810	69	1	§	§	PROPN
ihlr-18810	69	2	360c	360c	PROPN
ihlr-18810	69	3	(	(	PUNCT
ihlr-18810	69	4	2012	2012	NUM
ihlr-18810	69	5	)	)	PUNCT
ihlr-18810	69	6	.	.	PUNCT
ihlr-18810	70	1	15	15	NUM
ihlr-18810	70	2	21	21	NUM
ihlr-18810	70	3	u.s.c	u.s.c	NOUN
ihlr-18810	70	4	.	.	PUNCT
ihlr-18810	71	1	§	§	PROPN
ihlr-18810	71	2	360c(a)(1)(a)(ii)(ii	360c(a)(1)(a)(ii)(ii	NUM
ihlr-18810	71	3	)	)	PUNCT
ihlr-18810	71	4	(	(	PUNCT
ihlr-18810	71	5	2012	2012	NUM
ihlr-18810	71	6	)	)	PUNCT
ihlr-18810	71	7	.	.	PUNCT
ihlr-18810	72	1	16	16	NUM
ihlr-18810	72	2	robert	robert	PROPN
ihlr-18810	72	3	b.	b.	PROPN
ihlr-18810	72	4	leflar	leflar	PROPN
ihlr-18810	72	5	&	&	CCONJ
ihlr-18810	72	6	robert	robert	PROPN
ihlr-18810	72	7	s.	s.	PROPN
ihlr-18810	72	8	adler	adler	PROPN
ihlr-18810	72	9	,	,	PUNCT
ihlr-18810	72	10	the	the	DET
ihlr-18810	72	11	preemption	preemption	NOUN
ihlr-18810	72	12	pentad	pentad	NOUN
ihlr-18810	72	13	:	:	PUNCT
ihlr-18810	72	14	federal	federal	ADJ
ihlr-18810	72	15	preemption	preemption	NOUN
ihlr-18810	72	16	of	of	ADP
ihlr-18810	72	17	products	product	NOUN
ihlr-18810	72	18	liability	liability	NOUN
ihlr-18810	72	19	claims	claim	NOUN
ihlr-18810	72	20	after	after	ADP
ihlr-18810	72	21	medtronic	medtronic	NOUN
ihlr-18810	72	22	,	,	PUNCT
ihlr-18810	72	23	64	64	NUM
ihlr-18810	72	24	tenn	tenn	PROPN
ihlr-18810	72	25	.	.	PUNCT
ihlr-18810	72	26	l.	l.	PROPN
ihlr-18810	72	27	rev	rev	PROPN
ihlr-18810	72	28	.	.	PROPN
ihlr-18810	72	29	691	691	NUM
ihlr-18810	72	30	,	,	PUNCT
ihlr-18810	72	31	721	721	NUM
ihlr-18810	72	32	(	(	PUNCT
ihlr-18810	72	33	1997	1997	NUM
ihlr-18810	72	34	)	)	PUNCT
ihlr-18810	72	35	.	.	PUNCT
ihlr-18810	73	1	17	17	NUM
ihlr-18810	73	2	medical	medical	ADJ
ihlr-18810	73	3	devices	device	NOUN
ihlr-18810	73	4	:	:	PUNCT
ihlr-18810	73	5	general	general	ADJ
ihlr-18810	73	6	and	and	CCONJ
ihlr-18810	73	7	special	special	ADJ
ihlr-18810	73	8	controls	control	NOUN
ihlr-18810	73	9	,	,	PUNCT
ihlr-18810	73	10	u.s	u.s	PROPN
ihlr-18810	73	11	.	.	PROPN
ihlr-18810	73	12	food	food	NOUN
ihlr-18810	73	13	and	and	CCONJ
ihlr-18810	73	14	drug	drug	NOUN
ihlr-18810	73	15	admin	admin	PROPN
ihlr-18810	73	16	.	.	PUNCT
ihlr-18810	73	17	,	,	PUNCT
ihlr-18810	73	18	http://www.fda.gov/medicaldevices/deviceregulationand	http://www.fda.gov/medicaldevices/deviceregulationand	ADV
ihlr-18810	73	19	guidance	guidance	NOUN
ihlr-18810	73	20	/	/	SYM
ihlr-18810	73	21	overview	overview	NOUN
ihlr-18810	73	22	/	/	SYM
ihlr-18810	73	23	generalandspecialcontrols	generalandspecialcontrol	NOUN
ihlr-18810	73	24	/	/	SYM
ihlr-18810	73	25	default.htm	default.htm	X
ihlr-18810	73	26	(	(	PUNCT
ihlr-18810	73	27	last	last	ADV
ihlr-18810	73	28	visited	visit	VERB
ihlr-18810	73	29	nov	nov	PROPN
ihlr-18810	73	30	.	.	PROPN
ihlr-18810	73	31	25	25	NUM
ihlr-18810	73	32	,	,	PUNCT
ihlr-18810	73	33	2012	2012	NUM
ihlr-18810	73	34	)	)	PUNCT
ihlr-18810	74	1	[	[	X
ihlr-18810	74	2	hereinafter	hereinafter	NOUN
ihlr-18810	74	3	general	general	ADJ
ihlr-18810	74	4	and	and	CCONJ
ihlr-18810	74	5	special	special	ADJ
ihlr-18810	74	6	controls	control	NOUN
ihlr-18810	74	7	]	]	PUNCT
ihlr-18810	74	8	.	.	PUNCT
ihlr-18810	75	1	2013	2013	NUM
ihlr-18810	75	2	121	121	NUM
ihlr-18810	75	3	indiana	indiana	PROPN
ihlr-18810	75	4	health	health	PROPN
ihlr-18810	75	5	law	law	PROPN
ihlr-18810	75	6	review	review	NOUN
ihlr-18810	75	7	registries	registry	NOUN
ihlr-18810	75	8	,	,	PUNCT
ihlr-18810	75	9	development	development	NOUN
ihlr-18810	75	10	and	and	CCONJ
ihlr-18810	75	11	dissemination	dissemination	NOUN
ihlr-18810	75	12	of	of	ADP
ihlr-18810	75	13	guidelines	guideline	NOUN
ihlr-18810	75	14	"	"	PUNCT
ihlr-18810	75	15	and	and	CCONJ
ihlr-18810	75	16	any	any	DET
ihlr-18810	75	17	other	other	ADJ
ihlr-18810	75	18	actions	action	NOUN
ihlr-18810	75	19	deemed	deem	VERB
ihlr-18810	75	20	appropriate	appropriate	ADJ
ihlr-18810	75	21	by	by	ADP
ihlr-18810	75	22	the	the	DET
ihlr-18810	75	23	secretary	secretary	PROPN
ihlr-18810	75	24	of	of	ADP
ihlr-18810	75	25	the	the	DET
ihlr-18810	75	26	department	department	PROPN
ihlr-18810	75	27	of	of	ADP
ihlr-18810	75	28	health	health	PROPN
ihlr-18810	75	29	and	and	CCONJ
ihlr-18810	75	30	human	human	PROPN
ihlr-18810	75	31	services.18	services.18	PROPN
ihlr-18810	75	32	examples	example	NOUN
ihlr-18810	75	33	of	of	ADP
ihlr-18810	75	34	class	class	NOUN
ihlr-18810	75	35	ii	ii	PROPN
ihlr-18810	75	36	devices	device	NOUN
ihlr-18810	75	37	include	include	VERB
ihlr-18810	75	38	surgical	surgical	ADJ
ihlr-18810	75	39	drapes	drape	NOUN
ihlr-18810	75	40	,	,	PUNCT
ihlr-18810	75	41	powered	power	VERB
ihlr-18810	75	42	wheel	wheel	NOUN
ihlr-18810	75	43	chairs	chair	NOUN
ihlr-18810	75	44	,	,	PUNCT
ihlr-18810	75	45	'	'	PUNCT
ihlr-18810	75	46	9	9	NUM
ihlr-18810	75	47	and	and	CCONJ
ihlr-18810	75	48	tampons.20	tampons.20	PROPN
ihlr-18810	75	49	the	the	DET
ihlr-18810	75	50	last	last	ADJ
ihlr-18810	75	51	class	class	NOUN
ihlr-18810	75	52	of	of	ADP
ihlr-18810	75	53	devices	device	NOUN
ihlr-18810	75	54	,	,	PUNCT
ihlr-18810	75	55	class	class	NOUN
ihlr-18810	75	56	iii	iii	PROPN
ihlr-18810	75	57	,	,	PUNCT
ihlr-18810	75	58	are	be	AUX
ihlr-18810	75	59	those	those	PRON
ihlr-18810	75	60	that	that	PRON
ihlr-18810	75	61	present	present	VERB
ihlr-18810	75	62	the	the	DET
ihlr-18810	75	63	most	most	ADJ
ihlr-18810	75	64	risk	risk	NOUN
ihlr-18810	75	65	to	to	ADP
ihlr-18810	75	66	patients	patient	NOUN
ihlr-18810	75	67	and	and	CCONJ
ihlr-18810	75	68	are	be	AUX
ihlr-18810	75	69	intended	intend	VERB
ihlr-18810	75	70	for	for	ADP
ihlr-18810	75	71	use	use	NOUN
ihlr-18810	75	72	in	in	ADP
ihlr-18810	75	73	supporting	support	VERB
ihlr-18810	75	74	or	or	CCONJ
ihlr-18810	75	75	sustaining	sustain	VERB
ihlr-18810	75	76	life	life	NOUN
ihlr-18810	75	77	.	.	PUNCT
ihlr-18810	76	1	21	21	NUM
ihlr-18810	76	2	examples	example	NOUN
ihlr-18810	76	3	of	of	ADP
ihlr-18810	76	4	class	class	NOUN
ihlr-18810	76	5	iii	iii	NOUN
ihlr-18810	76	6	devices	device	NOUN
ihlr-18810	76	7	include	include	VERB
ihlr-18810	76	8	pacemakers	pacemaker	NOUN
ihlr-18810	76	9	,	,	PUNCT
ihlr-18810	76	10	22	22	NUM
ihlr-18810	76	11	orthopedic	orthopedic	ADJ
ihlr-18810	76	12	bone	bone	NOUN
ihlr-18810	76	13	screws	screw	NOUN
ihlr-18810	76	14	,	,	PUNCT
ihlr-18810	76	15	23	23	NUM
ihlr-18810	76	16	and	and	CCONJ
ihlr-18810	76	17	catheters	catheter	NOUN
ihlr-18810	76	18	.	.	PUNCT
ihlr-18810	77	1	24	24	NUM
ihlr-18810	77	2	the	the	DET
ihlr-18810	77	3	fda	fda	PROPN
ihlr-18810	77	4	regulates	regulate	VERB
ihlr-18810	77	5	the	the	DET
ihlr-18810	77	6	manufacture	manufacture	NOUN
ihlr-18810	77	7	of	of	ADP
ihlr-18810	77	8	all	all	DET
ihlr-18810	77	9	devices	device	NOUN
ihlr-18810	77	10	through	through	ADP
ihlr-18810	77	11	what	what	PRON
ihlr-18810	77	12	are	be	AUX
ihlr-18810	77	13	known	know	VERB
ihlr-18810	77	14	as	as	ADP
ihlr-18810	77	15	quality	quality	NOUN
ihlr-18810	77	16	system	system	NOUN
ihlr-18810	77	17	regulations	regulation	NOUN
ihlr-18810	77	18	,	,	PUNCT
ihlr-18810	77	19	current	current	ADJ
ihlr-18810	77	20	good	good	ADJ
ihlr-18810	77	21	manufacturing	manufacturing	NOUN
ihlr-18810	77	22	process	process	NOUN
ihlr-18810	77	23	(	(	PUNCT
ihlr-18810	77	24	gmp	gmp	PROPN
ihlr-18810	77	25	)	)	PUNCT
ihlr-18810	77	26	requirements	requirement	NOUN
ihlr-18810	77	27	,	,	PUNCT
ihlr-18810	77	28	postmarket	postmarket	ADJ
ihlr-18810	77	29	surveillance	surveillance	NOUN
ihlr-18810	77	30	,	,	PUNCT
ihlr-18810	77	31	and	and	CCONJ
ihlr-18810	77	32	adverse	adverse	ADJ
ihlr-18810	77	33	experience	experience	NOUN
ihlr-18810	77	34	reporting	reporting	NOUN
ihlr-18810	77	35	.	.	PUNCT
ihlr-18810	78	1	25	25	NUM
ihlr-18810	78	2	these	these	DET
ihlr-18810	78	3	regulations	regulation	NOUN
ihlr-18810	78	4	require	require	VERB
ihlr-18810	78	5	the	the	DET
ihlr-18810	78	6	manufacturer	manufacturer	NOUN
ihlr-18810	78	7	of	of	ADP
ihlr-18810	78	8	the	the	DET
ihlr-18810	78	9	device	device	NOUN
ihlr-18810	78	10	to	to	PART
ihlr-18810	78	11	establish	establish	VERB
ihlr-18810	78	12	and	and	CCONJ
ihlr-18810	78	13	maintain	maintain	VERB
ihlr-18810	78	14	procedures	procedure	NOUN
ihlr-18810	78	15	able	able	ADJ
ihlr-18810	78	16	to	to	PART
ihlr-18810	78	17	prevent	prevent	VERB
ihlr-18810	78	18	contamination	contamination	NOUN
ihlr-18810	78	19	of	of	ADP
ihlr-18810	78	20	the	the	DET
ihlr-18810	78	21	equipment	equipment	NOUN
ihlr-18810	78	22	and	and	CCONJ
ihlr-18810	78	23	products	product	NOUN
ihlr-18810	78	24	by	by	ADP
ihlr-18810	78	25	sub	sub	NOUN
ihlr-18810	78	26	-	-	NOUN
ihlr-18810	78	27	stances	stance	NOUN
ihlr-18810	78	28	that	that	PRON
ihlr-18810	78	29	could	could	AUX
ihlr-18810	78	30	have	have	VERB
ihlr-18810	78	31	an	an	DET
ihlr-18810	78	32	adverse	adverse	ADJ
ihlr-18810	78	33	effect	effect	NOUN
ihlr-18810	78	34	on	on	ADP
ihlr-18810	78	35	device	device	NOUN
ihlr-18810	78	36	quality	quality	NOUN
ihlr-18810	78	37	and	and	CCONJ
ihlr-18810	78	38	safety	safety	NOUN
ihlr-18810	78	39	.	.	PUNCT
ihlr-18810	79	1	26	26	NUM
ihlr-18810	79	2	additionally	additionally	ADV
ihlr-18810	79	3	,	,	PUNCT
ihlr-18810	79	4	each	each	DET
ihlr-18810	79	5	manufacturer	manufacturer	NOUN
ihlr-18810	79	6	must	must	AUX
ihlr-18810	79	7	also	also	ADV
ihlr-18810	79	8	implement	implement	VERB
ihlr-18810	79	9	processes	process	NOUN
ihlr-18810	79	10	to	to	PART
ihlr-18810	79	11	test	test	VERB
ihlr-18810	79	12	the	the	DET
ihlr-18810	79	13	products	product	NOUN
ihlr-18810	79	14	for	for	ADP
ihlr-18810	79	15	compliance	compliance	NOUN
ihlr-18810	79	16	with	with	ADP
ihlr-18810	79	17	the	the	DET
ihlr-18810	79	18	product	product	NOUN
ihlr-18810	79	19	specifications	specification	NOUN
ihlr-18810	79	20	(	(	PUNCT
ihlr-18810	79	21	established	establish	VERB
ihlr-18810	79	22	and	and	CCONJ
ihlr-18810	79	23	maintained	maintain	VERB
ihlr-18810	79	24	by	by	ADP
ihlr-18810	79	25	the	the	DET
ihlr-18810	79	26	manufacturer	manufacturer	NOUN
ihlr-18810	79	27	,	,	PUNCT
ihlr-18810	79	28	subject	subject	ADJ
ihlr-18810	79	29	to	to	ADP
ihlr-18810	79	30	verification	verification	NOUN
ihlr-18810	79	31	and/or	and/or	CCONJ
ihlr-18810	79	32	validation	validation	NOUN
ihlr-18810	79	33	by	by	ADP
ihlr-18810	79	34	the	the	DET
ihlr-18810	79	35	fda	fda	PROPN
ihlr-18810	79	36	as	as	ADV
ihlr-18810	79	37	appropriate	appropriate	ADJ
ihlr-18810	79	38	to	to	PART
ihlr-18810	79	39	ensure	ensure	VERB
ihlr-18810	79	40	device	device	NOUN
ihlr-18810	79	41	safety27	safety27	NOUN
ihlr-18810	79	42	)	)	PUNCT
ihlr-18810	79	43	,	,	PUNCT
ihlr-18810	79	44	to	to	PART
ihlr-18810	79	45	identify	identify	VERB
ihlr-18810	79	46	and	and	CCONJ
ihlr-18810	79	47	control	control	VERB
ihlr-18810	79	48	nonconforming	nonconforming	NOUN
ihlr-18810	79	49	products	product	NOUN
ihlr-18810	79	50	,	,	PUNCT
ihlr-18810	79	51	and	and	CCONJ
ihlr-18810	79	52	to	to	PART
ihlr-18810	79	53	document	document	VERB
ihlr-18810	79	54	such	such	ADJ
ihlr-18810	79	55	compliance	compliance	NOUN
ihlr-18810	79	56	before	before	SCONJ
ihlr-18810	79	57	the	the	DET
ihlr-18810	79	58	products	product	NOUN
ihlr-18810	79	59	are	be	AUX
ihlr-18810	79	60	sold	sell	VERB
ihlr-18810	79	61	or	or	CCONJ
ihlr-18810	79	62	used.28	used.28	PROPN
ihlr-18810	79	63	class	class	NOUN
ihlr-18810	79	64	i	i	PROPN
ihlr-18810	79	65	and	and	CCONJ
ihlr-18810	79	66	class	class	NOUN
ihlr-18810	79	67	ii	ii	NOUN
ihlr-18810	79	68	devices	device	NOUN
ihlr-18810	79	69	,	,	PUNCT
ihlr-18810	79	70	because	because	SCONJ
ihlr-18810	79	71	they	they	PRON
ihlr-18810	79	72	present	present	VERB
ihlr-18810	79	73	little	little	ADJ
ihlr-18810	79	74	risk	risk	NOUN
ihlr-18810	79	75	of	of	ADP
ihlr-18810	79	76	illness	illness	NOUN
ihlr-18810	79	77	or	or	CCONJ
ihlr-18810	79	78	injury	injury	NOUN
ihlr-18810	79	79	,	,	PUNCT
ihlr-18810	79	80	are	be	AUX
ihlr-18810	79	81	subject	subject	ADJ
ihlr-18810	79	82	to	to	ADP
ihlr-18810	79	83	only	only	ADV
ihlr-18810	79	84	these	these	DET
ihlr-18810	79	85	general	general	ADJ
ihlr-18810	79	86	regulatory	regulatory	ADJ
ihlr-18810	79	87	controls	control	NOUN
ihlr-18810	79	88	of	of	ADP
ihlr-18810	79	89	safety	safety	NOUN
ihlr-18810	79	90	and	and	CCONJ
ihlr-18810	79	91	18	18	NUM
ihlr-18810	79	92	21	21	NUM
ihlr-18810	79	93	u.s.c	u.s.c	NOUN
ihlr-18810	79	94	.	.	PUNCT
ihlr-18810	80	1	§	§	PROPN
ihlr-18810	80	2	360c(a)(1)(b	360c(a)(1)(b	PROPN
ihlr-18810	80	3	)	)	PUNCT
ihlr-18810	80	4	(	(	PUNCT
ihlr-18810	80	5	2012	2012	NUM
ihlr-18810	80	6	)	)	PUNCT
ihlr-18810	80	7	.	.	PUNCT
ihlr-18810	81	1	19	19	NUM
ihlr-18810	81	2	general	general	ADJ
ihlr-18810	81	3	and	and	CCONJ
ihlr-18810	81	4	special	special	ADJ
ihlr-18810	81	5	controls	control	NOUN
ihlr-18810	81	6	,	,	PUNCT
ihlr-18810	81	7	supra	supra	PROPN
ihlr-18810	81	8	note	note	NOUN
ihlr-18810	81	9	17	17	NUM
ihlr-18810	81	10	.	.	SYM
ihlr-18810	81	11	20	20	NUM
ihlr-18810	81	12	nat'l	nat'l	PROPN
ihlr-18810	81	13	bank	bank	PROPN
ihlr-18810	81	14	of	of	ADP
ihlr-18810	81	15	commerce	commerce	PROPN
ihlr-18810	81	16	v.	v.	ADP
ihlr-18810	81	17	kimberly	kimberly	PROPN
ihlr-18810	81	18	-	-	PUNCT
ihlr-18810	81	19	clark	clark	PROPN
ihlr-18810	81	20	corp	corp	PROPN
ihlr-18810	81	21	.	.	PROPN
ihlr-18810	81	22	,	,	PUNCT
ihlr-18810	81	23	38	38	NUM
ihlr-18810	81	24	f.3d	f.3d	NUM
ihlr-18810	81	25	988	988	NUM
ihlr-18810	81	26	,	,	PUNCT
ihlr-18810	81	27	990	990	NUM
ihlr-18810	81	28	(	(	PUNCT
ihlr-18810	81	29	8th	8th	ADJ
ihlr-18810	81	30	cir	cir	NOUN
ihlr-18810	81	31	.	.	PROPN
ihlr-18810	81	32	1994	1994	NUM
ihlr-18810	81	33	)	)	PUNCT
ihlr-18810	81	34	(	(	PUNCT
ihlr-18810	81	35	citing	cite	VERB
ihlr-18810	81	36	21	21	NUM
ihlr-18810	81	37	c.f.r	c.f.r	NOUN
ihlr-18810	81	38	.	.	PUNCT
ihlr-18810	82	1	§	§	PROPN
ihlr-18810	82	2	§	§	PROPN
ihlr-18810	82	3	884.5460	884.5460	NUM
ihlr-18810	82	4	,	,	PUNCT
ihlr-18810	82	5	884.5470	884.5470	NUM
ihlr-18810	82	6	(	(	PUNCT
ihlr-18810	82	7	2012	2012	NUM
ihlr-18810	82	8	)	)	PUNCT
ihlr-18810	82	9	)	)	PUNCT
ihlr-18810	82	10	.	.	PUNCT
ihlr-18810	83	1	21	21	NUM
ihlr-18810	83	2	21	21	NUM
ihlr-18810	83	3	u.s.c	u.s.c	NOUN
ihlr-18810	83	4	.	.	PUNCT
ihlr-18810	84	1	§	§	PROPN
ihlr-18810	84	2	360c(a)(1)(c	360c(a)(1)(c	NUM
ihlr-18810	84	3	)	)	PUNCT
ihlr-18810	84	4	(	(	PUNCT
ihlr-18810	84	5	2012	2012	NUM
ihlr-18810	84	6	)	)	PUNCT
ihlr-18810	84	7	.	.	PUNCT
ihlr-18810	85	1	22	22	NUM
ihlr-18810	85	2	general	general	ADJ
ihlr-18810	85	3	and	and	CCONJ
ihlr-18810	85	4	special	special	ADJ
ihlr-18810	85	5	controls	control	NOUN
ihlr-18810	85	6	,	,	PUNCT
ihlr-18810	85	7	supra	supra	PROPN
ihlr-18810	85	8	note	note	NOUN
ihlr-18810	85	9	17	17	NUM
ihlr-18810	85	10	.	.	PUNCT
ihlr-18810	85	11	23	23	NUM
ihlr-18810	85	12	buckman	buckman	PROPN
ihlr-18810	85	13	co.	co.	PROPN
ihlr-18810	85	14	v.	v.	ADP
ihlr-18810	85	15	plaintiffs	plaintiffs	PROPN
ihlr-18810	85	16	legal	legal	ADJ
ihlr-18810	85	17	comm	comm	NOUN
ihlr-18810	85	18	.	.	PUNCT
ihlr-18810	85	19	,	,	PUNCT
ihlr-18810	85	20	531	531	NUM
ihlr-18810	85	21	u.s	u.s	PROPN
ihlr-18810	85	22	.	.	PROPN
ihlr-18810	85	23	341	341	NUM
ihlr-18810	85	24	,	,	PUNCT
ihlr-18810	85	25	344	344	NUM
ihlr-18810	85	26	(	(	PUNCT
ihlr-18810	85	27	2001	2001	NUM
ihlr-18810	85	28	)	)	PUNCT
ihlr-18810	85	29	.	.	PUNCT
ihlr-18810	86	1	24	24	NUM
ihlr-18810	86	2	riegel	riegel	PROPN
ihlr-18810	86	3	v.	v.	PROPN
ihlr-18810	86	4	medtronic	medtronic	PROPN
ihlr-18810	86	5	,	,	PUNCT
ihlr-18810	86	6	inc	inc	PROPN
ihlr-18810	86	7	.	.	PROPN
ihlr-18810	86	8	,	,	PUNCT
ihlr-18810	86	9	552	552	NUM
ihlr-18810	86	10	u.s	u.s	PROPN
ihlr-18810	86	11	.	.	PROPN
ihlr-18810	86	12	312	312	NUM
ihlr-18810	86	13	,	,	PUNCT
ihlr-18810	86	14	320	320	NUM
ihlr-18810	86	15	(	(	PUNCT
ihlr-18810	86	16	2008	2008	NUM
ihlr-18810	86	17	)	)	PUNCT
ihlr-18810	86	18	.	.	PUNCT
ihlr-18810	87	1	25	25	NUM
ihlr-18810	87	2	general	general	ADJ
ihlr-18810	87	3	and	and	CCONJ
ihlr-18810	87	4	special	special	ADJ
ihlr-18810	87	5	controls	control	NOUN
ihlr-18810	87	6	,	,	PUNCT
ihlr-18810	87	7	supra	supra	PROPN
ihlr-18810	87	8	note	note	NOUN
ihlr-18810	87	9	17	17	NUM
ihlr-18810	87	10	.	.	NOUN
ihlr-18810	87	11	26	26	NUM
ihlr-18810	87	12	21	21	NUM
ihlr-18810	87	13	c.f.r	c.f.r	NOUN
ihlr-18810	87	14	.	.	PUNCT
ihlr-18810	88	1	§	§	PROPN
ihlr-18810	88	2	820.70(e	820.70(e	PROPN
ihlr-18810	88	3	)	)	PUNCT
ihlr-18810	88	4	(	(	PUNCT
ihlr-18810	88	5	2012	2012	NUM
ihlr-18810	88	6	)	)	PUNCT
ihlr-18810	88	7	.	.	PUNCT
ihlr-18810	89	1	27	27	NUM
ihlr-18810	89	2	21	21	NUM
ihlr-18810	89	3	c.f.r	c.f.r	NOUN
ihlr-18810	89	4	.	.	PUNCT
ihlr-18810	90	1	§	§	PROPN
ihlr-18810	90	2	820.70(b	820.70(b	PROPN
ihlr-18810	90	3	)	)	PUNCT
ihlr-18810	90	4	(	(	PUNCT
ihlr-18810	90	5	2012	2012	NUM
ihlr-18810	90	6	)	)	PUNCT
ihlr-18810	90	7	.	.	PUNCT
ihlr-18810	91	1	28	28	NUM
ihlr-18810	91	2	21	21	NUM
ihlr-18810	91	3	c.f.r	c.f.r	NOUN
ihlr-18810	91	4	.	.	PUNCT
ihlr-18810	92	1	§	§	PROPN
ihlr-18810	92	2	§	§	PROPN
ihlr-18810	92	3	820.72	820.72	NUM
ihlr-18810	92	4	-	-	SYM
ihlr-18810	92	5	820.90	820.90	NUM
ihlr-18810	92	6	(	(	PUNCT
ihlr-18810	92	7	2012	2012	NUM
ihlr-18810	92	8	)	)	PUNCT
ihlr-18810	92	9	.	.	PUNCT
ihlr-18810	93	1	vol	vol	NOUN
ihlr-18810	93	2	.	.	PUNCT
ihlr-18810	93	3	10:1122	10:1122	NUM
ihlr-18810	94	1	510(k	510(k	NUM
ihlr-18810	94	2	)	)	PUNCT
ihlr-18810	94	3	clearance	clearance	NOUN
ihlr-18810	94	4	effectiveness	effectiveness	NOUN
ihlr-18810	94	5	.	.	PUNCT
ihlr-18810	95	1	29	29	NUM
ihlr-18810	95	2	consequently	consequently	ADV
ihlr-18810	95	3	,	,	PUNCT
ihlr-18810	95	4	there	there	PRON
ihlr-18810	95	5	are	be	VERB
ihlr-18810	95	6	no	no	DET
ihlr-18810	95	7	federal	federal	ADJ
ihlr-18810	95	8	regulations	regulation	NOUN
ihlr-18810	95	9	of	of	ADP
ihlr-18810	95	10	design	design	NOUN
ihlr-18810	95	11	or	or	CCONJ
ihlr-18810	95	12	manufacture	manufacture	NOUN
ihlr-18810	95	13	for	for	ADP
ihlr-18810	95	14	class	class	NOUN
ihlr-18810	95	15	i	i	PROPN
ihlr-18810	95	16	or	or	CCONJ
ihlr-18810	95	17	ii	ii	PROPN
ihlr-18810	95	18	devices.30	devices.30	PROPN
ihlr-18810	95	19	class	class	PROPN
ihlr-18810	95	20	iii	iii	PROPN
ihlr-18810	95	21	devices	device	NOUN
ihlr-18810	95	22	are	be	AUX
ihlr-18810	95	23	treated	treat	VERB
ihlr-18810	95	24	quite	quite	ADV
ihlr-18810	95	25	differently	differently	ADV
ihlr-18810	95	26	,	,	PUNCT
ihlr-18810	95	27	however	however	ADV
ihlr-18810	95	28	,	,	PUNCT
ihlr-18810	95	29	and	and	CCONJ
ihlr-18810	95	30	require	require	VERB
ihlr-18810	95	31	extensive	extensive	ADJ
ihlr-18810	95	32	evaluation	evaluation	NOUN
ihlr-18810	95	33	and	and	CCONJ
ihlr-18810	95	34	approval	approval	NOUN
ihlr-18810	95	35	of	of	ADP
ihlr-18810	95	36	their	their	PRON
ihlr-18810	95	37	safety	safety	NOUN
ihlr-18810	95	38	and	and	CCONJ
ihlr-18810	95	39	efficacy	efficacy	NOUN
ihlr-18810	95	40	,	,	PUNCT
ihlr-18810	95	41	while	while	SCONJ
ihlr-18810	95	42	also	also	ADV
ihlr-18810	95	43	being	be	AUX
ihlr-18810	95	44	subject	subject	ADJ
ihlr-18810	95	45	to	to	ADP
ihlr-18810	95	46	the	the	DET
ihlr-18810	95	47	same	same	ADJ
ihlr-18810	95	48	general	general	ADJ
ihlr-18810	95	49	regulatory	regulatory	ADJ
ihlr-18810	95	50	controls	control	NOUN
ihlr-18810	95	51	.	.	PUNCT
ihlr-18810	96	1	the	the	DET
ihlr-18810	96	2	mda	mda	PROPN
ihlr-18810	96	3	provided	provide	VERB
ihlr-18810	96	4	that	that	SCONJ
ihlr-18810	96	5	all	all	DET
ihlr-18810	96	6	post	post	PROPN
ihlr-18810	96	7	amendment	amendment	NOUN
ihlr-18810	96	8	devices	device	NOUN
ihlr-18810	96	9	were	be	AUX
ihlr-18810	96	10	to	to	PART
ihlr-18810	96	11	be	be	AUX
ihlr-18810	96	12	automatically	automatically	ADV
ihlr-18810	96	13	classified	classify	VERB
ihlr-18810	96	14	as	as	ADP
ihlr-18810	96	15	class	class	NOUN
ihlr-18810	96	16	iii	iii	NOUN
ihlr-18810	96	17	,	,	PUNCT
ihlr-18810	96	18	unless	unless	SCONJ
ihlr-18810	96	19	they	they	PRON
ihlr-18810	96	20	met	meet	VERB
ihlr-18810	96	21	a	a	DET
ihlr-18810	96	22	specific	specific	ADJ
ihlr-18810	96	23	exception.3	exception.3	NOUN
ihlr-18810	96	24	'	'	PUNCT
ihlr-18810	96	25	class	class	NOUN
ihlr-18810	96	26	iii	iii	NOUN
ihlr-18810	96	27	devices	device	NOUN
ihlr-18810	96	28	are	be	AUX
ihlr-18810	96	29	required	require	VERB
ihlr-18810	96	30	to	to	PART
ihlr-18810	96	31	undergo	undergo	VERB
ihlr-18810	96	32	a	a	DET
ihlr-18810	96	33	process	process	NOUN
ihlr-18810	96	34	of	of	ADP
ihlr-18810	96	35	scientific	scientific	ADJ
ihlr-18810	96	36	review	review	NOUN
ihlr-18810	96	37	to	to	PART
ihlr-18810	96	38	ensure	ensure	VERB
ihlr-18810	96	39	their	their	PRON
ihlr-18810	96	40	safety	safety	NOUN
ihlr-18810	96	41	and	and	CCONJ
ihlr-18810	96	42	effectiveness	effectiveness	NOUN
ihlr-18810	96	43	before	before	SCONJ
ihlr-18810	96	44	they	they	PRON
ihlr-18810	96	45	are	be	AUX
ihlr-18810	96	46	permitted	permit	VERB
ihlr-18810	96	47	to	to	PART
ihlr-18810	96	48	be	be	AUX
ihlr-18810	96	49	marketed	market	VERB
ihlr-18810	96	50	,	,	PUNCT
ihlr-18810	96	51	known	know	VERB
ihlr-18810	96	52	as	as	ADP
ihlr-18810	96	53	premarket	premarket	NOUN
ihlr-18810	96	54	approval	approval	NOUN
ihlr-18810	96	55	(	(	PUNCT
ihlr-18810	96	56	pma).32	pma).32	SCONJ
ihlr-18810	96	57	the	the	DET
ihlr-18810	96	58	application	application	NOUN
ihlr-18810	96	59	for	for	ADP
ihlr-18810	96	60	plvia	plvia	NOUN
ihlr-18810	96	61	is	be	AUX
ihlr-18810	96	62	lengthy	lengthy	ADJ
ihlr-18810	96	63	,	,	PUNCT
ihlr-18810	96	64	and	and	CCONJ
ihlr-18810	96	65	manufacturers	manufacturer	NOUN
ihlr-18810	96	66	must	must	AUX
ihlr-18810	96	67	submit	submit	VERB
ihlr-18810	96	68	detailed	detailed	ADJ
ihlr-18810	96	69	information	information	NOUN
ihlr-18810	96	70	regarding	regard	VERB
ihlr-18810	96	71	the	the	DET
ihlr-18810	96	72	safety	safety	NOUN
ihlr-18810	96	73	and	and	CCONJ
ihlr-18810	96	74	efficacy	efficacy	NOUN
ihlr-18810	96	75	of	of	ADP
ihlr-18810	96	76	their	their	PRON
ihlr-18810	96	77	devices	device	NOUN
ihlr-18810	96	78	.	.	PUNCT
ihlr-18810	97	1	specifically	specifically	ADV
ihlr-18810	97	2	,	,	PUNCT
ihlr-18810	97	3	the	the	DET
ihlr-18810	97	4	fda	fda	PROPN
ihlr-18810	97	5	requires	require	VERB
ihlr-18810	97	6	that	that	SCONJ
ihlr-18810	97	7	the	the	DET
ihlr-18810	97	8	applicant	applicant	ADJ
ihlr-18810	97	9	document	document	NOUN
ihlr-18810	97	10	descriptions	description	NOUN
ihlr-18810	97	11	,	,	PUNCT
ihlr-18810	97	12	investigations	investigation	NOUN
ihlr-18810	97	13	,	,	PUNCT
ihlr-18810	97	14	and	and	CCONJ
ihlr-18810	97	15	other	other	ADJ
ihlr-18810	97	16	relevant	relevant	ADJ
ihlr-18810	97	17	information	information	NOUN
ihlr-18810	97	18	pertaining	pertain	VERB
ihlr-18810	97	19	to	to	ADP
ihlr-18810	97	20	the	the	DET
ihlr-18810	97	21	safety	safety	NOUN
ihlr-18810	97	22	and	and	CCONJ
ihlr-18810	97	23	efficacy	efficacy	NOUN
ihlr-18810	97	24	of	of	ADP
ihlr-18810	97	25	the	the	DET
ihlr-18810	97	26	device	device	NOUN
ihlr-18810	97	27	for	for	ADP
ihlr-18810	97	28	which	which	PRON
ihlr-18810	97	29	approval	approval	NOUN
ihlr-18810	97	30	is	be	AUX
ihlr-18810	97	31	sought.33	sought.33	PROPN
ihlr-18810	97	32	the	the	DET
ihlr-18810	97	33	application	application	NOUN
ihlr-18810	97	34	must	must	AUX
ihlr-18810	97	35	include	include	VERB
ihlr-18810	97	36	a	a	DET
ihlr-18810	97	37	full	full	ADJ
ihlr-18810	97	38	description	description	NOUN
ihlr-18810	97	39	of	of	ADP
ihlr-18810	97	40	the	the	DET
ihlr-18810	97	41	device	device	NOUN
ihlr-18810	97	42	,	,	PUNCT
ihlr-18810	97	43	its	its	PRON
ihlr-18810	97	44	components	component	NOUN
ihlr-18810	97	45	,	,	PUNCT
ihlr-18810	97	46	how	how	SCONJ
ihlr-18810	97	47	it	it	PRON
ihlr-18810	97	48	works	work	VERB
ihlr-18810	97	49	,	,	PUNCT
ihlr-18810	97	50	and	and	CCONJ
ihlr-18810	97	51	its	its	PRON
ihlr-18810	97	52	indications	indication	NOUN
ihlr-18810	97	53	for	for	ADP
ihlr-18810	97	54	use	use	NOUN
ihlr-18810	97	55	,	,	PUNCT
ihlr-18810	97	56	as	as	ADV
ihlr-18810	97	57	well	well	ADV
ihlr-18810	97	58	as	as	ADP
ihlr-18810	97	59	the	the	DET
ihlr-18810	97	60	methods	method	NOUN
ihlr-18810	97	61	used	use	VERB
ihlr-18810	97	62	in	in	ADP
ihlr-18810	97	63	the	the	DET
ihlr-18810	97	64	manufacture	manufacture	NOUN
ihlr-18810	97	65	,	,	PUNCT
ihlr-18810	97	66	processing	processing	NOUN
ihlr-18810	97	67	,	,	PUNCT
ihlr-18810	97	68	packaging	packaging	NOUN
ihlr-18810	97	69	,	,	PUNCT
ihlr-18810	97	70	and	and	CCONJ
ihlr-18810	97	71	installation	installation	NOUN
ihlr-18810	97	72	of	of	ADP
ihlr-18810	97	73	the	the	DET
ihlr-18810	97	74	device	device	NOUN
ihlr-18810	97	75	.	.	PUNCT
ihlr-18810	98	1	34	34	NUM
ihlr-18810	98	2	additionally	additionally	ADV
ihlr-18810	98	3	,	,	PUNCT
ihlr-18810	98	4	information	information	NOUN
ihlr-18810	98	5	regarding	regard	VERB
ihlr-18810	98	6	the	the	DET
ihlr-18810	98	7	proposed	propose	VERB
ihlr-18810	98	8	labeling	labeling	NOUN
ihlr-18810	98	9	,	,	PUNCT
ihlr-18810	98	10	investigations	investigation	NOUN
ihlr-18810	98	11	,	,	PUNCT
ihlr-18810	98	12	and	and	CCONJ
ihlr-18810	98	13	directions	direction	NOUN
ihlr-18810	98	14	for	for	ADP
ihlr-18810	98	15	use	use	NOUN
ihlr-18810	98	16	must	must	AUX
ihlr-18810	98	17	also	also	ADV
ihlr-18810	98	18	be	be	AUX
ihlr-18810	98	19	included.35	included.35	NOUN
ihlr-18810	98	20	a	a	DET
ihlr-18810	98	21	pia	pia	NOUN
ihlr-18810	98	22	,	,	PUNCT
ihlr-18810	98	23	if	if	SCONJ
ihlr-18810	98	24	granted	grant	VERB
ihlr-18810	98	25	,	,	PUNCT
ihlr-18810	98	26	will	will	AUX
ihlr-18810	98	27	be	be	AUX
ihlr-18810	98	28	based	base	VERB
ihlr-18810	98	29	on	on	ADP
ihlr-18810	98	30	29	29	NUM
ihlr-18810	98	31	21	21	NUM
ihlr-18810	98	32	u.s.c	u.s.c	NOUN
ihlr-18810	98	33	.	.	PUNCT
ihlr-18810	99	1	§	§	PROPN
ihlr-18810	99	2	360c(a)(1)(a)(ii)(ii	360c(a)(1)(a)(ii)(ii	NUM
ihlr-18810	99	3	)	)	PUNCT
ihlr-18810	99	4	(	(	PUNCT
ihlr-18810	99	5	2012	2012	NUM
ihlr-18810	99	6	)	)	PUNCT
ihlr-18810	99	7	.	.	PUNCT
ihlr-18810	100	1	30	30	NUM
ihlr-18810	100	2	as	as	ADP
ihlr-18810	100	3	a	a	DET
ihlr-18810	100	4	general	general	ADJ
ihlr-18810	100	5	matter	matter	NOUN
ihlr-18810	100	6	,	,	PUNCT
ihlr-18810	100	7	the	the	DET
ihlr-18810	100	8	fda	fda	PROPN
ihlr-18810	100	9	does	do	AUX
ihlr-18810	100	10	have	have	AUX
ihlr-18810	100	11	the	the	DET
ihlr-18810	100	12	authority	authority	NOUN
ihlr-18810	100	13	to	to	PART
ihlr-18810	100	14	impose	impose	VERB
ihlr-18810	100	15	specific	specific	ADJ
ihlr-18810	100	16	regulations	regulation	NOUN
ihlr-18810	100	17	pertaining	pertain	VERB
ihlr-18810	100	18	to	to	PART
ihlr-18810	100	19	manufacture	manufacture	VERB
ihlr-18810	100	20	or	or	CCONJ
ihlr-18810	100	21	labeling	labeling	NOUN
ihlr-18810	100	22	,	,	PUNCT
ihlr-18810	100	23	instruction	instruction	NOUN
ihlr-18810	100	24	or	or	CCONJ
ihlr-18810	100	25	warning	warning	NOUN
ihlr-18810	100	26	if	if	SCONJ
ihlr-18810	100	27	it	it	PRON
ihlr-18810	100	28	determines	determine	VERB
ihlr-18810	100	29	the	the	DET
ihlr-18810	100	30	safe	safe	ADJ
ihlr-18810	100	31	use	use	NOUN
ihlr-18810	100	32	of	of	ADP
ihlr-18810	100	33	a	a	DET
ihlr-18810	100	34	class	class	NOUN
ihlr-18810	100	35	i	i	PRON
ihlr-18810	100	36	or	or	CCONJ
ihlr-18810	100	37	ii	ii	PROPN
ihlr-18810	100	38	device	device	NOUN
ihlr-18810	100	39	requires	require	VERB
ihlr-18810	100	40	it	it	PRON
ihlr-18810	100	41	.	.	PUNCT
ihlr-18810	101	1	see	see	VERB
ihlr-18810	101	2	section	section	NOUN
ihlr-18810	101	3	ii(b)(1	ii(b)(1	NOUN
ihlr-18810	101	4	)	)	PUNCT
ihlr-18810	101	5	below	below	ADP
ihlr-18810	101	6	for	for	ADP
ihlr-18810	101	7	a	a	DET
ihlr-18810	101	8	discussion	discussion	NOUN
ihlr-18810	101	9	on	on	ADP
ihlr-18810	101	10	these	these	DET
ihlr-18810	101	11	regulations	regulation	NOUN
ihlr-18810	101	12	.	.	PUNCT
ihlr-18810	102	1	see	see	VERB
ihlr-18810	102	2	also	also	ADV
ihlr-18810	102	3	,	,	PUNCT
ihlr-18810	102	4	e.g.	e.g.	ADV
ihlr-18810	102	5	,	,	PUNCT
ihlr-18810	102	6	21	21	NUM
ihlr-18810	102	7	c.f.r	c.f.r	NOUN
ihlr-18810	102	8	.	.	PUNCT
ihlr-18810	103	1	§	§	PROPN
ihlr-18810	103	2	801.430	801.430	NUM
ihlr-18810	103	3	(	(	PUNCT
ihlr-18810	103	4	2012	2012	NUM
ihlr-18810	103	5	)	)	PUNCT
ihlr-18810	103	6	(	(	PUNCT
ihlr-18810	103	7	warning	warn	VERB
ihlr-18810	103	8	requirements	requirement	NOUN
ihlr-18810	103	9	for	for	ADP
ihlr-18810	103	10	tampons	tampon	NOUN
ihlr-18810	103	11	)	)	PUNCT
ihlr-18810	103	12	.	.	PUNCT
ihlr-18810	104	1	31	31	NUM
ihlr-18810	104	2	iom	iom	PROPN
ihlr-18810	104	3	report	report	NOUN
ihlr-18810	104	4	,	,	PUNCT
ihlr-18810	104	5	supra	supra	PROPN
ihlr-18810	104	6	note	note	NOUN
ihlr-18810	104	7	6	6	NUM
ihlr-18810	104	8	,	,	PUNCT
ihlr-18810	104	9	at	at	ADP
ihlr-18810	104	10	86	86	NUM
ihlr-18810	104	11	.	.	PUNCT
ihlr-18810	105	1	devices	device	NOUN
ihlr-18810	105	2	were	be	AUX
ihlr-18810	105	3	not	not	PART
ihlr-18810	105	4	classified	classify	VERB
ihlr-18810	105	5	as	as	ADP
ihlr-18810	105	6	class	class	NOUN
ihlr-18810	105	7	iii	iii	NOUN
ihlr-18810	105	8	if	if	SCONJ
ihlr-18810	105	9	they	they	PRON
ihlr-18810	105	10	were	be	AUX
ihlr-18810	105	11	on	on	ADP
ihlr-18810	105	12	the	the	DET
ihlr-18810	105	13	market	market	NOUN
ihlr-18810	105	14	prior	prior	ADV
ihlr-18810	105	15	to	to	ADP
ihlr-18810	105	16	the	the	DET
ihlr-18810	105	17	enactment	enactment	NOUN
ihlr-18810	105	18	of	of	ADP
ihlr-18810	105	19	the	the	DET
ihlr-18810	105	20	mda	mda	PROPN
ihlr-18810	105	21	or	or	CCONJ
ihlr-18810	105	22	were	be	AUX
ihlr-18810	105	23	substantially	substantially	ADV
ihlr-18810	105	24	equivalent	equivalent	ADJ
ihlr-18810	105	25	to	to	ADP
ihlr-18810	105	26	devices	device	NOUN
ihlr-18810	105	27	on	on	ADP
ihlr-18810	105	28	the	the	DET
ihlr-18810	105	29	market	market	NOUN
ihlr-18810	105	30	at	at	ADP
ihlr-18810	105	31	that	that	DET
ihlr-18810	105	32	time	time	NOUN
ihlr-18810	105	33	,	,	PUNCT
ihlr-18810	105	34	21	21	NUM
ihlr-18810	105	35	u.s.c	u.s.c	ADJ
ihlr-18810	105	36	.	.	PUNCT
ihlr-18810	106	1	§	§	PROPN
ihlr-18810	106	2	360c(f)(1	360c(f)(1	PROPN
ihlr-18810	106	3	)	)	PUNCT
ihlr-18810	106	4	(	(	PUNCT
ihlr-18810	106	5	2012	2012	NUM
ihlr-18810	106	6	)	)	PUNCT
ihlr-18810	106	7	,	,	PUNCT
ihlr-18810	106	8	or	or	CCONJ
ihlr-18810	106	9	the	the	DET
ihlr-18810	106	10	manufacturer	manufacturer	NOUN
ihlr-18810	106	11	of	of	ADP
ihlr-18810	106	12	the	the	DET
ihlr-18810	106	13	device	device	NOUN
ihlr-18810	106	14	may	may	AUX
ihlr-18810	106	15	petition	petition	VERB
ihlr-18810	106	16	for	for	ADP
ihlr-18810	106	17	a	a	DET
ihlr-18810	106	18	reclassification	reclassification	NOUN
ihlr-18810	106	19	of	of	ADP
ihlr-18810	106	20	the	the	DET
ihlr-18810	106	21	device	device	NOUN
ihlr-18810	106	22	to	to	ADP
ihlr-18810	106	23	class	class	NOUN
ihlr-18810	106	24	i	i	PROPN
ihlr-18810	106	25	or	or	CCONJ
ihlr-18810	106	26	ii	ii	PROPN
ihlr-18810	106	27	.	.	PROPN
ihlr-18810	106	28	21	21	NUM
ihlr-18810	106	29	u.s.c	u.s.c	NOUN
ihlr-18810	106	30	.	.	PUNCT
ihlr-18810	107	1	§	§	PROPN
ihlr-18810	107	2	360c(f)(3	360c(f)(3	NUM
ihlr-18810	107	3	)	)	PUNCT
ihlr-18810	107	4	(	(	PUNCT
ihlr-18810	107	5	2012	2012	NUM
ihlr-18810	107	6	)	)	PUNCT
ihlr-18810	107	7	.	.	PUNCT
ihlr-18810	108	1	32	32	NUM
ihlr-18810	108	2	21	21	NUM
ihlr-18810	108	3	u.s.c	u.s.c	NOUN
ihlr-18810	108	4	.	.	PUNCT
ihlr-18810	109	1	§	§	PROPN
ihlr-18810	109	2	360e	360e	PROPN
ihlr-18810	109	3	(	(	PUNCT
ihlr-18810	109	4	2012	2012	NUM
ihlr-18810	109	5	)	)	PUNCT
ihlr-18810	109	6	.	.	PUNCT
ihlr-18810	110	1	33	33	NUM
ihlr-18810	110	2	21	21	NUM
ihlr-18810	110	3	u.s.c	u.s.c	NOUN
ihlr-18810	110	4	.	.	PUNCT
ihlr-18810	111	1	§	§	PROPN
ihlr-18810	111	2	360e(c	360e(c	NUM
ihlr-18810	111	3	)	)	PUNCT
ihlr-18810	111	4	(	(	PUNCT
ihlr-18810	111	5	2012	2012	NUM
ihlr-18810	111	6	)	)	PUNCT
ihlr-18810	111	7	;	;	PUNCT
ihlr-18810	111	8	21	21	NUM
ihlr-18810	111	9	c.f.r	c.f.r	NOUN
ihlr-18810	111	10	.	.	PUNCT
ihlr-18810	112	1	§	§	PROPN
ihlr-18810	112	2	814.20	814.20	NUM
ihlr-18810	112	3	(	(	PUNCT
ihlr-18810	112	4	2012	2012	NUM
ihlr-18810	112	5	)	)	PUNCT
ihlr-18810	112	6	.	.	PUNCT
ihlr-18810	113	1	34	34	NUM
ihlr-18810	113	2	21	21	NUM
ihlr-18810	113	3	u.s.c	u.s.c	NOUN
ihlr-18810	113	4	.	.	PUNCT
ihlr-18810	114	1	§	§	PROPN
ihlr-18810	114	2	360e(c)(1	360e(c)(1	PROPN
ihlr-18810	114	3	)	)	PUNCT
ihlr-18810	114	4	(	(	PUNCT
ihlr-18810	114	5	2012	2012	NUM
ihlr-18810	114	6	)	)	PUNCT
ihlr-18810	114	7	.	.	PUNCT
ihlr-18810	115	1	35	35	NUM
ihlr-18810	115	2	21	21	NUM
ihlr-18810	115	3	u.s.c	u.s.c	NOUN
ihlr-18810	115	4	.	.	PUNCT
ihlr-18810	116	1	§	§	PROPN
ihlr-18810	116	2	360e(c)(2)(a	360e(c)(2)(a	NUM
ihlr-18810	116	3	)	)	PUNCT
ihlr-18810	116	4	(	(	PUNCT
ihlr-18810	116	5	2012	2012	NUM
ihlr-18810	116	6	)	)	PUNCT
ihlr-18810	116	7	.	.	PUNCT
ihlr-18810	117	1	2013	2013	NUM
ihlr-18810	117	2	123	123	NUM
ihlr-18810	117	3	indiana	indiana	PROPN
ihlr-18810	117	4	health	health	PROPN
ihlr-18810	117	5	law	law	NOUN
ihlr-18810	117	6	review	review	NOUN
ihlr-18810	117	7	considerations	consideration	NOUN
ihlr-18810	117	8	of	of	ADP
ihlr-18810	117	9	all	all	PRON
ihlr-18810	117	10	of	of	ADP
ihlr-18810	117	11	this	this	DET
ihlr-18810	117	12	information	information	NOUN
ihlr-18810	117	13	,	,	PUNCT
ihlr-18810	117	14	and	and	CCONJ
ihlr-18810	117	15	may	may	AUX
ihlr-18810	117	16	specify	specify	VERB
ihlr-18810	117	17	requirements	requirement	NOUN
ihlr-18810	117	18	the	the	DET
ihlr-18810	117	19	device	device	NOUN
ihlr-18810	117	20	must	must	AUX
ihlr-18810	117	21	meet	meet	VERB
ihlr-18810	117	22	(	(	PUNCT
ihlr-18810	117	23	based	base	VERB
ihlr-18810	117	24	on	on	ADP
ihlr-18810	117	25	the	the	DET
ihlr-18810	117	26	information	information	NOUN
ihlr-18810	117	27	provided	provide	VERB
ihlr-18810	117	28	,	,	PUNCT
ihlr-18810	117	29	as	as	ADP
ihlr-18810	117	30	relevant	relevant	ADJ
ihlr-18810	117	31	)	)	PUNCT
ihlr-18810	117	32	to	to	PART
ihlr-18810	117	33	be	be	AUX
ihlr-18810	117	34	marketed	market	VERB
ihlr-18810	117	35	.	.	PUNCT
ihlr-18810	118	1	36	36	NUM
ihlr-18810	118	2	the	the	DET
ihlr-18810	118	3	safe	safe	ADJ
ihlr-18810	118	4	medical	medical	ADJ
ihlr-18810	118	5	devices	device	NOUN
ihlr-18810	118	6	act	act	PROPN
ihlr-18810	118	7	of	of	ADP
ihlr-18810	118	8	1990	1990	NUM
ihlr-18810	118	9	gave	give	VERB
ihlr-18810	118	10	the	the	DET
ihlr-18810	118	11	fda	fda	PROPN
ihlr-18810	118	12	the	the	DET
ihlr-18810	118	13	authority	authority	NOUN
ihlr-18810	118	14	to	to	PART
ihlr-18810	118	15	issue	issue	VERB
ihlr-18810	118	16	regulations	regulation	NOUN
ihlr-18810	118	17	which	which	PRON
ihlr-18810	118	18	require	require	VERB
ihlr-18810	118	19	pre	pre	ADJ
ihlr-18810	118	20	-	-	ADJ
ihlr-18810	118	21	production	production	ADJ
ihlr-18810	118	22	design	design	NOUN
ihlr-18810	118	23	controls	control	NOUN
ihlr-18810	118	24	for	for	ADP
ihlr-18810	118	25	medical	medical	ADJ
ihlr-18810	118	26	devices	device	NOUN
ihlr-18810	118	27	,	,	PUNCT
ihlr-18810	118	28	in	in	SCONJ
ihlr-18810	118	29	order	order	NOUN
ihlr-18810	118	30	ensure	ensure	VERB
ihlr-18810	118	31	the	the	DET
ihlr-18810	118	32	safety	safety	NOUN
ihlr-18810	118	33	and	and	CCONJ
ihlr-18810	118	34	efficacy	efficacy	NOUN
ihlr-18810	118	35	of	of	ADP
ihlr-18810	118	36	the	the	DET
ihlr-18810	118	37	device	device	NOUN
ihlr-18810	118	38	.	.	PUNCT
ihlr-18810	119	1	37	37	NUM
ihlr-18810	119	2	a	a	DET
ihlr-18810	119	3	class	class	NOUN
ihlr-18810	119	4	iii	iii	NOUN
ihlr-18810	119	5	device	device	NOUN
ihlr-18810	119	6	that	that	PRON
ihlr-18810	119	7	fails	fail	VERB
ihlr-18810	119	8	to	to	PART
ihlr-18810	119	9	meet	meet	VERB
ihlr-18810	119	10	the	the	DET
ihlr-18810	119	11	requirements	requirement	NOUN
ihlr-18810	119	12	specified	specify	VERB
ihlr-18810	119	13	in	in	ADP
ihlr-18810	119	14	the	the	DET
ihlr-18810	119	15	p1ia	p1ia	NOUN
ihlr-18810	119	16	will	will	AUX
ihlr-18810	119	17	be	be	AUX
ihlr-18810	119	18	considered	consider	VERB
ihlr-18810	119	19	adulterated	adulterate	VERB
ihlr-18810	119	20	under	under	ADP
ihlr-18810	119	21	the	the	DET
ihlr-18810	119	22	fdca	fdca	NOUN
ihlr-18810	119	23	and	and	CCONJ
ihlr-18810	119	24	can	can	AUX
ihlr-18810	119	25	not	not	PART
ihlr-18810	119	26	be	be	AUX
ihlr-18810	119	27	marketed	market	VERB
ihlr-18810	119	28	.	.	PUNCT
ihlr-18810	120	1	38	38	NUM
ihlr-18810	120	2	perhaps	perhaps	ADV
ihlr-18810	120	3	most	most	ADV
ihlr-18810	120	4	importantly	importantly	ADV
ihlr-18810	120	5	,	,	PUNCT
ihlr-18810	120	6	the	the	DET
ihlr-18810	120	7	pma	pma	NOUN
ihlr-18810	120	8	application	application	NOUN
ihlr-18810	120	9	must	must	AUX
ihlr-18810	120	10	include	include	VERB
ihlr-18810	120	11	a	a	DET
ihlr-18810	120	12	summary	summary	NOUN
ihlr-18810	120	13	of	of	ADP
ihlr-18810	120	14	both	both	CCONJ
ihlr-18810	120	15	the	the	DET
ihlr-18810	120	16	nonclinical	nonclinical	ADJ
ihlr-18810	120	17	laboratory	laboratory	NOUN
ihlr-18810	120	18	studies	study	NOUN
ihlr-18810	120	19	and	and	CCONJ
ihlr-18810	120	20	the	the	DET
ihlr-18810	120	21	clinical	clinical	ADJ
ihlr-18810	120	22	studies	study	NOUN
ihlr-18810	120	23	involving	involve	VERB
ihlr-18810	120	24	human	human	ADJ
ihlr-18810	120	25	subjects	subject	NOUN
ihlr-18810	120	26	,	,	PUNCT
ihlr-18810	120	27	as	as	ADV
ihlr-18810	120	28	well	well	ADV
ihlr-18810	120	29	as	as	ADP
ihlr-18810	120	30	the	the	DET
ihlr-18810	120	31	conclusions	conclusion	NOUN
ihlr-18810	120	32	drawn	draw	VERB
ihlr-18810	120	33	from	from	ADP
ihlr-18810	120	34	these	these	DET
ihlr-18810	120	35	studies	study	NOUN
ihlr-18810	120	36	regarding	regard	VERB
ihlr-18810	120	37	the	the	DET
ihlr-18810	120	38	safety	safety	NOUN
ihlr-18810	120	39	and	and	CCONJ
ihlr-18810	120	40	efficacy	efficacy	NOUN
ihlr-18810	120	41	of	of	ADP
ihlr-18810	120	42	the	the	DET
ihlr-18810	120	43	device	device	NOUN
ihlr-18810	120	44	.	.	PUNCT
ihlr-18810	121	1	39	39	NUM
ihlr-18810	122	1	the	the	DET
ihlr-18810	122	2	application	application	NOUN
ihlr-18810	122	3	also	also	ADV
ihlr-18810	122	4	requires	require	VERB
ihlr-18810	122	5	a	a	DET
ihlr-18810	122	6	clinical	clinical	ADJ
ihlr-18810	122	7	investigations	investigation	NOUN
ihlr-18810	122	8	section	section	NOUN
ihlr-18810	122	9	in	in	ADP
ihlr-18810	122	10	which	which	PRON
ihlr-18810	122	11	study	study	NOUN
ihlr-18810	122	12	protocols	protocol	NOUN
ihlr-18810	122	13	,	,	PUNCT
ihlr-18810	122	14	safety	safety	NOUN
ihlr-18810	122	15	and	and	CCONJ
ihlr-18810	122	16	effectiveness	effectiveness	NOUN
ihlr-18810	122	17	data	datum	NOUN
ihlr-18810	122	18	,	,	PUNCT
ihlr-18810	122	19	adverse	adverse	ADJ
ihlr-18810	122	20	reactions	reaction	NOUN
ihlr-18810	122	21	,	,	PUNCT
ihlr-18810	122	22	complications	complication	NOUN
ihlr-18810	122	23	,	,	PUNCT
ihlr-18810	122	24	device	device	NOUN
ihlr-18810	122	25	failures	failure	NOUN
ihlr-18810	122	26	,	,	PUNCT
ihlr-18810	122	27	patient	patient	ADJ
ihlr-18810	122	28	information	information	NOUN
ihlr-18810	122	29	and	and	CCONJ
ihlr-18810	122	30	complaints	complaint	NOUN
ihlr-18810	122	31	,	,	PUNCT
ihlr-18810	122	32	and	and	CCONJ
ihlr-18810	122	33	other	other	ADJ
ihlr-18810	122	34	clinical	clinical	ADJ
ihlr-18810	122	35	investigation	investigation	NOUN
ihlr-18810	122	36	information	information	NOUN
ihlr-18810	122	37	are	be	AUX
ihlr-18810	122	38	disclosed	disclose	VERB
ihlr-18810	122	39	.	.	PUNCT
ihlr-18810	123	1	40	40	NUM
ihlr-18810	124	1	it	it	PRON
ihlr-18810	124	2	is	be	AUX
ihlr-18810	124	3	essential	essential	ADJ
ihlr-18810	124	4	that	that	SCONJ
ihlr-18810	124	5	the	the	DET
ihlr-18810	124	6	demonstrations	demonstration	NOUN
ihlr-18810	124	7	of	of	ADP
ihlr-18810	124	8	safety	safety	NOUN
ihlr-18810	124	9	and	and	CCONJ
ihlr-18810	124	10	effectiveness	effectiveness	NOUN
ihlr-18810	124	11	of	of	ADP
ihlr-18810	124	12	the	the	DET
ihlr-18810	124	13	device	device	NOUN
ihlr-18810	124	14	are	be	AUX
ihlr-18810	124	15	founded	found	VERB
ihlr-18810	124	16	on	on	ADP
ihlr-18810	124	17	good	good	ADJ
ihlr-18810	124	18	science	science	NOUN
ihlr-18810	124	19	and	and	CCONJ
ihlr-18810	124	20	good	good	ADJ
ihlr-18810	124	21	scientific	scientific	ADJ
ihlr-18810	124	22	writing	writing	NOUN
ihlr-18810	124	23	;	;	PUNCT
ihlr-18810	124	24	if	if	SCONJ
ihlr-18810	124	25	such	such	ADJ
ihlr-18810	124	26	information	information	NOUN
ihlr-18810	124	27	is	be	AUX
ihlr-18810	124	28	lacking	lack	VERB
ihlr-18810	124	29	,	,	PUNCT
ihlr-18810	124	30	the	the	DET
ihlr-18810	124	31	fda	fda	PROPN
ihlr-18810	124	32	will	will	AUX
ihlr-18810	124	33	refuse	refuse	VERB
ihlr-18810	124	34	to	to	PART
ihlr-18810	124	35	file	file	VERB
ihlr-18810	124	36	the	the	DET
ihlr-18810	124	37	pma	pma	NOUN
ihlr-18810	124	38	application	application	NOUN
ihlr-18810	124	39	.	.	PUNCT
ihlr-18810	125	1	41	41	NUM
ihlr-18810	125	2	fda	fda	PROPN
ihlr-18810	125	3	regulations	regulation	NOUN
ihlr-18810	125	4	provide	provide	VERB
ihlr-18810	125	5	180	180	NUM
ihlr-18810	125	6	days	day	NOUN
ihlr-18810	125	7	to	to	PART
ihlr-18810	125	8	review	review	VERB
ihlr-18810	125	9	the	the	DET
ihlr-18810	125	10	pma	pma	NOUN
ihlr-18810	125	11	and	and	CCONJ
ihlr-18810	125	12	make	make	VERB
ihlr-18810	125	13	a	a	DET
ihlr-18810	125	14	determination	determination	NOUN
ihlr-18810	125	15	.	.	PUNCT
ihlr-18810	126	1	42	42	NUM
ihlr-18810	126	2	in	in	ADP
ihlr-18810	126	3	practice	practice	NOUN
ihlr-18810	126	4	,	,	PUNCT
ihlr-18810	126	5	however	however	ADV
ihlr-18810	126	6	,	,	PUNCT
ihlr-18810	126	7	86	86	NUM
ihlr-18810	126	8	medical	medical	ADJ
ihlr-18810	126	9	devices	device	NOUN
ihlr-18810	126	10	:	:	PUNCT
ihlr-18810	126	11	premarket	premarket	NOUN
ihlr-18810	126	12	approvals	approval	NOUN
ihlr-18810	126	13	,	,	PUNCT
ihlr-18810	126	14	u.s	u.s	PROPN
ihlr-18810	126	15	.	.	PROPN
ihlr-18810	126	16	food	food	NOUN
ihlr-18810	126	17	and	and	CCONJ
ihlr-18810	126	18	drug	drug	NOUN
ihlr-18810	126	19	admin	admin	PROPN
ihlr-18810	126	20	.	.	PROPN
ihlr-18810	126	21	,	,	PUNCT
ihlr-18810	126	22	http://www.fda.gov/medicaldevices/productsandmedical	http://www.fda.gov/medicaldevices/productsandmedical	PROPN
ihlr-18810	126	23	procedures	procedure	NOUN
ihlr-18810	126	24	/	/	SYM
ihlr-18810	126	25	deviceapprovalsandclearances	deviceapprovalsandclearance	NOUN
ihlr-18810	126	26	/	/	SYM
ihlr-18810	126	27	pmaapprovals	pmaapproval	NOUN
ihlr-18810	126	28	/	/	SYM
ihlr-18810	126	29	default.htm	default.htm	X
ihlr-18810	126	30	(	(	PUNCT
ihlr-18810	126	31	last	last	ADV
ihlr-18810	126	32	visited	visit	VERB
ihlr-18810	126	33	nov	nov	PROPN
ihlr-18810	126	34	.	.	PROPN
ihlr-18810	126	35	26	26	NUM
ihlr-18810	126	36	,	,	PUNCT
ihlr-18810	126	37	2012	2012	NUM
ihlr-18810	126	38	)	)	PUNCT
ihlr-18810	126	39	.	.	PUNCT
ihlr-18810	127	1	3	3	NUM
ihlr-18810	127	2	center	center	NOUN
ihlr-18810	127	3	for	for	ADP
ihlr-18810	127	4	devices	device	NOUN
ihlr-18810	127	5	and	and	CCONJ
ihlr-18810	127	6	radiological	radiological	ADJ
ihlr-18810	127	7	health	health	NOUN
ihlr-18810	127	8	,	,	PUNCT
ihlr-18810	127	9	alternate	alternate	ADJ
ihlr-18810	127	10	approaches	approach	NOUN
ihlr-18810	127	11	to	to	ADP
ihlr-18810	127	12	demonstrating	demonstrate	VERB
ihlr-18810	127	13	substantial	substantial	ADJ
ihlr-18810	127	14	equivalence	equivalence	NOUN
ihlr-18810	127	15	in	in	ADP
ihlr-18810	127	16	premarket	premarket	NOUN
ihlr-18810	127	17	notifications	notification	NOUN
ihlr-18810	127	18	:	:	PUNCT
ihlr-18810	127	19	final	final	ADJ
ihlr-18810	127	20	guidance	guidance	NOUN
ihlr-18810	127	21	3	3	NUM
ihlr-18810	127	22	(	(	PUNCT
ihlr-18810	127	23	1998	1998	NUM
ihlr-18810	127	24	)	)	PUNCT
ihlr-18810	127	25	,	,	PUNCT
ihlr-18810	127	26	available	available	ADJ
ihlr-18810	127	27	at	at	ADP
ihlr-18810	127	28	http://www.fda.gov/downloads/medicaldevices/deviceregulationand	http://www.fda.gov/downloads/medicaldevices/deviceregulationand	NOUN
ihlr-18810	127	29	guidance	guidance	NOUN
ihlr-18810	127	30	/	/	SYM
ihlr-18810	127	31	guidancedocuments	guidancedocument	NOUN
ihlr-18810	127	32	/	/	SYM
ihlr-18810	127	33	ucmo80189.pdf	ucmo80189.pdf	NOUN
ihlr-18810	127	34	.	.	PUNCT
ihlr-18810	128	1	38	38	NUM
ihlr-18810	129	1	i	i	PRON
ihlr-18810	129	2	d.	d.	PROPN
ihlr-18810	129	3	39	39	NUM
ihlr-18810	129	4	21	21	NUM
ihlr-18810	129	5	c.f.r	c.f.r	NOUN
ihlr-18810	129	6	.	.	PUNCT
ihlr-18810	130	1	§	§	PROPN
ihlr-18810	130	2	814.20(b)(3)(v)-(vi	814.20(b)(3)(v)-(vi	PROPN
ihlr-18810	130	3	)	)	PUNCT
ihlr-18810	130	4	(	(	PUNCT
ihlr-18810	130	5	2012	2012	NUM
ihlr-18810	130	6	)	)	PUNCT
ihlr-18810	130	7	.	.	PUNCT
ihlr-18810	131	1	40	40	NUM
ihlr-18810	131	2	21.c.f.r	21.c.f.r	NOUN
ihlr-18810	131	3	.	.	PUNCT
ihlr-18810	132	1	§	§	PROPN
ihlr-18810	132	2	814.20(b)(6	814.20(b)(6	NUM
ihlr-18810	132	3	)	)	PUNCT
ihlr-18810	132	4	(	(	PUNCT
ihlr-18810	132	5	2012	2012	NUM
ihlr-18810	132	6	)	)	PUNCT
ihlr-18810	132	7	.	.	PUNCT
ihlr-18810	133	1	41	41	NUM
ihlr-18810	133	2	medical	medical	ADJ
ihlr-18810	133	3	devices	device	NOUN
ihlr-18810	133	4	:	:	PUNCT
ihlr-18810	133	5	premarket	premarket	NOUN
ihlr-18810	133	6	approval	approval	NOUN
ihlr-18810	133	7	(	(	PUNCT
ihlr-18810	133	8	pa	pa	PROPN
ihlr-18810	133	9	)	)	PUNCT
ihlr-18810	133	10	,	,	PUNCT
ihlr-18810	133	11	u.s	u.s	PROPN
ihlr-18810	133	12	.	.	PROPN
ihlr-18810	133	13	food	food	NOUN
ihlr-18810	133	14	and	and	CCONJ
ihlr-18810	133	15	drug	drug	NOUN
ihlr-18810	133	16	admin	admin	PROPN
ihlr-18810	133	17	.	.	PUNCT
ihlr-18810	133	18	,	,	PUNCT
ihlr-18810	133	19	http://www.fda.gov/medicaldevices/deviceregulationand	http://www.fda.gov/medicaldevices/deviceregulationand	ADV
ihlr-18810	133	20	guidance	guidance	NOUN
ihlr-18810	133	21	/	/	SYM
ihlr-18810	133	22	howtomarketyourdevice	howtomarketyourdevice	NOUN
ihlr-18810	133	23	/	/	SYM
ihlr-18810	133	24	premarketsubmissions	premarketsubmission	NOUN
ihlr-18810	133	25	/	/	SYM
ihlr-18810	133	26	premarketapp	premarketapp	NOUN
ihlr-18810	133	27	rovalpmaldefault.htm	rovalpmaldefault.htm	X
ihlr-18810	133	28	(	(	PUNCT
ihlr-18810	133	29	last	last	ADJ
ihlr-18810	133	30	visited	visit	VERB
ihlr-18810	133	31	nov	nov	PROPN
ihlr-18810	133	32	.	.	PROPN
ihlr-18810	133	33	26	26	NUM
ihlr-18810	133	34	,	,	PUNCT
ihlr-18810	133	35	2012	2012	NUM
ihlr-18810	133	36	)	)	PUNCT
ihlr-18810	134	1	[	[	X
ihlr-18810	134	2	hereinafter	hereinafter	NOUN
ihlr-18810	134	3	pal41	pal41	PROPN
ihlr-18810	134	4	.	.	PUNCT
ihlr-18810	135	1	42	42	NUM
ihlr-18810	135	2	21	21	NUM
ihlr-18810	135	3	c.f.r	c.f.r	NOUN
ihlr-18810	135	4	.	.	PUNCT
ihlr-18810	136	1	§	§	PROPN
ihlr-18810	136	2	814.40	814.40	NUM
ihlr-18810	136	3	(	(	PUNCT
ihlr-18810	136	4	2012	2012	NUM
ihlr-18810	136	5	)	)	PUNCT
ihlr-18810	136	6	.	.	PUNCT
ihlr-18810	137	1	vol	vol	NOUN
ihlr-18810	137	2	.	.	PUNCT
ihlr-18810	138	1	10:1124	10:1124	PROPN
ihlr-18810	139	1	510(k	510(k	X
ihlr-18810	139	2	)	)	PUNCT
ihlr-18810	139	3	clearance	clearance	NOUN
ihlr-18810	139	4	the	the	DET
ihlr-18810	139	5	review	review	NOUN
ihlr-18810	139	6	time	time	NOUN
ihlr-18810	139	7	is	be	AUX
ihlr-18810	139	8	normally	normally	ADV
ihlr-18810	139	9	longer.43	longer.43	VERB
ihlr-18810	139	10	it	it	PRON
ihlr-18810	139	11	has	have	AUX
ihlr-18810	139	12	been	be	AUX
ihlr-18810	139	13	reported	report	VERB
ihlr-18810	139	14	that	that	SCONJ
ihlr-18810	139	15	the	the	DET
ihlr-18810	139	16	fda	fda	PROPN
ihlr-18810	139	17	spends	spend	VERB
ihlr-18810	139	18	"	"	PUNCT
ihlr-18810	139	19	an	an	DET
ihlr-18810	139	20	average	average	NOUN
ihlr-18810	139	21	of	of	ADP
ihlr-18810	139	22	1,200	1,200	NUM
ihlr-18810	139	23	hours	hour	NOUN
ihlr-18810	139	24	on	on	ADP
ihlr-18810	139	25	each	each	DET
ihlr-18810	139	26	submission	submission	NOUN
ihlr-18810	139	27	.	.	PUNCT
ihlr-18810	140	1	"44	"44	PUNCT
ihlr-18810	140	2	although	although	SCONJ
ihlr-18810	140	3	this	this	DET
ihlr-18810	140	4	review	review	NOUN
ihlr-18810	140	5	is	be	AUX
ihlr-18810	140	6	detailed	detail	VERB
ihlr-18810	140	7	,	,	PUNCT
ihlr-18810	140	8	there	there	PRON
ihlr-18810	140	9	is	be	VERB
ihlr-18810	140	10	some	some	DET
ihlr-18810	140	11	debate	debate	NOUN
ihlr-18810	140	12	as	as	ADP
ihlr-18810	140	13	to	to	ADP
ihlr-18810	140	14	the	the	DET
ihlr-18810	140	15	effectiveness	effectiveness	NOUN
ihlr-18810	140	16	of	of	ADP
ihlr-18810	140	17	this	this	DET
ihlr-18810	140	18	review	review	NOUN
ihlr-18810	140	19	process	process	NOUN
ihlr-18810	140	20	.	.	PUNCT
ihlr-18810	141	1	45	45	NUM
ihlr-18810	141	2	.	.	PUNCT
ihlr-18810	142	1	to	to	PART
ihlr-18810	142	2	avoid	avoid	VERB
ihlr-18810	142	3	this	this	DET
ihlr-18810	142	4	lengthy	lengthy	ADJ
ihlr-18810	142	5	pma	pma	NOUN
ihlr-18810	142	6	process	process	NOUN
ihlr-18810	142	7	,	,	PUNCT
ihlr-18810	142	8	manufacturers	manufacturer	NOUN
ihlr-18810	142	9	can	can	AUX
ihlr-18810	142	10	generally	generally	ADV
ihlr-18810	142	11	attempt	attempt	VERB
ihlr-18810	142	12	to	to	PART
ihlr-18810	142	13	bring	bring	VERB
ihlr-18810	142	14	their	their	PRON
ihlr-18810	142	15	device	device	NOUN
ihlr-18810	142	16	to	to	PART
ihlr-18810	142	17	market	market	VERB
ihlr-18810	142	18	through	through	ADP
ihlr-18810	142	19	one	one	NUM
ihlr-18810	142	20	of	of	ADP
ihlr-18810	142	21	three	three	NUM
ihlr-18810	142	22	exemptions	exemption	NOUN
ihlr-18810	142	23	.	.	PUNCT
ihlr-18810	143	1	the	the	DET
ihlr-18810	143	2	first	first	ADJ
ihlr-18810	143	3	,	,	PUNCT
ihlr-18810	143	4	the	the	DET
ihlr-18810	143	5	investigational	investigational	ADJ
ihlr-18810	143	6	device	device	NOUN
ihlr-18810	143	7	exemption	exemption	NOUN
ihlr-18810	143	8	(	(	PUNCT
ihlr-18810	143	9	ide),46	ide),46	PROPN
ihlr-18810	143	10	is	be	AUX
ihlr-18810	143	11	available	available	ADJ
ihlr-18810	143	12	to	to	ADP
ihlr-18810	143	13	manufacturers	manufacturer	NOUN
ihlr-18810	143	14	who	who	PRON
ihlr-18810	143	15	want	want	VERB
ihlr-18810	143	16	to	to	PART
ihlr-18810	143	17	test	test	VERB
ihlr-18810	143	18	an	an	DET
ihlr-18810	143	19	experimental	experimental	ADJ
ihlr-18810	143	20	device	device	NOUN
ihlr-18810	143	21	on	on	ADP
ihlr-18810	143	22	humans	human	NOUN
ihlr-18810	143	23	,	,	PUNCT
ihlr-18810	143	24	or	or	CCONJ
ihlr-18810	143	25	who	who	PRON
ihlr-18810	143	26	want	want	VERB
ihlr-18810	143	27	to	to	PART
ihlr-18810	143	28	test	test	VERB
ihlr-18810	143	29	an	an	DET
ihlr-18810	143	30	already	already	ADV
ihlr-18810	143	31	available	available	ADJ
ihlr-18810	143	32	device	device	NOUN
ihlr-18810	143	33	for	for	ADP
ihlr-18810	143	34	use	use	NOUN
ihlr-18810	143	35	for	for	ADP
ihlr-18810	143	36	a	a	DET
ihlr-18810	143	37	new	new	ADJ
ihlr-18810	143	38	indication.47	indication.47	NOUN
ihlr-18810	143	39	the	the	DET
ihlr-18810	143	40	manufacturer	manufacturer	NOUN
ihlr-18810	143	41	must	must	AUX
ihlr-18810	143	42	obtain	obtain	VERB
ihlr-18810	143	43	permission	permission	NOUN
ihlr-18810	143	44	for	for	ADP
ihlr-18810	143	45	these	these	DET
ihlr-18810	143	46	tests	test	NOUN
ihlr-18810	143	47	from	from	ADP
ihlr-18810	143	48	both	both	CCONJ
ihlr-18810	143	49	the	the	DET
ihlr-18810	143	50	fda	fda	PROPN
ihlr-18810	143	51	and	and	CCONJ
ihlr-18810	143	52	from	from	ADP
ihlr-18810	143	53	the	the	DET
ihlr-18810	143	54	institutional	institutional	ADJ
ihlr-18810	143	55	review	review	PROPN
ihlr-18810	143	56	board	board	NOUN
ihlr-18810	143	57	(	(	PUNCT
ihlr-18810	143	58	irb	irb	PROPN
ihlr-18810	143	59	)	)	PUNCT
ihlr-18810	143	60	of	of	ADP
ihlr-18810	143	61	the	the	DET
ihlr-18810	143	62	institution	institution	NOUN
ihlr-18810	143	63	at	at	ADP
ihlr-18810	143	64	which	which	PRON
ihlr-18810	143	65	the	the	DET
ihlr-18810	143	66	testing	testing	NOUN
ihlr-18810	143	67	will	will	AUX
ihlr-18810	143	68	be	be	AUX
ihlr-18810	143	69	performed	perform	VERB
ihlr-18810	143	70	.	.	PUNCT
ihlr-18810	144	1	48	48	NUM
ihlr-18810	144	2	to	to	PART
ihlr-18810	144	3	obtain	obtain	VERB
ihlr-18810	144	4	an	an	DET
ihlr-18810	144	5	ide	ide	NOUN
ihlr-18810	144	6	,	,	PUNCT
ihlr-18810	144	7	the	the	DET
ihlr-18810	144	8	applicant	applicant	NOUN
ihlr-18810	144	9	must	must	AUX
ihlr-18810	144	10	submit	submit	VERB
ihlr-18810	144	11	to	to	ADP
ihlr-18810	144	12	the	the	DET
ihlr-18810	144	13	fda	fda	PROPN
ihlr-18810	144	14	information	information	NOUN
ihlr-18810	144	15	about	about	ADP
ihlr-18810	144	16	the	the	DET
ihlr-18810	144	17	device	device	NOUN
ihlr-18810	144	18	and	and	CCONJ
ihlr-18810	144	19	how	how	SCONJ
ihlr-18810	144	20	the	the	DET
ihlr-18810	144	21	experiment	experiment	NOUN
ihlr-18810	144	22	will	will	AUX
ihlr-18810	144	23	be	be	AUX
ihlr-18810	144	24	conducted	conduct	VERB
ihlr-18810	144	25	.	.	PUNCT
ihlr-18810	145	1	49	49	NUM
ihlr-18810	146	1	it	it	PRON
ihlr-18810	146	2	is	be	AUX
ihlr-18810	146	3	primarily	primarily	ADV
ihlr-18810	146	4	upon	upon	SCONJ
ihlr-18810	146	5	this	this	DET
ihlr-18810	146	6	submission	submission	NOUN
ihlr-18810	146	7	that	that	SCONJ
ihlr-18810	146	8	the	the	DET
ihlr-18810	146	9	fda	fda	PROPN
ihlr-18810	146	10	makes	make	VERB
ihlr-18810	146	11	its	its	PRON
ihlr-18810	146	12	decision	decision	NOUN
ihlr-18810	146	13	,	,	PUNCT
ihlr-18810	146	14	and	and	CCONJ
ihlr-18810	146	15	approval	approval	NOUN
ihlr-18810	146	16	does	do	AUX
ihlr-18810	146	17	not	not	PART
ihlr-18810	146	18	involve	involve	VERB
ihlr-18810	146	19	a	a	DET
ihlr-18810	146	20	finding	finding	NOUN
ihlr-18810	146	21	by	by	ADP
ihlr-18810	146	22	the	the	DET
ihlr-18810	146	23	agency	agency	NOUN
ihlr-18810	146	24	that	that	SCONJ
ihlr-18810	146	25	the	the	DET
ihlr-18810	146	26	manufacturer	manufacturer	NOUN
ihlr-18810	146	27	has	have	AUX
ihlr-18810	146	28	made	make	VERB
ihlr-18810	146	29	correct	correct	ADJ
ihlr-18810	146	30	decisions	decision	NOUN
ihlr-18810	146	31	about	about	ADP
ihlr-18810	146	32	the	the	DET
ihlr-18810	146	33	design	design	NOUN
ihlr-18810	146	34	,	,	PUNCT
ihlr-18810	146	35	labeling	labeling	NOUN
ihlr-18810	146	36	,	,	PUNCT
ihlr-18810	146	37	or	or	CCONJ
ihlr-18810	146	38	production	production	NOUN
ihlr-18810	146	39	of	of	ADP
ihlr-18810	146	40	the	the	DET
ihlr-18810	146	41	device	device	NOUN
ihlr-18810	146	42	under	under	ADP
ihlr-18810	146	43	investigation.5	investigation.5	PROPN
ihlr-18810	146	44	0	0	NUM
ihlr-18810	146	45	43	43	NUM
ihlr-18810	146	46	pam	pam	NOUN
ihlr-18810	146	47	,	,	PUNCT
ihlr-18810	146	48	supra	supra	PROPN
ihlr-18810	146	49	note	note	NOUN
ihlr-18810	146	50	41	41	NUM
ihlr-18810	146	51	.	.	PUNCT
ihlr-18810	146	52	44	44	NUM
ihlr-18810	146	53	medtronic	medtronic	PROPN
ihlr-18810	146	54	,	,	PUNCT
ihlr-18810	146	55	inc	inc	PROPN
ihlr-18810	146	56	.	.	PROPN
ihlr-18810	147	1	v.	v.	PROPN
ihlr-18810	147	2	lohr	lohr	PROPN
ihlr-18810	147	3	,	,	PUNCT
ihlr-18810	147	4	518	518	NUM
ihlr-18810	147	5	u.s	u.s	PROPN
ihlr-18810	147	6	.	.	PROPN
ihlr-18810	147	7	470	470	NUM
ihlr-18810	147	8	,	,	PUNCT
ihlr-18810	147	9	477	477	NUM
ihlr-18810	147	10	(	(	PUNCT
ihlr-18810	147	11	1996	1996	NUM
ihlr-18810	147	12	)	)	PUNCT
ihlr-18810	147	13	.	.	PUNCT
ihlr-18810	148	1	45	45	NUM
ihlr-18810	148	2	see	see	VERB
ihlr-18810	148	3	,	,	PUNCT
ihlr-18810	148	4	e.g.	e.g.	ADV
ihlr-18810	148	5	,	,	PUNCT
ihlr-18810	148	6	david	david	PROPN
ihlr-18810	148	7	brennan	brennan	PROPN
ihlr-18810	148	8	,	,	PUNCT
ihlr-18810	148	9	federal	federal	ADJ
ihlr-18810	148	10	preemption	preemption	NOUN
ihlr-18810	148	11	of	of	ADP
ihlr-18810	148	12	all	all	DET
ihlr-18810	148	13	state	state	NOUN
ihlr-18810	148	14	law	law	NOUN
ihlr-18810	148	15	tort	tort	NOUN
ihlr-18810	148	16	claims	claim	NOUN
ihlr-18810	148	17	in	in	ADP
ihlr-18810	148	18	riegel	riegel	PROPN
ihlr-18810	148	19	v.	v.	PROPN
ihlr-18810	148	20	medtronic	medtronic	PROPN
ihlr-18810	148	21	:	:	PUNCT
ihlr-18810	148	22	a	a	DET
ihlr-18810	148	23	need	need	NOUN
ihlr-18810	148	24	to	to	PART
ihlr-18810	148	25	undo	undo	VERB
ihlr-18810	148	26	a	a	DET
ihlr-18810	148	27	serious	serious	ADJ
ihlr-18810	148	28	wrong	wrong	NOUN
ihlr-18810	148	29	,	,	PUNCT
ihlr-18810	148	30	36	36	NUM
ihlr-18810	148	31	w.	w.	PROPN
ihlr-18810	148	32	st	st	PROPN
ihlr-18810	148	33	.	.	PROPN
ihlr-18810	148	34	u.	u.	PROPN
ihlr-18810	148	35	l.	l.	PROPN
ihlr-18810	148	36	rev	rev	PROPN
ihlr-18810	148	37	.	.	PROPN
ihlr-18810	148	38	137	137	NUM
ihlr-18810	148	39	,	,	PUNCT
ihlr-18810	148	40	161	161	NUM
ihlr-18810	148	41	-	-	SYM
ihlr-18810	148	42	64	64	NUM
ihlr-18810	148	43	(	(	PUNCT
ihlr-18810	148	44	2009	2009	NUM
ihlr-18810	148	45	)	)	PUNCT
ihlr-18810	148	46	(	(	PUNCT
ihlr-18810	148	47	"	"	PUNCT
ihlr-18810	148	48	pogo	pogo	NOUN
ihlr-18810	148	49	[	[	X
ihlr-18810	148	50	project	project	NOUN
ihlr-18810	148	51	on	on	ADP
ihlr-18810	148	52	government	government	NOUN
ihlr-18810	148	53	oversight	oversight	NOUN
ihlr-18810	148	54	]	]	PUNCT
ihlr-18810	148	55	observed	observe	VERB
ihlr-18810	148	56	that	that	SCONJ
ihlr-18810	148	57	the	the	DET
ihlr-18810	148	58	effect	effect	NOUN
ihlr-18810	148	59	of	of	ADP
ihlr-18810	148	60	the	the	DET
ihlr-18810	148	61	riegel	riegel	NOUN
ihlr-18810	148	62	decision	decision	NOUN
ihlr-18810	148	63	by	by	ADP
ihlr-18810	148	64	the	the	DET
ihlr-18810	148	65	u.s	u.s	PROPN
ihlr-18810	148	66	.	.	PROPN
ihlr-18810	148	67	supreme	supreme	PROPN
ihlr-18810	148	68	court	court	PROPN
ihlr-18810	148	69	was	be	AUX
ihlr-18810	148	70	to	to	PART
ihlr-18810	148	71	nearly	nearly	ADV
ihlr-18810	148	72	'	'	PUNCT
ihlr-18810	148	73	condone	condone	VERB
ihlr-18810	148	74	the	the	DET
ihlr-18810	148	75	notion	notion	NOUN
ihlr-18810	148	76	'	'	PUNCT
ihlr-18810	148	77	challenged	challenge	VERB
ihlr-18810	148	78	repeatedly	repeatedly	ADV
ihlr-18810	148	79	.	.	PUNCT
ihlr-18810	148	80	.	.	PUNCT
ihlr-18810	148	81	.	.	PUNCT
ihlr-18810	149	1	that	that	SCONJ
ihlr-18810	149	2	the	the	DET
ihlr-18810	149	3	'	'	PUNCT
ihlr-18810	149	4	fda	fda	PROPN
ihlr-18810	149	5	'	'	PUNCT
ihlr-18810	149	6	spends	spend	VERB
ihlr-18810	149	7	an	an	DET
ihlr-18810	149	8	average	average	NOUN
ihlr-18810	149	9	of	of	ADP
ihlr-18810	149	10	1,200	1,200	NUM
ihlr-18810	149	11	hours	hour	NOUN
ihlr-18810	149	12	reviewing	review	VERB
ihlr-18810	149	13	each	each	DET
ihlr-18810	149	14	application	application	NOUN
ihlr-18810	149	15	...	...	PUNCT
ihlr-18810	150	1	and	and	CCONJ
ihlr-18810	150	2	[	[	X
ihlr-18810	150	3	it	it	PRON
ihlr-18810	150	4	only	only	ADV
ihlr-18810	150	5	]	]	PUNCT
ihlr-18810	150	6	grants	grant	VERB
ihlr-18810	150	7	premarket	premarket	NOUN
ihlr-18810	150	8	approval	approval	NOUN
ihlr-18810	150	9	only	only	ADV
ihlr-18810	150	10	[	[	X
ihlr-18810	150	11	where	where	SCONJ
ihlr-18810	150	12	]	]	PUNCT
ihlr-18810	150	13	it	it	PRON
ihlr-18810	150	14	finds	find	VERB
ihlr-18810	150	15	[	[	PUNCT
ihlr-18810	150	16	that	that	SCONJ
ihlr-18810	150	17	]	]	PUNCT
ihlr-18810	150	18	there	there	PRON
ihlr-18810	150	19	is	be	VERB
ihlr-18810	150	20	a	a	DET
ihlr-18810	150	21	'	'	PUNCT
ihlr-18810	150	22	reasonable	reasonable	ADJ
ihlr-18810	150	23	assurance	assurance	NOUN
ihlr-18810	150	24	'	'	PUNCT
ihlr-18810	150	25	of	of	ADP
ihlr-18810	150	26	the	the	DET
ihlr-18810	150	27	device	device	NOUN
ihlr-18810	150	28	's	's	PART
ihlr-18810	150	29	'	'	NOUN
ihlr-18810	150	30	safety	safety	NOUN
ihlr-18810	150	31	and	and	CCONJ
ihlr-18810	150	32	effectiveness	effectiveness	NOUN
ihlr-18810	150	33	.	.	PUNCT
ihlr-18810	150	34	"	"	PUNCT
ihlr-18810	151	1	independent	independent	ADJ
ihlr-18810	151	2	of	of	ADP
ihlr-18810	151	3	pogo	pogo	NOUN
ihlr-18810	151	4	and	and	CCONJ
ihlr-18810	151	5	the	the	DET
ihlr-18810	151	6	fda	fda	PROPN
ihlr-18810	151	7	's	's	PART
ihlr-18810	151	8	suggestions	suggestion	NOUN
ihlr-18810	151	9	of	of	ADP
ihlr-18810	151	10	a	a	DET
ihlr-18810	151	11	rigorous	rigorous	ADJ
ihlr-18810	151	12	and	and	CCONJ
ihlr-18810	151	13	robust	robust	ADJ
ihlr-18810	151	14	application	application	NOUN
ihlr-18810	151	15	of	of	ADP
ihlr-18810	151	16	the	the	DET
ihlr-18810	151	17	mda	mda	PROPN
ihlr-18810	151	18	to	to	ADP
ihlr-18810	151	19	its	its	PRON
ihlr-18810	151	20	processes	process	NOUN
ihlr-18810	151	21	to	to	PART
ihlr-18810	151	22	prevent	prevent	VERB
ihlr-18810	151	23	inadequately	inadequately	ADV
ihlr-18810	151	24	reviewed	review	VERB
ihlr-18810	151	25	medical	medical	ADJ
ihlr-18810	151	26	devices	device	NOUN
ihlr-18810	151	27	from	from	ADP
ihlr-18810	151	28	entering	enter	VERB
ihlr-18810	151	29	the	the	DET
ihlr-18810	151	30	market	market	NOUN
ihlr-18810	151	31	place	place	NOUN
ihlr-18810	151	32	,	,	PUNCT
ihlr-18810	151	33	there	there	PRON
ihlr-18810	151	34	is	be	VERB
ihlr-18810	151	35	credible	credible	ADJ
ihlr-18810	151	36	and	and	CCONJ
ihlr-18810	151	37	sufficient	sufficient	ADJ
ihlr-18810	151	38	information	information	NOUN
ihlr-18810	151	39	.	.	PUNCT
ihlr-18810	151	40	.	.	PUNCT
ihlr-18810	152	1	.	.	PUNCT
ihlr-18810	153	1	coming	come	VERB
ihlr-18810	153	2	from	from	ADP
ihlr-18810	153	3	the	the	DET
ihlr-18810	153	4	fda	fda	PROPN
ihlr-18810	153	5	's	's	PART
ihlr-18810	153	6	own	own	ADJ
ihlr-18810	153	7	scientists	scientist	NOUN
ihlr-18810	153	8	,	,	PUNCT
ihlr-18810	153	9	congressional	congressional	ADJ
ihlr-18810	153	10	lead	lead	NOUN
ihlr-18810	153	11	-	-	PUNCT
ihlr-18810	153	12	ers	er	NOUN
ihlr-18810	153	13	,	,	PUNCT
ihlr-18810	153	14	nongovernmental	nongovernmental	ADJ
ihlr-18810	153	15	organizations	organization	NOUN
ihlr-18810	153	16	.	.	PUNCT
ihlr-18810	154	1	..	..	PUNCT
ihlr-18810	155	1	and	and	CCONJ
ihlr-18810	155	2	the	the	DET
ihlr-18810	155	3	general	general	ADJ
ihlr-18810	155	4	accountability	accountability	NOUN
ihlr-18810	155	5	office	office	NOUN
ihlr-18810	155	6	.	.	PUNCT
ihlr-18810	155	7	.	.	PUNCT
ihlr-18810	155	8	.	.	PUNCT
ihlr-18810	156	1	to	to	PART
ihlr-18810	156	2	demonstrate	demonstrate	VERB
ihlr-18810	156	3	substantial	substantial	ADJ
ihlr-18810	156	4	doubt	doubt	NOUN
ihlr-18810	156	5	as	as	ADP
ihlr-18810	156	6	to	to	ADP
ihlr-18810	156	7	the	the	DET
ihlr-18810	156	8	overall	overall	ADJ
ihlr-18810	156	9	effectiveness	effectiveness	NOUN
ihlr-18810	156	10	of	of	ADP
ihlr-18810	156	11	the	the	DET
ihlr-18810	156	12	agency	agency	NOUN
ihlr-18810	156	13	in	in	ADP
ihlr-18810	156	14	the	the	DET
ihlr-18810	156	15	sphere	sphere	NOUN
ihlr-18810	156	16	of	of	ADP
ihlr-18810	156	17	class	class	NOUN
ihlr-18810	156	18	iii	iii	PROPN
ihlr-18810	156	19	medical	medical	ADJ
ihlr-18810	156	20	devices	device	NOUN
ihlr-18810	156	21	.	.	PUNCT
ihlr-18810	157	1	"	"	PUNCT
ihlr-18810	157	2	)	)	PUNCT
ihlr-18810	157	3	.	.	PUNCT
ihlr-18810	158	1	46	46	NUM
ihlr-18810	158	2	21	21	NUM
ihlr-18810	158	3	u.s.c	u.s.c	NOUN
ihlr-18810	158	4	.	.	PUNCT
ihlr-18810	159	1	§	§	PROPN
ihlr-18810	159	2	360j(g	360j(g	NUM
ihlr-18810	159	3	)	)	PUNCT
ihlr-18810	159	4	(	(	PUNCT
ihlr-18810	159	5	2012	2012	NUM
ihlr-18810	159	6	)	)	PUNCT
ihlr-18810	159	7	.	.	PUNCT
ihlr-18810	160	1	47	47	NUM
ihlr-18810	160	2	leflar	leflar	ADJ
ihlr-18810	160	3	&	&	CCONJ
ihlr-18810	160	4	adler	adler	PROPN
ihlr-18810	160	5	,	,	PUNCT
ihlr-18810	160	6	supra	supra	PROPN
ihlr-18810	160	7	note	note	PROPN
ihlr-18810	160	8	16	16	NUM
ihlr-18810	160	9	,	,	PUNCT
ihlr-18810	160	10	at	at	ADP
ihlr-18810	160	11	721	721	NUM
ihlr-18810	160	12	-	-	SYM
ihlr-18810	160	13	22	22	NUM
ihlr-18810	160	14	.	.	PUNCT
ihlr-18810	161	1	48	48	NUM
ihlr-18810	162	1	i	i	PRON
ihlr-18810	162	2	d.	d.	PROPN
ihlr-18810	162	3	at	at	ADP
ihlr-18810	162	4	722	722	NUM
ihlr-18810	162	5	.	.	PUNCT
ihlr-18810	162	6	49	49	NUM
ihlr-18810	163	1	i	i	PRON
ihlr-18810	163	2	d.	d.	VERB
ihlr-18810	163	3	50	50	NUM
ihlr-18810	164	1	i	i	PRON
ihlr-18810	164	2	d.	d.	VERB
ihlr-18810	164	3	at	at	ADP
ihlr-18810	164	4	722	722	NUM
ihlr-18810	164	5	-	-	SYM
ihlr-18810	164	6	23	23	NUM
ihlr-18810	164	7	.	.	PUNCT
ihlr-18810	165	1	2013	2013	NUM
ihlr-18810	165	2	125	125	NUM
ihlr-18810	165	3	indiana	indiana	PROPN
ihlr-18810	165	4	health	health	PROPN
ihlr-18810	165	5	law	law	PROPN
ihlr-18810	165	6	review	review	VERB
ihlr-18810	165	7	ide	ide	NOUN
ihlr-18810	165	8	devices	device	NOUN
ihlr-18810	165	9	are	be	AUX
ihlr-18810	165	10	used	use	VERB
ihlr-18810	165	11	under	under	ADP
ihlr-18810	165	12	the	the	DET
ihlr-18810	165	13	supervision	supervision	NOUN
ihlr-18810	165	14	of	of	ADP
ihlr-18810	165	15	the	the	DET
ihlr-18810	165	16	fda	fda	PROPN
ihlr-18810	165	17	during	during	ADP
ihlr-18810	165	18	the	the	DET
ihlr-18810	165	19	trial	trial	NOUN
ihlr-18810	165	20	process	process	NOUN
ihlr-18810	165	21	and	and	CCONJ
ihlr-18810	165	22	after	after	ADP
ihlr-18810	165	23	,	,	PUNCT
ihlr-18810	165	24	and	and	CCONJ
ihlr-18810	165	25	the	the	DET
ihlr-18810	165	26	fda	fda	PROPN
ihlr-18810	165	27	is	be	AUX
ihlr-18810	165	28	able	able	ADJ
ihlr-18810	165	29	to	to	PART
ihlr-18810	165	30	then	then	ADV
ihlr-18810	165	31	impose	impose	VERB
ihlr-18810	165	32	requirements	requirement	NOUN
ihlr-18810	165	33	on	on	ADP
ihlr-18810	165	34	the	the	DET
ihlr-18810	165	35	device	device	NOUN
ihlr-18810	165	36	regarding	regard	VERB
ihlr-18810	165	37	design	design	NOUN
ihlr-18810	165	38	,	,	PUNCT
ihlr-18810	165	39	manufacture	manufacture	NOUN
ihlr-18810	165	40	,	,	PUNCT
ihlr-18810	165	41	and	and	CCONJ
ihlr-18810	165	42	safety.51	safety.51	NOUN
ihlr-18810	165	43	the	the	DET
ihlr-18810	165	44	requirements	requirement	NOUN
ihlr-18810	165	45	of	of	ADP
ihlr-18810	165	46	the	the	DET
ihlr-18810	165	47	pma	pma	NOUN
ihlr-18810	165	48	will	will	AUX
ihlr-18810	165	49	be	be	AUX
ihlr-18810	165	50	satisfied	satisfied	ADJ
ihlr-18810	165	51	and	and	CCONJ
ihlr-18810	165	52	the	the	DET
ihlr-18810	165	53	device	device	NOUN
ihlr-18810	165	54	will	will	AUX
ihlr-18810	165	55	receive	receive	VERB
ihlr-18810	165	56	pma	pma	NOUN
ihlr-18810	165	57	for	for	ADP
ihlr-18810	165	58	broader	broad	ADJ
ihlr-18810	165	59	use	use	NOUN
ihlr-18810	165	60	if	if	SCONJ
ihlr-18810	165	61	the	the	DET
ihlr-18810	165	62	ide	ide	NOUN
ihlr-18810	165	63	trials	trial	NOUN
ihlr-18810	165	64	are	be	AUX
ihlr-18810	165	65	able	able	ADJ
ihlr-18810	165	66	to	to	PART
ihlr-18810	165	67	prove	prove	VERB
ihlr-18810	165	68	the	the	DET
ihlr-18810	165	69	device	device	NOUN
ihlr-18810	165	70	is	be	AUX
ihlr-18810	165	71	satisfactorily	satisfactorily	ADV
ihlr-18810	165	72	safe	safe	ADJ
ihlr-18810	165	73	and	and	CCONJ
ihlr-18810	165	74	effective	effective	ADJ
ihlr-18810	165	75	.	.	PUNCT
ihlr-18810	166	1	52	52	NUM
ihlr-18810	166	2	a	a	DET
ihlr-18810	166	3	humanitarian	humanitarian	ADJ
ihlr-18810	166	4	device	device	NOUN
ihlr-18810	166	5	exemption	exemption	NOUN
ihlr-18810	166	6	(	(	PUNCT
ihlr-18810	166	7	hde	hde	PROPN
ihlr-18810	166	8	)	)	PUNCT
ihlr-18810	166	9	is	be	AUX
ihlr-18810	166	10	also	also	ADV
ihlr-18810	166	11	available	available	ADJ
ihlr-18810	166	12	to	to	PART
ihlr-18810	166	13	exempt	exempt	VERB
ihlr-18810	166	14	from	from	ADP
ihlr-18810	166	15	the	the	DET
ihlr-18810	166	16	premarket	premarket	NOUN
ihlr-18810	166	17	approval	approval	NOUN
ihlr-18810	166	18	process	process	NOUN
ihlr-18810	166	19	devices	device	NOUN
ihlr-18810	166	20	that	that	PRON
ihlr-18810	166	21	are	be	AUX
ihlr-18810	166	22	intended	intend	VERB
ihlr-18810	166	23	to	to	PART
ihlr-18810	166	24	benefit	benefit	VERB
ihlr-18810	166	25	only	only	ADV
ihlr-18810	166	26	very	very	ADV
ihlr-18810	166	27	small	small	ADJ
ihlr-18810	166	28	patient	patient	ADJ
ihlr-18810	166	29	populations	population	NOUN
ihlr-18810	166	30	through	through	ADP
ihlr-18810	166	31	treatment	treatment	NOUN
ihlr-18810	166	32	in	in	ADP
ihlr-18810	166	33	near	near	ADP
ihlr-18810	166	34	-	-	PUNCT
ihlr-18810	166	35	death	death	NOUN
ihlr-18810	166	36	situations	situation	NOUN
ihlr-18810	166	37	.	.	PUNCT
ihlr-18810	167	1	53	53	NUM
ihlr-18810	167	2	this	this	DET
ihlr-18810	167	3	exemption	exemption	NOUN
ihlr-18810	167	4	can	can	AUX
ihlr-18810	167	5	be	be	AUX
ihlr-18810	167	6	used	use	VERB
ihlr-18810	167	7	in	in	ADP
ihlr-18810	167	8	situations	situation	NOUN
ihlr-18810	167	9	where	where	SCONJ
ihlr-18810	167	10	the	the	DET
ihlr-18810	167	11	required	require	VERB
ihlr-18810	167	12	approval	approval	NOUN
ihlr-18810	167	13	by	by	ADP
ihlr-18810	167	14	an	an	DET
ihlr-18810	167	15	irb	irb	NOUN
ihlr-18810	167	16	can	can	AUX
ihlr-18810	167	17	not	not	PART
ihlr-18810	167	18	be	be	AUX
ihlr-18810	167	19	obtained	obtain	VERB
ihlr-18810	167	20	in	in	ADP
ihlr-18810	167	21	time	time	NOUN
ihlr-18810	167	22	to	to	PART
ihlr-18810	167	23	prevent	prevent	VERB
ihlr-18810	167	24	serious	serious	ADJ
ihlr-18810	167	25	harm	harm	NOUN
ihlr-18810	167	26	or	or	CCONJ
ihlr-18810	167	27	death	death	NOUN
ihlr-18810	167	28	to	to	ADP
ihlr-18810	167	29	a	a	DET
ihlr-18810	167	30	patient	patient	NOUN
ihlr-18810	167	31	.	.	PUNCT
ihlr-18810	168	1	54	54	NUM
ihlr-18810	168	2	the	the	DET
ihlr-18810	168	3	fda	fda	PROPN
ihlr-18810	168	4	guidelines	guideline	NOUN
ihlr-18810	168	5	permit	permit	VERB
ihlr-18810	168	6	the	the	DET
ihlr-18810	168	7	use	use	NOUN
ihlr-18810	168	8	of	of	ADP
ihlr-18810	168	9	the	the	DET
ihlr-18810	168	10	device	device	NOUN
ihlr-18810	168	11	in	in	ADP
ihlr-18810	168	12	these	these	DET
ihlr-18810	168	13	circumstances	circumstance	NOUN
ihlr-18810	168	14	for	for	ADP
ihlr-18810	168	15	purely	purely	ADV
ihlr-18810	168	16	humanitarian	humanitarian	ADJ
ihlr-18810	168	17	purposes	purpose	NOUN
ihlr-18810	168	18	,	,	PUNCT
ihlr-18810	168	19	and	and	CCONJ
ihlr-18810	168	20	this	this	DET
ihlr-18810	168	21	permission	permission	NOUN
ihlr-18810	168	22	is	be	AUX
ihlr-18810	168	23	not	not	PART
ihlr-18810	168	24	intended	intend	VERB
ihlr-18810	168	25	to	to	PART
ihlr-18810	168	26	equate	equate	VERB
ihlr-18810	168	27	with	with	ADP
ihlr-18810	168	28	a	a	DET
ihlr-18810	168	29	pma	pma	NOUN
ihlr-18810	168	30	approval	approval	NOUN
ihlr-18810	168	31	of	of	ADP
ihlr-18810	168	32	the	the	DET
ihlr-18810	168	33	safety	safety	NOUN
ihlr-18810	168	34	or	or	CCONJ
ihlr-18810	168	35	efficacy	efficacy	NOUN
ihlr-18810	168	36	of	of	ADP
ihlr-18810	168	37	the	the	DET
ihlr-18810	168	38	device.55	device.55	NOUN
ihlr-18810	168	39	neither	neither	CCONJ
ihlr-18810	168	40	the	the	DET
ihlr-18810	168	41	ide	ide	NOUN
ihlr-18810	168	42	nor	nor	CCONJ
ihlr-18810	168	43	the	the	DET
ihlr-18810	168	44	hde	hde	PROPN
ihlr-18810	168	45	exemptions	exemption	NOUN
ihlr-18810	168	46	will	will	AUX
ihlr-18810	168	47	be	be	AUX
ihlr-18810	168	48	addressed	address	VERB
ihlr-18810	168	49	further	far	ADV
ihlr-18810	168	50	in	in	ADP
ihlr-18810	168	51	this	this	DET
ihlr-18810	168	52	article	article	NOUN
ihlr-18810	168	53	.	.	PUNCT
ihlr-18810	169	1	a	a	DET
ihlr-18810	169	2	vast	vast	ADJ
ihlr-18810	169	3	majority	majority	NOUN
ihlr-18810	169	4	of	of	ADP
ihlr-18810	169	5	devices	device	NOUN
ihlr-18810	169	6	are	be	AUX
ihlr-18810	169	7	exempt	exempt	ADJ
ihlr-18810	169	8	from	from	ADP
ihlr-18810	169	9	the	the	DET
ihlr-18810	169	10	pma	pma	PROPN
ihlr-18810	169	11	approval	approval	NOUN
ihlr-18810	169	12	process	process	NOUN
ihlr-18810	169	13	through	through	ADP
ihlr-18810	169	14	something	something	PRON
ihlr-18810	169	15	known	know	VERB
ihlr-18810	169	16	as	as	ADP
ihlr-18810	169	17	§	§	PROPN
ihlr-18810	169	18	510(k	510(k	PROPN
ihlr-18810	169	19	)	)	PUNCT
ihlr-18810	169	20	premarket	premarket	NOUN
ihlr-18810	169	21	notification	notification	NOUN
ihlr-18810	169	22	.	.	PUNCT
ihlr-18810	170	1	56	56	NUM
ihlr-18810	170	2	the	the	DET
ihlr-18810	170	3	mda	mda	PROPN
ihlr-18810	170	4	grandfathered	grandfathere	VERB
ihlr-18810	170	5	in	in	ADP
ihlr-18810	170	6	any	any	DET
ihlr-18810	170	7	devices	device	NOUN
ihlr-18810	170	8	that	that	PRON
ihlr-18810	170	9	were	be	AUX
ihlr-18810	170	10	legally	legally	ADV
ihlr-18810	170	11	on	on	ADP
ihlr-18810	170	12	the	the	DET
ihlr-18810	170	13	market	market	NOUN
ihlr-18810	170	14	before	before	ADP
ihlr-18810	170	15	may	may	PROPN
ihlr-18810	170	16	28	28	NUM
ihlr-18810	170	17	,	,	PUNCT
ihlr-18810	170	18	197657	197657	NUM
ihlr-18810	170	19	and	and	CCONJ
ihlr-18810	170	20	also	also	ADV
ihlr-18810	170	21	permitted	permit	VERB
ihlr-18810	170	22	devices	device	NOUN
ihlr-18810	170	23	that	that	PRON
ihlr-18810	170	24	were	be	AUX
ihlr-18810	170	25	shown	show	VERB
ihlr-18810	170	26	to	to	PART
ihlr-18810	170	27	be	be	AUX
ihlr-18810	170	28	"	"	PUNCT
ihlr-18810	170	29	substantially	substantially	ADV
ihlr-18810	170	30	equivalent	equivalent	ADJ
ihlr-18810	170	31	"	"	PUNCT
ihlr-18810	170	32	to	to	ADP
ihlr-18810	170	33	these	these	DET
ihlr-18810	170	34	pre-1976	pre-1976	NOUN
ihlr-18810	170	35	devices58	devices58	NOUN
ihlr-18810	170	36	to	to	PART
ihlr-18810	170	37	avoid	avoid	VERB
ihlr-18810	170	38	the	the	DET
ihlr-18810	170	39	pma	pma	NOUN
ihlr-18810	170	40	process	process	NOUN
ihlr-18810	170	41	through	through	ADP
ihlr-18810	170	42	premarket	premarket	NOUN
ihlr-18810	170	43	notification	notification	NOUN
ihlr-18810	170	44	.	.	PUNCT
ihlr-18810	171	1	the	the	DET
ihlr-18810	171	2	manufacturer	manufacturer	NOUN
ihlr-18810	171	3	or	or	CCONJ
ihlr-18810	171	4	sponsor	sponsor	NOUN
ihlr-18810	171	5	of	of	ADP
ihlr-18810	171	6	the	the	DET
ihlr-18810	171	7	device	device	NOUN
ihlr-18810	171	8	must	must	AUX
ihlr-18810	171	9	receive	receive	VERB
ihlr-18810	171	10	an	an	DET
ihlr-18810	171	11	order	order	NOUN
ihlr-18810	171	12	from	from	ADP
ihlr-18810	171	13	the	the	DET
ihlr-18810	171	14	fda	fda	PROPN
ihlr-18810	171	15	finding	find	VERB
ihlr-18810	171	16	the	the	DET
ihlr-18810	171	17	device	device	NOUN
ihlr-18810	171	18	to	to	PART
ihlr-18810	171	19	be	be	AUX
ihlr-18810	171	20	substantially	substantially	ADV
ihlr-18810	171	21	51	51	NUM
ihlr-18810	171	22	burgos	burgo	NOUN
ihlr-18810	171	23	v.	v.	ADP
ihlr-18810	171	24	satiety	satiety	PROPN
ihlr-18810	171	25	,	,	PUNCT
ihlr-18810	171	26	inc	inc	PROPN
ihlr-18810	171	27	.	.	PROPN
ihlr-18810	171	28	,	,	PUNCT
ihlr-18810	171	29	no	no	INTJ
ihlr-18810	171	30	.	.	NOUN
ihlr-18810	171	31	10	10	NUM
ihlr-18810	171	32	-	-	PUNCT
ihlr-18810	171	33	cv-2680	cv-2680	ADJ
ihlr-18810	171	34	(	(	PUNCT
ihlr-18810	171	35	jg	jg	PROPN
ihlr-18810	171	36	)	)	PUNCT
ihlr-18810	171	37	,	,	PUNCT
ihlr-18810	171	38	2010	2010	NUM
ihlr-18810	171	39	wl	wl	NOUN
ihlr-18810	171	40	4907764	4907764	NUM
ihlr-18810	171	41	,	,	PUNCT
ihlr-18810	171	42	at	at	ADP
ihlr-18810	171	43	*	*	NOUN
ihlr-18810	171	44	2	2	NUM
ihlr-18810	171	45	(	(	PUNCT
ihlr-18810	171	46	e.d.n.y	e.d.n.y	PROPN
ihlr-18810	171	47	.	.	PUNCT
ihlr-18810	171	48	nov	nov	PROPN
ihlr-18810	171	49	.	.	PROPN
ihlr-18810	171	50	30	30	NUM
ihlr-18810	171	51	,	,	PUNCT
ihlr-18810	171	52	2010	2010	NUM
ihlr-18810	171	53	)	)	PUNCT
ihlr-18810	171	54	.	.	PUNCT
ihlr-18810	172	1	52	52	NUM
ihlr-18810	172	2	i	i	PROPN
ihlr-18810	172	3	d.	d.	PROPN
ihlr-18810	172	4	(	(	PUNCT
ihlr-18810	172	5	citing	cite	VERB
ihlr-18810	172	6	in	in	ADP
ihlr-18810	172	7	re	re	NOUN
ihlr-18810	172	8	orthopedic	orthopedic	ADJ
ihlr-18810	172	9	bone	bone	NOUN
ihlr-18810	172	10	screw	screw	NOUN
ihlr-18810	172	11	prods	prod	VERB
ihlr-18810	172	12	.	.	PUNCT
ihlr-18810	173	1	liab	liab	PROPN
ihlr-18810	173	2	.	.	PUNCT
ihlr-18810	174	1	litig	litig	PROPN
ihlr-18810	174	2	.	.	PUNCT
ihlr-18810	175	1	,	,	PUNCT
ihlr-18810	175	2	193	193	NUM
ihlr-18810	175	3	f.3d	f.3d	NUM
ihlr-18810	175	4	781	781	NUM
ihlr-18810	175	5	,	,	PUNCT
ihlr-18810	175	6	786	786	NUM
ihlr-18810	175	7	(	(	PUNCT
ihlr-18810	175	8	3d	3d	NOUN
ihlr-18810	175	9	cir.1999	cir.1999	NOUN
ihlr-18810	175	10	)	)	PUNCT
ihlr-18810	175	11	)	)	PUNCT
ihlr-18810	175	12	.	.	PUNCT
ihlr-18810	176	1	53	53	NUM
ihlr-18810	176	2	brennan	brennan	PROPN
ihlr-18810	176	3	,	,	PUNCT
ihlr-18810	176	4	supra	supra	PROPN
ihlr-18810	176	5	note	note	PROPN
ihlr-18810	176	6	45	45	NUM
ihlr-18810	176	7	,	,	PUNCT
ihlr-18810	176	8	at	at	ADP
ihlr-18810	176	9	144	144	NUM
ihlr-18810	176	10	.	.	PUNCT
ihlr-18810	176	11	54	54	NUM
ihlr-18810	177	1	i	i	PRON
ihlr-18810	177	2	d.	d.	PROPN
ihlr-18810	177	3	s	s	PROPN
ihlr-18810	178	1	i	i	PROPN
ihlr-18810	178	2	d.	d.	PROPN
ihlr-18810	178	3	56	56	NUM
ihlr-18810	178	4	jeffrey	jeffrey	PROPN
ihlr-18810	178	5	zigler	zigler	PROPN
ihlr-18810	178	6	et	et	PROPN
ihlr-18810	178	7	al	al	PROPN
ihlr-18810	178	8	.	.	PROPN
ihlr-18810	178	9	,	,	PUNCT
ihlr-18810	178	10	medical	medical	ADJ
ihlr-18810	178	11	device	device	NOUN
ihlr-18810	178	12	reporting	reporting	NOUN
ihlr-18810	178	13	:	:	PUNCT
ihlr-18810	178	14	issues	issue	NOUN
ihlr-18810	178	15	with	with	ADP
ihlr-18810	178	16	class	class	NOUN
ihlr-18810	178	17	iii	iii	NUM
ihlr-18810	178	18	medical	medical	ADJ
ihlr-18810	178	19	devices	device	NOUN
ihlr-18810	178	20	,	,	PUNCT
ihlr-18810	178	21	62	62	NUM
ihlr-18810	178	22	food	food	NOUN
ihlr-18810	178	23	&	&	CCONJ
ihlr-18810	178	24	drug	drug	PROPN
ihlr-18810	178	25	l.j	l.j	PROPN
ihlr-18810	178	26	.	.	PROPN
ihlr-18810	178	27	573	573	NUM
ihlr-18810	178	28	,	,	PUNCT
ihlr-18810	178	29	573	573	NUM
ihlr-18810	178	30	(	(	PUNCT
ihlr-18810	178	31	2007	2007	NUM
ihlr-18810	178	32	)	)	PUNCT
ihlr-18810	178	33	;	;	PUNCT
ihlr-18810	178	34	see	see	VERB
ihlr-18810	178	35	also	also	ADV
ihlr-18810	178	36	medtronic	medtronic	ADJ
ihlr-18810	178	37	,	,	PUNCT
ihlr-18810	178	38	inc	inc	PROPN
ihlr-18810	178	39	.	.	PROPN
ihlr-18810	179	1	v.	v.	PROPN
ihlr-18810	179	2	lohr	lohr	PROPN
ihlr-18810	179	3	,	,	PUNCT
ihlr-18810	179	4	518	518	NUM
ihlr-18810	179	5	u.s	u.s	PROPN
ihlr-18810	179	6	.	.	PROPN
ihlr-18810	179	7	470	470	NUM
ihlr-18810	179	8	,	,	PUNCT
ihlr-18810	179	9	479	479	NUM
ihlr-18810	179	10	(	(	PUNCT
ihlr-18810	179	11	1996	1996	NUM
ihlr-18810	179	12	)	)	PUNCT
ihlr-18810	179	13	.	.	PUNCT
ihlr-18810	180	1	57	57	NUM
ihlr-18810	180	2	21	21	NUM
ihlr-18810	180	3	u.s.c	u.s.c	NOUN
ihlr-18810	180	4	.	.	PUNCT
ihlr-18810	181	1	§	§	PROPN
ihlr-18810	181	2	360e(b)(1)(a	360e(b)(1)(a	NUM
ihlr-18810	181	3	)	)	PUNCT
ihlr-18810	181	4	(	(	PUNCT
ihlr-18810	181	5	2012	2012	NUM
ihlr-18810	181	6	)	)	PUNCT
ihlr-18810	181	7	.	.	PUNCT
ihlr-18810	182	1	58	58	NUM
ihlr-18810	182	2	21	21	NUM
ihlr-18810	182	3	u.s.c	u.s.c	NOUN
ihlr-18810	182	4	.	.	PUNCT
ihlr-18810	183	1	§	§	PROPN
ihlr-18810	183	2	360e(b)(1)(b	360e(b)(1)(b	PROPN
ihlr-18810	183	3	)	)	PUNCT
ihlr-18810	183	4	(	(	PUNCT
ihlr-18810	183	5	2012	2012	NUM
ihlr-18810	183	6	)	)	PUNCT
ihlr-18810	183	7	.	.	PUNCT
ihlr-18810	184	1	126	126	NUM
ihlr-18810	184	2	vol	vol	NOUN
ihlr-18810	184	3	.	.	PUNCT
ihlr-18810	185	1	10:1	10:1	NUM
ihlr-18810	185	2	510(k	510(k	X
ihlr-18810	185	3	)	)	PUNCT
ihlr-18810	185	4	clearance	clearance	NOUN
ihlr-18810	185	5	equivalent	equivalent	ADJ
ihlr-18810	185	6	to	to	ADP
ihlr-18810	185	7	a	a	DET
ihlr-18810	185	8	predicate	predicate	NOUN
ihlr-18810	185	9	device.59	device.59	NOUN
ihlr-18810	185	10	this	this	DET
ihlr-18810	185	11	order	order	NOUN
ihlr-18810	185	12	clears	clear	VERB
ihlr-18810	185	13	the	the	DET
ihlr-18810	185	14	device	device	NOUN
ihlr-18810	185	15	for	for	ADP
ihlr-18810	185	16	commercial	commercial	ADJ
ihlr-18810	185	17	distribution	distribution	NOUN
ihlr-18810	185	18	in	in	ADP
ihlr-18810	185	19	the	the	DET
ihlr-18810	185	20	u.s.60	u.s.60	NOUN
ihlr-18810	185	21	this	this	DET
ihlr-18810	185	22	510(k	510(k	NUM
ihlr-18810	185	23	)	)	PUNCT
ihlr-18810	185	24	process	process	NOUN
ihlr-18810	185	25	was	be	AUX
ihlr-18810	185	26	initially	initially	ADV
ihlr-18810	185	27	created	create	VERB
ihlr-18810	185	28	as	as	ADP
ihlr-18810	185	29	a	a	DET
ihlr-18810	185	30	way	way	NOUN
ihlr-18810	185	31	to	to	PART
ihlr-18810	185	32	keep	keep	VERB
ihlr-18810	185	33	the	the	DET
ihlr-18810	185	34	valuable	valuable	ADJ
ihlr-18810	185	35	medical	medical	ADJ
ihlr-18810	185	36	device	device	NOUN
ihlr-18810	185	37	products	product	NOUN
ihlr-18810	185	38	consumers	consumer	NOUN
ihlr-18810	185	39	had	have	AUX
ihlr-18810	185	40	used	use	VERB
ihlr-18810	185	41	for	for	ADP
ihlr-18810	185	42	years	year	NOUN
ihlr-18810	185	43	available	available	ADJ
ihlr-18810	185	44	on	on	ADP
ihlr-18810	185	45	the	the	DET
ihlr-18810	185	46	market	market	NOUN
ihlr-18810	185	47	,	,	PUNCT
ihlr-18810	185	48	and	and	CCONJ
ihlr-18810	185	49	to	to	PART
ihlr-18810	185	50	prevent	prevent	VERB
ihlr-18810	185	51	unfair	unfair	ADJ
ihlr-18810	185	52	monopolization	monopolization	NOUN
ihlr-18810	185	53	of	of	ADP
ihlr-18810	185	54	the	the	DET
ihlr-18810	185	55	marketplace	marketplace	NOUN
ihlr-18810	185	56	by	by	ADP
ihlr-18810	185	57	those	those	DET
ihlr-18810	185	58	manufacturers	manufacturer	NOUN
ihlr-18810	185	59	fortunate	fortunate	VERB
ihlr-18810	185	60	enough	enough	ADV
ihlr-18810	185	61	to	to	PART
ihlr-18810	185	62	get	get	VERB
ihlr-18810	185	63	their	their	PRON
ihlr-18810	185	64	products	product	NOUN
ihlr-18810	185	65	out	out	ADP
ihlr-18810	185	66	before	before	ADP
ihlr-18810	185	67	the	the	DET
ihlr-18810	185	68	enactment	enactment	NOUN
ihlr-18810	185	69	of	of	ADP
ihlr-18810	185	70	the	the	DET
ihlr-18810	185	71	mda	mda	PROPN
ihlr-18810	185	72	.	.	PUNCT
ihlr-18810	186	1	however	however	ADV
ihlr-18810	186	2	,	,	PUNCT
ihlr-18810	186	3	the	the	DET
ihlr-18810	186	4	review	review	NOUN
ihlr-18810	186	5	process	process	NOUN
ihlr-18810	186	6	has	have	AUX
ihlr-18810	186	7	taken	take	VERB
ihlr-18810	186	8	a	a	DET
ihlr-18810	186	9	very	very	ADV
ihlr-18810	186	10	different	different	ADJ
ihlr-18810	186	11	form	form	NOUN
ihlr-18810	186	12	today	today	NOUN
ihlr-18810	186	13	.	.	PUNCT
ihlr-18810	187	1	only	only	ADV
ihlr-18810	187	2	conceptually	conceptually	ADV
ihlr-18810	187	3	new	new	ADJ
ihlr-18810	187	4	devices	device	NOUN
ihlr-18810	187	5	marketed	market	VERB
ihlr-18810	187	6	since	since	SCONJ
ihlr-18810	187	7	1976	1976	NUM
ihlr-18810	187	8	have	have	AUX
ihlr-18810	187	9	been	be	AUX
ihlr-18810	187	10	required	require	VERB
ihlr-18810	187	11	to	to	PART
ihlr-18810	187	12	undergo	undergo	VERB
ihlr-18810	187	13	rigorous	rigorous	ADJ
ihlr-18810	187	14	scientific	scientific	ADJ
ihlr-18810	187	15	demonstration	demonstration	NOUN
ihlr-18810	187	16	of	of	ADP
ihlr-18810	187	17	safety	safety	NOUN
ihlr-18810	187	18	and	and	CCONJ
ihlr-18810	187	19	efficacy.6	efficacy.6	PROPN
ihlr-18810	187	20	'	'	PUNCT
ihlr-18810	187	21	section	section	NOUN
ihlr-18810	187	22	510(k	510(k	NUM
ihlr-18810	187	23	)	)	PUNCT
ihlr-18810	187	24	review	review	NOUN
ihlr-18810	187	25	requires	require	VERB
ihlr-18810	187	26	the	the	DET
ihlr-18810	187	27	submission	submission	NOUN
ihlr-18810	187	28	of	of	ADP
ihlr-18810	187	29	comparably	comparably	ADV
ihlr-18810	187	30	little	little	ADJ
ihlr-18810	187	31	information	information	NOUN
ihlr-18810	187	32	on	on	ADP
ihlr-18810	187	33	the	the	DET
ihlr-18810	187	34	device	device	NOUN
ihlr-18810	187	35	,	,	PUNCT
ihlr-18810	187	36	and	and	CCONJ
ihlr-18810	187	37	the	the	DET
ihlr-18810	187	38	review	review	NOUN
ihlr-18810	187	39	is	be	AUX
ihlr-18810	187	40	usually	usually	ADV
ihlr-18810	187	41	completed	complete	VERB
ihlr-18810	187	42	by	by	ADP
ihlr-18810	187	43	the	the	DET
ihlr-18810	187	44	fda	fda	PROPN
ihlr-18810	187	45	in	in	ADP
ihlr-18810	187	46	twenty	twenty	NUM
ihlr-18810	187	47	hours.62	hours.62	NOUN
ihlr-18810	187	48	the	the	DET
ihlr-18810	187	49	concept	concept	NOUN
ihlr-18810	187	50	of	of	ADP
ihlr-18810	187	51	substantial	substantial	ADJ
ihlr-18810	187	52	equivalence	equivalence	NOUN
ihlr-18810	187	53	is	be	AUX
ihlr-18810	187	54	central	central	ADJ
ihlr-18810	187	55	to	to	ADP
ihlr-18810	187	56	the	the	DET
ihlr-18810	187	57	510(k	510(k	PROPN
ihlr-18810	187	58	)	)	PUNCT
ihlr-18810	187	59	clearance	clearance	NOUN
ihlr-18810	187	60	process	process	NOUN
ihlr-18810	187	61	.	.	PUNCT
ihlr-18810	188	1	when	when	SCONJ
ihlr-18810	188	2	the	the	DET
ihlr-18810	188	3	premarket	premarket	NOUN
ihlr-18810	188	4	notification	notification	NOUN
ihlr-18810	188	5	was	be	AUX
ihlr-18810	188	6	first	first	ADV
ihlr-18810	188	7	created	create	VERB
ihlr-18810	188	8	,	,	PUNCT
ihlr-18810	188	9	the	the	DET
ihlr-18810	188	10	fda	fda	PROPN
ihlr-18810	188	11	intended	intend	VERB
ihlr-18810	188	12	to	to	PART
ihlr-18810	188	13	ensure	ensure	VERB
ihlr-18810	188	14	new	new	ADJ
ihlr-18810	188	15	devices	device	NOUN
ihlr-18810	188	16	cleared	clear	VERB
ihlr-18810	188	17	for	for	ADP
ihlr-18810	188	18	marketing	marketing	NOUN
ihlr-18810	188	19	through	through	ADP
ihlr-18810	188	20	this	this	DET
ihlr-18810	188	21	process	process	NOUN
ihlr-18810	188	22	did	do	AUX
ihlr-18810	188	23	not	not	PART
ihlr-18810	188	24	differ	differ	VERB
ihlr-18810	188	25	from	from	ADP
ihlr-18810	188	26	their	their	PRON
ihlr-18810	188	27	predicate	predicate	NOUN
ihlr-18810	188	28	devices	device	NOUN
ihlr-18810	188	29	in	in	ADP
ihlr-18810	188	30	a	a	DET
ihlr-18810	188	31	way	way	NOUN
ihlr-18810	188	32	that	that	PRON
ihlr-18810	188	33	had	have	VERB
ihlr-18810	188	34	an	an	DET
ihlr-18810	188	35	effect	effect	NOUN
ihlr-18810	188	36	on	on	ADP
ihlr-18810	188	37	59	59	NUM
ihlr-18810	188	38	a	a	DET
ihlr-18810	188	39	predicate	predicate	NOUN
ihlr-18810	188	40	device	device	NOUN
ihlr-18810	188	41	is	be	AUX
ihlr-18810	188	42	"	"	PUNCT
ihlr-18810	188	43	a	a	DET
ihlr-18810	188	44	legally	legally	ADV
ihlr-18810	188	45	marketed	market	VERB
ihlr-18810	188	46	device	device	NOUN
ihlr-18810	188	47	.	.	PUNCT
ihlr-18810	188	48	.	.	PUNCT
ihlr-18810	188	49	.	.	PUNCT
ihlr-18810	189	1	that	that	PRON
ihlr-18810	189	2	is	be	AUX
ihlr-18810	189	3	not	not	PART
ihlr-18810	189	4	subject	subject	ADJ
ihlr-18810	189	5	to	to	ADP
ihlr-18810	189	6	premarket	premarket	ADJ
ihlr-18810	189	7	approval	approval	NOUN
ihlr-18810	189	8	(	(	PUNCT
ihlr-18810	189	9	pma	pma	NOUN
ihlr-18810	189	10	)	)	PUNCT
ihlr-18810	189	11	.	.	PUNCT
ihlr-18810	189	12	"	"	PUNCT
ihlr-18810	190	1	fda	fda	PROPN
ihlr-18810	190	2	,	,	PUNCT
ihlr-18810	190	3	how	how	SCONJ
ihlr-18810	190	4	to	to	PART
ihlr-18810	190	5	find	find	VERB
ihlr-18810	190	6	a	a	DET
ihlr-18810	190	7	predicate	predicate	NOUN
ihlr-18810	190	8	device	device	NOUN
ihlr-18810	190	9	,	,	PUNCT
ihlr-18810	190	10	http://www.fda.gov/medicaldevices/deviceregulationand	http://www.fda.gov/medicaldevices/deviceregulationand	ADP
ihlr-18810	190	11	guidance	guidance	NOUN
ihlr-18810	190	12	/	/	SYM
ihlr-18810	190	13	howtomarketyourdevice	howtomarketyourdevice	NOUN
ihlr-18810	190	14	/	/	SYM
ihlr-18810	190	15	premarketsubmissions	premarketsubmission	NOUN
ihlr-18810	190	16	/	/	SYM
ihlr-18810	190	17	premarket	premarket	NOUN
ihlr-18810	190	18	notification510klucm134571.htm	notification510klucm134571.htm	PROPN
ihlr-18810	190	19	.	.	PUNCT
ihlr-18810	191	1	60	60	NUM
ihlr-18810	191	2	medical	medical	ADJ
ihlr-18810	191	3	devices	device	NOUN
ihlr-18810	191	4	:	:	PUNCT
ihlr-18810	191	5	premarket	premarket	NOUN
ihlr-18810	191	6	notification	notification	NOUN
ihlr-18810	191	7	(	(	PUNCT
ihlr-18810	191	8	501(k	501(k	PROPN
ihlr-18810	191	9	)	)	PUNCT
ihlr-18810	191	10	)	)	PUNCT
ihlr-18810	191	11	,	,	PUNCT
ihlr-18810	191	12	u.s	u.s	PROPN
ihlr-18810	191	13	.	.	PROPN
ihlr-18810	191	14	food	food	NOUN
ihlr-18810	191	15	and	and	CCONJ
ihlr-18810	191	16	drug	drug	NOUN
ihlr-18810	191	17	admin	admin	PROPN
ihlr-18810	191	18	.	.	PUNCT
ihlr-18810	191	19	,	,	PUNCT
ihlr-18810	191	20	http://www.fda.gov/medicaldevices/deviceregulation	http://www.fda.gov/medicaldevices/deviceregulation	NOUN
ihlr-18810	191	21	andguidance	andguidance	NOUN
ihlr-18810	191	22	/	/	SYM
ihlr-18810	191	23	howtomarketyourdevice	howtomarketyourdevice	NOUN
ihlr-18810	191	24	/	/	SYM
ihlr-18810	191	25	premarketsubmissions	premarketsubmission	NOUN
ihlr-18810	191	26	/	/	SYM
ihlr-18810	191	27	premarket	premarket	NOUN
ihlr-18810	191	28	notification5lok	notification5lok	NOUN
ihlr-18810	191	29	/	/	SYM
ihlr-18810	191	30	default.htm	default.htm	X
ihlr-18810	191	31	(	(	PUNCT
ihlr-18810	191	32	last	last	ADV
ihlr-18810	191	33	visited	visit	VERB
ihlr-18810	191	34	nov	nov	PROPN
ihlr-18810	191	35	.	.	PROPN
ihlr-18810	191	36	26	26	NUM
ihlr-18810	191	37	,	,	PUNCT
ihlr-18810	191	38	2012	2012	NUM
ihlr-18810	191	39	)	)	PUNCT
ihlr-18810	191	40	.	.	PUNCT
ihlr-18810	192	1	61	61	NUM
ihlr-18810	192	2	zigler	zigler	NOUN
ihlr-18810	192	3	,	,	PUNCT
ihlr-18810	192	4	supra	supra	PROPN
ihlr-18810	192	5	note	note	PROPN
ihlr-18810	192	6	56	56	NUM
ihlr-18810	192	7	,	,	PUNCT
ihlr-18810	192	8	at	at	ADP
ihlr-18810	192	9	573	573	NUM
ihlr-18810	192	10	.	.	PUNCT
ihlr-18810	193	1	in	in	ADP
ihlr-18810	193	2	2007	2007	NUM
ihlr-18810	193	3	,	,	PUNCT
ihlr-18810	193	4	the	the	DET
ihlr-18810	193	5	government	government	NOUN
ihlr-18810	193	6	accountability	accountability	NOUN
ihlr-18810	193	7	office	office	NOUN
ihlr-18810	193	8	(	(	PUNCT
ihlr-18810	193	9	gao	gao	PROPN
ihlr-18810	193	10	)	)	PUNCT
ihlr-18810	193	11	began	begin	VERB
ihlr-18810	193	12	a	a	DET
ihlr-18810	193	13	study	study	NOUN
ihlr-18810	193	14	to	to	PART
ihlr-18810	193	15	determine	determine	VERB
ihlr-18810	193	16	which	which	DET
ihlr-18810	193	17	review	review	NOUN
ihlr-18810	193	18	process	process	NOUN
ihlr-18810	193	19	,	,	PUNCT
ihlr-18810	193	20	510(k	510(k	NUM
ihlr-18810	193	21	)	)	PUNCT
ihlr-18810	193	22	or	or	CCONJ
ihlr-18810	193	23	pma	pma	NOUN
ihlr-18810	193	24	,	,	PUNCT
ihlr-18810	193	25	was	be	AUX
ihlr-18810	193	26	used	use	VERB
ihlr-18810	193	27	by	by	ADP
ihlr-18810	193	28	the	the	DET
ihlr-18810	193	29	fda	fda	PROPN
ihlr-18810	193	30	to	to	PART
ihlr-18810	193	31	review	review	VERB
ihlr-18810	193	32	different	different	ADJ
ihlr-18810	193	33	types	type	NOUN
ihlr-18810	193	34	of	of	ADP
ihlr-18810	193	35	device	device	NOUN
ihlr-18810	193	36	submissions	submission	NOUN
ihlr-18810	193	37	.	.	PUNCT
ihlr-18810	194	1	u.s	u.s	PROPN
ihlr-18810	194	2	.	.	PROPN
ihlr-18810	194	3	gov't	gov't	PROPN
ihlr-18810	194	4	accountability	accountability	NOUN
ihlr-18810	194	5	office	office	NOUN
ihlr-18810	194	6	,	,	PUNCT
ihlr-18810	194	7	gao-09	gao-09	PROPN
ihlr-18810	194	8	-	-	PUNCT
ihlr-18810	194	9	190	190	NUM
ihlr-18810	194	10	,	,	PUNCT
ihlr-18810	194	11	medical	medical	ADJ
ihlr-18810	194	12	devices	device	NOUN
ihlr-18810	194	13	:	:	PUNCT
ihlr-18810	194	14	fda	fda	PROPN
ihlr-18810	194	15	should	should	AUX
ihlr-18810	194	16	take	take	VERB
ihlr-18810	194	17	steps	step	NOUN
ihlr-18810	194	18	to	to	PART
ihlr-18810	194	19	ensure	ensure	VERB
ihlr-18810	194	20	that	that	SCONJ
ihlr-18810	194	21	highrisk	highrisk	NOUN
ihlr-18810	194	22	device	device	NOUN
ihlr-18810	194	23	types	type	NOUN
ihlr-18810	194	24	are	be	AUX
ihlr-18810	194	25	approved	approve	VERB
ihlr-18810	194	26	through	through	ADP
ihlr-18810	194	27	the	the	DET
ihlr-18810	194	28	most	most	ADV
ihlr-18810	194	29	stringent	stringent	ADJ
ihlr-18810	194	30	premarket	premarket	NOUN
ihlr-18810	194	31	review	review	NOUN
ihlr-18810	194	32	process	process	NOUN
ihlr-18810	194	33	4	4	NUM
ihlr-18810	194	34	(	(	PUNCT
ihlr-18810	194	35	2009	2009	NUM
ihlr-18810	194	36	)	)	PUNCT
ihlr-18810	194	37	.	.	PUNCT
ihlr-18810	195	1	the	the	DET
ihlr-18810	195	2	gao	gao	PROPN
ihlr-18810	195	3	found	find	VERB
ihlr-18810	195	4	that	that	SCONJ
ihlr-18810	195	5	,	,	PUNCT
ihlr-18810	195	6	from	from	ADP
ihlr-18810	195	7	2003	2003	NUM
ihlr-18810	195	8	to	to	ADP
ihlr-18810	195	9	2007	2007	NUM
ihlr-18810	195	10	,	,	PUNCT
ihlr-18810	195	11	the	the	DET
ihlr-18810	195	12	fda	fda	PROPN
ihlr-18810	195	13	reviewed	review	VERB
ihlr-18810	195	14	13,199	13,199	NUM
ihlr-18810	195	15	submissions	submission	NOUN
ihlr-18810	195	16	for	for	ADP
ihlr-18810	195	17	class	class	NOUN
ihlr-18810	195	18	i	i	PROPN
ihlr-18810	195	19	and	and	CCONJ
ihlr-18810	195	20	ii	ii	PROPN
ihlr-18810	195	21	devices	device	NOUN
ihlr-18810	195	22	through	through	ADP
ihlr-18810	195	23	the	the	DET
ihlr-18810	195	24	510(k	510(k	PROPN
ihlr-18810	195	25	)	)	PUNCT
ihlr-18810	195	26	process	process	NOUN
ihlr-18810	195	27	and	and	CCONJ
ihlr-18810	195	28	cleared	clear	VERB
ihlr-18810	195	29	90	90	NUM
ihlr-18810	195	30	percent	percent	NOUN
ihlr-18810	195	31	.	.	PUNCT
ihlr-18810	196	1	i	i	PRON
ihlr-18810	196	2	d.	d.	PROPN
ihlr-18810	196	3	at	at	ADP
ihlr-18810	196	4	6	6	NUM
ihlr-18810	196	5	.	.	PUNCT
ihlr-18810	197	1	the	the	DET
ihlr-18810	197	2	fda	fda	PROPN
ihlr-18810	197	3	also	also	ADV
ihlr-18810	197	4	reviewed	review	VERB
ihlr-18810	197	5	342	342	NUM
ihlr-18810	197	6	510(k	510(k	NUM
ihlr-18810	197	7	)	)	PUNCT
ihlr-18810	197	8	submissions	submission	NOUN
ihlr-18810	197	9	for	for	ADP
ihlr-18810	197	10	class	class	NOUN
ihlr-18810	197	11	iii	iii	NUM
ihlr-18810	197	12	devices	device	NOUN
ihlr-18810	197	13	,	,	PUNCT
ihlr-18810	197	14	and	and	CCONJ
ihlr-18810	197	15	cleared	clear	VERB
ihlr-18810	197	16	67	67	NUM
ihlr-18810	197	17	percent	percent	NOUN
ihlr-18810	197	18	of	of	ADP
ihlr-18810	197	19	these	these	PRON
ihlr-18810	197	20	.	.	PUNCT
ihlr-18810	198	1	i	i	PRON
ihlr-18810	198	2	d.	d.	PROPN
ihlr-18810	198	3	in	in	ADP
ihlr-18810	198	4	contrast	contrast	NOUN
ihlr-18810	198	5	,	,	PUNCT
ihlr-18810	198	6	217	217	NUM
ihlr-18810	198	7	original	original	ADJ
ihlr-18810	198	8	and	and	CCONJ
ihlr-18810	198	9	784	784	NUM
ihlr-18810	198	10	supplemental	supplemental	ADJ
ihlr-18810	198	11	submissions	submission	NOUN
ihlr-18810	198	12	for	for	ADP
ihlr-18810	198	13	class	class	NOUN
ihlr-18810	198	14	iii	iii	NOUN
ihlr-18810	198	15	devices	device	NOUN
ihlr-18810	198	16	were	be	AUX
ihlr-18810	198	17	reviewed	review	VERB
ihlr-18810	198	18	through	through	ADP
ihlr-18810	198	19	the	the	DET
ihlr-18810	198	20	pma	pma	NOUN
ihlr-18810	198	21	process	process	NOUN
ihlr-18810	198	22	,	,	PUNCT
ihlr-18810	198	23	and	and	CCONJ
ihlr-18810	198	24	78	78	NUM
ihlr-18810	198	25	and	and	CCONJ
ihlr-18810	198	26	85	85	NUM
ihlr-18810	198	27	percent	percent	NOUN
ihlr-18810	198	28	,	,	PUNCT
ihlr-18810	198	29	respectively	respectively	ADV
ihlr-18810	198	30	,	,	PUNCT
ihlr-18810	198	31	of	of	ADP
ihlr-18810	198	32	these	these	DET
ihlr-18810	198	33	sub	sub	NOUN
ihlr-18810	198	34	-	-	NOUN
ihlr-18810	198	35	missions	mission	NOUN
ihlr-18810	198	36	were	be	AUX
ihlr-18810	198	37	approved	approve	VERB
ihlr-18810	198	38	.	.	PUNCT
ihlr-18810	199	1	i	i	PRON
ihlr-18810	199	2	d.	d.	PROPN
ihlr-18810	199	3	62	62	NUM
ihlr-18810	199	4	medtronic	medtronic	PROPN
ihlr-18810	199	5	,	,	PUNCT
ihlr-18810	199	6	inc	inc	PROPN
ihlr-18810	199	7	.	.	PROPN
ihlr-18810	199	8	v.	v.	PROPN
ihlr-18810	199	9	lohr	lohr	PROPN
ihlr-18810	199	10	,	,	PUNCT
ihlr-18810	199	11	518	518	NUM
ihlr-18810	199	12	u.s	u.s	PROPN
ihlr-18810	199	13	.	.	PROPN
ihlr-18810	199	14	470	470	NUM
ihlr-18810	199	15	,	,	PUNCT
ihlr-18810	199	16	479	479	NUM
ihlr-18810	199	17	(	(	PUNCT
ihlr-18810	199	18	1996	1996	NUM
ihlr-18810	199	19	)	)	PUNCT
ihlr-18810	199	20	.	.	PUNCT
ihlr-18810	200	1	2013	2013	NUM
ihlr-18810	200	2	127	127	NUM
ihlr-18810	200	3	indiana	indiana	PROPN
ihlr-18810	200	4	health	health	PROPN
ihlr-18810	200	5	law	law	PROPN
ihlr-18810	200	6	review	review	VERB
ihlr-18810	200	7	the	the	DET
ihlr-18810	200	8	safety	safety	NOUN
ihlr-18810	200	9	or	or	CCONJ
ihlr-18810	200	10	efficacy	efficacy	NOUN
ihlr-18810	200	11	of	of	ADP
ihlr-18810	200	12	the	the	DET
ihlr-18810	200	13	device	device	NOUN
ihlr-18810	200	14	.	.	PUNCT
ihlr-18810	201	1	in	in	ADP
ihlr-18810	201	2	a	a	DET
ihlr-18810	201	3	guidance	guidance	NOUN
ihlr-18810	201	4	issued	issue	VERB
ihlr-18810	201	5	by	by	ADP
ihlr-18810	201	6	the	the	DET
ihlr-18810	201	7	fda	fda	PROPN
ihlr-18810	201	8	,	,	PUNCT
ihlr-18810	201	9	the	the	DET
ihlr-18810	201	10	concept	concept	NOUN
ihlr-18810	201	11	was	be	AUX
ihlr-18810	201	12	described	describe	VERB
ihlr-18810	201	13	as	as	SCONJ
ihlr-18810	201	14	follows	follow	VERB
ihlr-18810	201	15	:	:	PUNCT
ihlr-18810	201	16	the	the	DET
ihlr-18810	201	17	term	term	NOUN
ihlr-18810	201	18	"	"	PUNCT
ihlr-18810	201	19	substantially	substantially	ADV
ihlr-18810	201	20	equivalent	equivalent	ADJ
ihlr-18810	201	21	"	"	PUNCT
ihlr-18810	201	22	is	be	AUX
ihlr-18810	201	23	not	not	PART
ihlr-18810	201	24	intended	intend	VERB
ihlr-18810	201	25	to	to	PART
ihlr-18810	201	26	be	be	AUX
ihlr-18810	201	27	so	so	ADV
ihlr-18810	201	28	narrow	narrow	ADJ
ihlr-18810	201	29	as	as	SCONJ
ihlr-18810	201	30	to	to	PART
ihlr-18810	201	31	refer	refer	VERB
ihlr-18810	201	32	only	only	ADV
ihlr-18810	201	33	to	to	ADP
ihlr-18810	201	34	devices	device	NOUN
ihlr-18810	201	35	that	that	PRON
ihlr-18810	201	36	are	be	AUX
ihlr-18810	201	37	identical	identical	ADJ
ihlr-18810	201	38	to	to	ADP
ihlr-18810	201	39	marketed	market	VERB
ihlr-18810	201	40	devices	device	NOUN
ihlr-18810	201	41	nor	nor	CCONJ
ihlr-18810	201	42	so	so	ADV
ihlr-18810	201	43	broad	broad	ADJ
ihlr-18810	201	44	as	as	SCONJ
ihlr-18810	201	45	to	to	PART
ihlr-18810	201	46	refer	refer	VERB
ihlr-18810	201	47	to	to	ADP
ihlr-18810	201	48	devices	device	NOUN
ihlr-18810	201	49	which	which	PRON
ihlr-18810	201	50	are	be	AUX
ihlr-18810	201	51	intended	intend	VERB
ihlr-18810	201	52	to	to	PART
ihlr-18810	201	53	be	be	AUX
ihlr-18810	201	54	used	use	VERB
ihlr-18810	201	55	for	for	ADP
ihlr-18810	201	56	the	the	DET
ihlr-18810	201	57	same	same	ADJ
ihlr-18810	201	58	purposes	purpose	NOUN
ihlr-18810	201	59	as	as	ADP
ihlr-18810	201	60	marketed	market	VERB
ihlr-18810	201	61	products	product	NOUN
ihlr-18810	201	62	.	.	PUNCT
ihlr-18810	202	1	the	the	DET
ihlr-18810	202	2	committee	committee	NOUN
ihlr-18810	202	3	believes	believe	VERB
ihlr-18810	202	4	that	that	SCONJ
ihlr-18810	202	5	the	the	DET
ihlr-18810	202	6	term	term	NOUN
ihlr-18810	202	7	should	should	AUX
ihlr-18810	202	8	be	be	AUX
ihlr-18810	202	9	construed	construe	VERB
ihlr-18810	202	10	narrowly	narrowly	ADV
ihlr-18810	202	11	where	where	SCONJ
ihlr-18810	202	12	necessary	necessary	ADJ
ihlr-18810	202	13	to	to	PART
ihlr-18810	202	14	assure	assure	VERB
ihlr-18810	202	15	the	the	DET
ihlr-18810	202	16	safety	safety	NOUN
ihlr-18810	202	17	and	and	CCONJ
ihlr-18810	202	18	effectiveness	effectiveness	NOUN
ihlr-18810	202	19	of	of	ADP
ihlr-18810	202	20	a	a	DET
ihlr-18810	202	21	device	device	NOUN
ihlr-18810	202	22	but	but	CCONJ
ihlr-18810	202	23	not	not	PART
ihlr-18810	202	24	narrowly	narrowly	ADV
ihlr-18810	202	25	where	where	SCONJ
ihlr-18810	202	26	differences	difference	NOUN
ihlr-18810	202	27	between	between	ADP
ihlr-18810	202	28	a	a	DET
ihlr-18810	202	29	new	new	ADJ
ihlr-18810	202	30	device	device	NOUN
ihlr-18810	202	31	and	and	CCONJ
ihlr-18810	202	32	a	a	DET
ihlr-18810	202	33	marketed	market	VERB
ihlr-18810	202	34	device	device	NOUN
ihlr-18810	202	35	do	do	AUX
ihlr-18810	202	36	not	not	PART
ihlr-18810	202	37	relate	relate	VERB
ihlr-18810	202	38	to	to	ADP
ihlr-18810	202	39	safety	safety	NOUN
ihlr-18810	202	40	and	and	CCONJ
ihlr-18810	202	41	effectiveness	effectiveness	NOUN
ihlr-18810	202	42	.	.	PUNCT
ihlr-18810	203	1	thus	thus	ADV
ihlr-18810	203	2	,	,	PUNCT
ihlr-18810	203	3	differences	difference	NOUN
ihlr-18810	203	4	between	between	ADP
ihlr-18810	203	5	"	"	PUNCT
ihlr-18810	203	6	new	new	ADJ
ihlr-18810	203	7	"	"	PUNCT
ihlr-18810	203	8	and	and	CCONJ
ihlr-18810	203	9	marketed	market	VERB
ihlr-18810	203	10	devices	device	NOUN
ihlr-18810	203	11	in	in	ADP
ihlr-18810	203	12	materials	material	NOUN
ihlr-18810	203	13	,	,	PUNCT
ihlr-18810	203	14	design	design	NOUN
ihlr-18810	203	15	,	,	PUNCT
ihlr-18810	203	16	or	or	CCONJ
ihlr-18810	203	17	energy	energy	NOUN
ihlr-18810	203	18	source	source	NOUN
ihlr-18810	203	19	,	,	PUNCT
ihlr-18810	203	20	for	for	ADP
ihlr-18810	203	21	example	example	NOUN
ihlr-18810	203	22	,	,	PUNCT
ihlr-18810	203	23	would	would	AUX
ihlr-18810	203	24	have	have	VERB
ihlr-18810	203	25	a	a	DET
ihlr-18810	203	26	b[e]aring	b[e]aring	NOUN
ihlr-18810	203	27	on	on	ADP
ihlr-18810	203	28	the	the	DET
ihlr-18810	203	29	adequacy	adequacy	NOUN
ihlr-18810	203	30	of	of	ADP
ihlr-18810	203	31	information	information	NOUN
ihlr-18810	203	32	as	as	ADP
ihlr-18810	203	33	to	to	ADP
ihlr-18810	203	34	a	a	DET
ihlr-18810	203	35	new	new	ADJ
ihlr-18810	203	36	device	device	NOUN
ihlr-18810	203	37	's	's	PART
ihlr-18810	203	38	safety	safety	NOUN
ihlr-18810	203	39	and	and	CCONJ
ihlr-18810	203	40	effectiveness	effectiveness	NOUN
ihlr-18810	203	41	,	,	PUNCT
ihlr-18810	203	42	and	and	CCONJ
ihlr-18810	203	43	such	such	ADJ
ihlr-18810	203	44	devices	device	NOUN
ihlr-18810	203	45	should	should	AUX
ihlr-18810	203	46	be	be	AUX
ihlr-18810	203	47	automatically	automatically	ADV
ihlr-18810	203	48	classified	classify	VERB
ihlr-18810	203	49	into	into	ADP
ihlr-18810	203	50	class	class	PROPN
ihlr-18810	203	51	iii	iii	PROPN
ihlr-18810	203	52	.	.	PUNCT
ihlr-18810	204	1	on	on	ADP
ihlr-18810	204	2	the	the	DET
ihlr-18810	204	3	other	other	ADJ
ihlr-18810	204	4	hand	hand	NOUN
ihlr-18810	204	5	,	,	PUNCT
ihlr-18810	204	6	copies	copy	NOUN
ihlr-18810	204	7	of	of	ADP
ihlr-18810	204	8	devices	device	NOUN
ihlr-18810	204	9	marketed	market	VERB
ihlr-18810	204	10	prior	prior	ADV
ihlr-18810	204	11	to	to	ADP
ihlr-18810	204	12	enactment	enactment	NOUN
ihlr-18810	204	13	,	,	PUNCT
ihlr-18810	204	14	or	or	CCONJ
ihlr-18810	204	15	devices	device	NOUN
ihlr-18810	204	16	whose	whose	DET
ihlr-18810	204	17	variations	variation	NOUN
ihlr-18810	204	18	are	be	AUX
ihlr-18810	204	19	immaterial	immaterial	ADJ
ihlr-18810	204	20	to	to	ADP
ihlr-18810	204	21	safety	safety	NOUN
ihlr-18810	204	22	and	and	CCONJ
ihlr-18810	204	23	effectiveness	effectiveness	NOUN
ihlr-18810	204	24	would	would	AUX
ihlr-18810	204	25	not	not	PART
ihlr-18810	204	26	necessarily	necessarily	ADV
ihlr-18810	204	27	fall	fall	VERB
ihlr-18810	204	28	under	under	ADP
ihlr-18810	204	29	the	the	DET
ihlr-18810	204	30	automatic	automatic	ADJ
ihlr-18810	204	31	classification	classification	NOUN
ihlr-18810	204	32	scheme	scheme	NOUN
ihlr-18810	204	33	.	.	PUNCT
ihlr-18810	205	1	63	63	NUM
ihlr-18810	205	2	as	as	SCONJ
ihlr-18810	205	3	codified	codify	VERB
ihlr-18810	205	4	in	in	ADP
ihlr-18810	205	5	the	the	DET
ihlr-18810	205	6	u.s	u.s	PROPN
ihlr-18810	205	7	.	.	PROPN
ihlr-18810	205	8	code	code	PROPN
ihlr-18810	205	9	,	,	PUNCT
ihlr-18810	205	10	substantial	substantial	ADJ
ihlr-18810	205	11	equivalence	equivalence	NOUN
ihlr-18810	205	12	means	mean	VERB
ihlr-18810	205	13	that	that	SCONJ
ihlr-18810	205	14	either	either	CCONJ
ihlr-18810	205	15	the	the	DET
ihlr-18810	205	16	device	device	NOUN
ihlr-18810	205	17	has	have	VERB
ihlr-18810	205	18	the	the	DET
ihlr-18810	205	19	same	same	ADJ
ihlr-18810	205	20	technological	technological	ADJ
ihlr-18810	205	21	characteristics64	characteristics64	NOUN
ihlr-18810	205	22	as	as	ADP
ihlr-18810	205	23	the	the	DET
ihlr-18810	205	24	predicate	predicate	NOUN
ihlr-18810	205	25	device	device	NOUN
ihlr-18810	205	26	,	,	PUNCT
ihlr-18810	205	27	or	or	CCONJ
ihlr-18810	205	28	the	the	DET
ihlr-18810	205	29	device	device	NOUN
ihlr-18810	205	30	has	have	VERB
ihlr-18810	205	31	63	63	NUM
ihlr-18810	205	32	guidance	guidance	NOUN
ihlr-18810	205	33	on	on	ADP
ihlr-18810	205	34	the	the	DET
ihlr-18810	205	35	cdrh	cdrh	ADJ
ihlr-18810	205	36	premarket	premarket	NOUN
ihlr-18810	205	37	notification	notification	NOUN
ihlr-18810	205	38	review	review	NOUN
ihlr-18810	205	39	program	program	NOUN
ihlr-18810	205	40	,	,	PUNCT
ihlr-18810	205	41	u.s	u.s	PROPN
ihlr-18810	205	42	.	.	PROPN
ihlr-18810	205	43	food	food	NOUN
ihlr-18810	205	44	and	and	CCONJ
ihlr-18810	205	45	drug	drug	NOUN
ihlr-18810	205	46	admin	admin	PROPN
ihlr-18810	205	47	.	.	PUNCT
ihlr-18810	205	48	,	,	PUNCT
ihlr-18810	205	49	http://www.fda.gov/	http://www.fda.gov/	PROPN
ihlr-18810	205	50	medicaldevices	medicaldevice	NOUN
ihlr-18810	205	51	/	/	SYM
ihlr-18810	205	52	deviceregulationandguidance	deviceregulationandguidance	PROPN
ihlr-18810	205	53	/	/	SYM
ihlr-18810	205	54	guidancedocuments/	guidancedocuments/	PROPN
ihlr-18810	205	55	ucm081383.htm	ucm081383.htm	PROPN
ihlr-18810	205	56	(	(	PUNCT
ihlr-18810	205	57	last	last	ADV
ihlr-18810	205	58	visited	visit	VERB
ihlr-18810	205	59	nov	nov	PROPN
ihlr-18810	205	60	.	.	PROPN
ihlr-18810	205	61	25	25	NUM
ihlr-18810	205	62	,	,	PUNCT
ihlr-18810	205	63	2012	2012	NUM
ihlr-18810	205	64	)	)	PUNCT
ihlr-18810	205	65	(	(	PUNCT
ihlr-18810	205	66	quoting	quote	VERB
ihlr-18810	205	67	h.r	h.r	PROPN
ihlr-18810	205	68	.	.	PROPN
ihlr-18810	205	69	rep	rep	PROPN
ihlr-18810	205	70	.	.	PROPN
ihlr-18810	205	71	no	no	PROPN
ihlr-18810	205	72	.	.	PUNCT
ihlr-18810	206	1	94853	94853	NUM
ihlr-18810	206	2	,	,	PUNCT
ihlr-18810	206	3	at	at	ADP
ihlr-18810	206	4	36	36	NUM
ihlr-18810	206	5	-	-	SYM
ihlr-18810	206	6	37	37	NUM
ihlr-18810	206	7	(	(	PUNCT
ihlr-18810	206	8	1976	1976	NUM
ihlr-18810	206	9	)	)	PUNCT
ihlr-18810	206	10	)	)	PUNCT
ihlr-18810	206	11	.	.	PUNCT
ihlr-18810	207	1	64	64	NUM
ihlr-18810	207	2	21	21	NUM
ihlr-18810	207	3	u.s.c	u.s.c	NOUN
ihlr-18810	207	4	.	.	PUNCT
ihlr-18810	208	1	§	§	PROPN
ihlr-18810	208	2	360c(i)(1)(b	360c(i)(1)(b	PROPN
ihlr-18810	208	3	)	)	PUNCT
ihlr-18810	208	4	(	(	PUNCT
ihlr-18810	208	5	2012	2012	NUM
ihlr-18810	208	6	)	)	PUNCT
ihlr-18810	208	7	(	(	PUNCT
ihlr-18810	208	8	"	"	PUNCT
ihlr-18810	208	9	[	[	X
ihlr-18810	208	10	tlhe	tlhe	NOUN
ihlr-18810	208	11	term	term	NOUN
ihlr-18810	208	12	'	'	PUNCT
ihlr-18810	208	13	different	different	ADJ
ihlr-18810	208	14	technological	technological	ADJ
ihlr-18810	208	15	characteristics	characteristic	NOUN
ihlr-18810	208	16	'	'	PART
ihlr-18810	208	17	means	mean	NOUN
ihlr-18810	208	18	,	,	PUNCT
ihlr-18810	208	19	with	with	ADP
ihlr-18810	208	20	respect	respect	NOUN
ihlr-18810	208	21	to	to	ADP
ihlr-18810	208	22	a	a	DET
ihlr-18810	208	23	device	device	NOUN
ihlr-18810	208	24	being	be	AUX
ihlr-18810	208	25	compared	compare	VERB
ihlr-18810	208	26	to	to	ADP
ihlr-18810	208	27	a	a	DET
ihlr-18810	208	28	predicate	predicate	ADJ
ihlr-18810	208	29	device	device	NOUN
ihlr-18810	208	30	,	,	PUNCT
ihlr-18810	208	31	that	that	SCONJ
ihlr-18810	208	32	there	there	PRON
ihlr-18810	208	33	is	be	VERB
ihlr-18810	208	34	a	a	DET
ihlr-18810	208	35	significant	significant	ADJ
ihlr-18810	208	36	change	change	NOUN
ihlr-18810	208	37	in	in	ADP
ihlr-18810	208	38	the	the	DET
ihlr-18810	208	39	materials	material	NOUN
ihlr-18810	208	40	,	,	PUNCT
ihlr-18810	208	41	design	design	NOUN
ihlr-18810	208	42	,	,	PUNCT
ihlr-18810	208	43	energy	energy	NOUN
ihlr-18810	208	44	source	source	NOUN
ihlr-18810	208	45	,	,	PUNCT
ihlr-18810	208	46	or	or	CCONJ
ihlr-18810	208	47	other	other	ADJ
ihlr-18810	208	48	features	feature	NOUN
ihlr-18810	208	49	of	of	ADP
ihlr-18810	208	50	the	the	DET
ihlr-18810	208	51	device	device	NOUN
ihlr-18810	208	52	from	from	ADP
ihlr-18810	208	53	those	those	PRON
ihlr-18810	208	54	of	of	ADP
ihlr-18810	208	55	the	the	DET
ihlr-18810	208	56	predicate	predicate	NOUN
ihlr-18810	208	57	device	device	NOUN
ihlr-18810	208	58	.	.	PUNCT
ihlr-18810	209	1	"	"	PUNCT
ihlr-18810	209	2	)	)	PUNCT
ihlr-18810	209	3	.	.	PUNCT
ihlr-18810	210	1	vol	vol	NOUN
ihlr-18810	210	2	.	.	PUNCT
ihlr-18810	211	1	10:1128	10:1128	X
ihlr-18810	212	1	510(k	510(k	X
ihlr-18810	212	2	)	)	PUNCT
ihlr-18810	212	3	clearance	clearance	VERB
ihlr-18810	212	4	different	different	ADJ
ihlr-18810	212	5	technological	technological	ADJ
ihlr-18810	212	6	characteristics	characteristic	NOUN
ihlr-18810	212	7	but	but	CCONJ
ihlr-18810	212	8	sufficient	sufficient	ADJ
ihlr-18810	212	9	clinical	clinical	ADJ
ihlr-18810	212	10	data	datum	NOUN
ihlr-18810	212	11	is	be	AUX
ihlr-18810	212	12	provided	provide	VERB
ihlr-18810	212	13	to	to	PART
ihlr-18810	212	14	demonstrate	demonstrate	VERB
ihlr-18810	212	15	it	it	PRON
ihlr-18810	212	16	is	be	AUX
ihlr-18810	212	17	as	as	ADV
ihlr-18810	212	18	safe	safe	ADJ
ihlr-18810	212	19	and	and	CCONJ
ihlr-18810	212	20	effective	effective	ADJ
ihlr-18810	212	21	as	as	ADP
ihlr-18810	212	22	the	the	DET
ihlr-18810	212	23	predicate	predicate	NOUN
ihlr-18810	212	24	device	device	NOUN
ihlr-18810	212	25	.	.	PUNCT
ihlr-18810	213	1	65	65	NUM
ihlr-18810	213	2	the	the	DET
ihlr-18810	213	3	device	device	NOUN
ihlr-18810	213	4	also	also	ADV
ihlr-18810	213	5	can	can	AUX
ihlr-18810	213	6	not	not	PART
ihlr-18810	213	7	raise	raise	VERB
ihlr-18810	213	8	different	different	ADJ
ihlr-18810	213	9	questions	question	NOUN
ihlr-18810	213	10	of	of	ADP
ihlr-18810	213	11	safety	safety	NOUN
ihlr-18810	213	12	and	and	CCONJ
ihlr-18810	213	13	effectiveness	effectiveness	NOUN
ihlr-18810	213	14	than	than	ADP
ihlr-18810	213	15	those	those	PRON
ihlr-18810	213	16	raised	raise	VERB
ihlr-18810	213	17	by	by	ADP
ihlr-18810	213	18	the	the	DET
ihlr-18810	213	19	predicate	predicate	NOUN
ihlr-18810	213	20	device.66	device.66	PROPN
ihlr-18810	213	21	the	the	DET
ihlr-18810	213	22	concept	concept	NOUN
ihlr-18810	213	23	of	of	ADP
ihlr-18810	213	24	substantial	substantial	ADJ
ihlr-18810	213	25	equivalence	equivalence	NOUN
ihlr-18810	213	26	can	can	AUX
ihlr-18810	213	27	be	be	AUX
ihlr-18810	213	28	read	read	VERB
ihlr-18810	213	29	fairly	fairly	ADV
ihlr-18810	213	30	broadly	broadly	ADV
ihlr-18810	213	31	,	,	PUNCT
ihlr-18810	213	32	particularly	particularly	ADV
ihlr-18810	213	33	since	since	SCONJ
ihlr-18810	213	34	the	the	DET
ihlr-18810	213	35	devices	device	NOUN
ihlr-18810	213	36	can	can	AUX
ihlr-18810	213	37	be	be	AUX
ihlr-18810	213	38	compared	compare	VERB
ihlr-18810	213	39	to	to	ADP
ihlr-18810	213	40	a	a	DET
ihlr-18810	213	41	pre-1976	pre-1976	NOUN
ihlr-18810	213	42	device	device	NOUN
ihlr-18810	213	43	or	or	CCONJ
ihlr-18810	213	44	any	any	DET
ihlr-18810	213	45	device	device	NOUN
ihlr-18810	213	46	previously	previously	ADV
ihlr-18810	213	47	cleared	clear	VERB
ihlr-18810	213	48	through	through	ADP
ihlr-18810	213	49	the	the	DET
ihlr-18810	213	50	510(k	510(k	PROPN
ihlr-18810	213	51	)	)	PUNCT
ihlr-18810	213	52	process.67	process.67	NOUN
ihlr-18810	213	53	in	in	ADP
ihlr-18810	213	54	effect	effect	NOUN
ihlr-18810	213	55	,	,	PUNCT
ihlr-18810	213	56	devices	device	NOUN
ihlr-18810	213	57	may	may	AUX
ihlr-18810	213	58	be	be	AUX
ihlr-18810	213	59	cleared	clear	VERB
ihlr-18810	213	60	for	for	ADP
ihlr-18810	213	61	marketing	marketing	NOUN
ihlr-18810	213	62	because	because	SCONJ
ihlr-18810	213	63	of	of	ADP
ihlr-18810	213	64	a	a	DET
ihlr-18810	213	65	finding	finding	NOUN
ihlr-18810	213	66	that	that	SCONJ
ihlr-18810	213	67	they	they	PRON
ihlr-18810	213	68	are	be	AUX
ihlr-18810	213	69	as	as	ADV
ihlr-18810	213	70	safe	safe	ADJ
ihlr-18810	213	71	and	and	CCONJ
ihlr-18810	213	72	effective	effective	ADJ
ihlr-18810	213	73	as	as	ADP
ihlr-18810	213	74	devices	device	NOUN
ihlr-18810	213	75	no	no	ADV
ihlr-18810	213	76	longer	long	ADV
ihlr-18810	213	77	in	in	ADP
ihlr-18810	213	78	use.68	use.68	PROPN
ihlr-18810	213	79	however	however	ADV
ihlr-18810	213	80	,	,	PUNCT
ihlr-18810	213	81	a	a	DET
ihlr-18810	213	82	device	device	NOUN
ihlr-18810	213	83	previously	previously	ADV
ihlr-18810	213	84	removed	remove	VERB
ihlr-18810	213	85	from	from	ADP
ihlr-18810	213	86	the	the	DET
ihlr-18810	213	87	market	market	NOUN
ihlr-18810	213	88	by	by	ADP
ihlr-18810	213	89	the	the	DET
ihlr-18810	213	90	fda	fda	PROPN
ihlr-18810	213	91	or	or	CCONJ
ihlr-18810	213	92	by	by	ADP
ihlr-18810	213	93	a	a	DET
ihlr-18810	213	94	judicial	judicial	ADJ
ihlr-18810	213	95	order	order	NOUN
ihlr-18810	213	96	finding	find	VERB
ihlr-18810	213	97	the	the	DET
ihlr-18810	213	98	device	device	NOUN
ihlr-18810	213	99	misbranded	misbrande	VERB
ihlr-18810	213	100	or	or	CCONJ
ihlr-18810	213	101	adulterated	adulterate	VERB
ihlr-18810	213	102	may	may	AUX
ihlr-18810	213	103	not	not	PART
ihlr-18810	213	104	be	be	AUX
ihlr-18810	213	105	used	use	VERB
ihlr-18810	213	106	as	as	ADP
ihlr-18810	213	107	the	the	DET
ihlr-18810	213	108	predicate	predicate	ADJ
ihlr-18810	213	109	device	device	NOUN
ihlr-18810	213	110	in	in	ADP
ihlr-18810	213	111	a	a	DET
ihlr-18810	213	112	determination	determination	NOUN
ihlr-18810	213	113	of	of	ADP
ihlr-18810	213	114	substantial	substantial	ADJ
ihlr-18810	213	115	equivalence.6	equivalence.6	ADP
ihlr-18810	213	116	9	9	NUM
ihlr-18810	213	117	b.	b.	PROPN
ihlr-18810	213	118	fda	fda	PROPN
ihlr-18810	213	119	regulation	regulation	PROPN
ihlr-18810	213	120	1	1	NUM
ihlr-18810	213	121	.	.	PUNCT
ihlr-18810	214	1	rulemaking	rulemaking	NOUN
ihlr-18810	214	2	and	and	CCONJ
ihlr-18810	214	3	guidance	guidance	VERB
ihlr-18810	214	4	one	one	NUM
ihlr-18810	214	5	important	important	ADJ
ihlr-18810	214	6	way	way	NOUN
ihlr-18810	214	7	the	the	DET
ihlr-18810	214	8	fda	fda	PROPN
ihlr-18810	214	9	increases	increase	VERB
ihlr-18810	214	10	the	the	DET
ihlr-18810	214	11	medical	medical	ADJ
ihlr-18810	214	12	device	device	NOUN
ihlr-18810	214	13	industry	industry	NOUN
ihlr-18810	214	14	's	's	PART
ihlr-18810	214	15	compliance	compliance	NOUN
ihlr-18810	214	16	with	with	ADP
ihlr-18810	214	17	its	its	PRON
ihlr-18810	214	18	regulations	regulation	NOUN
ihlr-18810	214	19	is	be	AUX
ihlr-18810	214	20	through	through	ADP
ihlr-18810	214	21	the	the	DET
ihlr-18810	214	22	issuance	issuance	NOUN
ihlr-18810	214	23	of	of	ADP
ihlr-18810	214	24	rules	rule	NOUN
ihlr-18810	214	25	and	and	CCONJ
ihlr-18810	214	26	guidelines	guideline	NOUN
ihlr-18810	214	27	to	to	PART
ihlr-18810	214	28	clarify	clarify	VERB
ihlr-18810	214	29	expectations	expectation	NOUN
ihlr-18810	214	30	.	.	PUNCT
ihlr-18810	215	1	as	as	SCONJ
ihlr-18810	215	2	industry	industry	NOUN
ihlr-18810	215	3	participants	participant	NOUN
ihlr-18810	215	4	become	become	VERB
ihlr-18810	215	5	better	well	ADV
ihlr-18810	215	6	informed	inform	VERB
ihlr-18810	215	7	and	and	CCONJ
ihlr-18810	215	8	develop	develop	VERB
ihlr-18810	215	9	a	a	DET
ihlr-18810	215	10	greater	great	ADJ
ihlr-18810	215	11	understanding	understanding	NOUN
ihlr-18810	215	12	of	of	ADP
ihlr-18810	215	13	their	their	PRON
ihlr-18810	215	14	obligations	obligation	NOUN
ihlr-18810	215	15	,	,	PUNCT
ihlr-18810	215	16	their	their	PRON
ihlr-18810	215	17	ability	ability	NOUN
ihlr-18810	215	18	to	to	PART
ihlr-18810	215	19	comply	comply	VERB
ihlr-18810	215	20	with	with	ADP
ihlr-18810	215	21	them	they	PRON
ihlr-18810	215	22	is	be	AUX
ihlr-18810	215	23	improved	improve	VERB
ihlr-18810	215	24	;	;	PUNCT
ihlr-18810	215	25	consequently	consequently	ADV
ihlr-18810	215	26	,	,	PUNCT
ihlr-18810	215	27	the	the	DET
ihlr-18810	215	28	need	need	NOUN
ihlr-18810	215	29	for	for	ADP
ihlr-18810	215	30	enforcement	enforcement	NOUN
ihlr-18810	215	31	of	of	ADP
ihlr-18810	215	32	the	the	DET
ihlr-18810	215	33	regulations	regulation	NOUN
ihlr-18810	215	34	decreases	decrease	VERB
ihlr-18810	215	35	.	.	PUNCT
ihlr-18810	216	1	the	the	DET
ihlr-18810	216	2	administrative	administrative	ADJ
ihlr-18810	216	3	procedure	procedure	NOUN
ihlr-18810	216	4	act	act	NOUN
ihlr-18810	216	5	(	(	PUNCT
ihlr-18810	216	6	apa	apa	PROPN
ihlr-18810	216	7	)	)	PUNCT
ihlr-18810	216	8	was	be	AUX
ihlr-18810	216	9	enacted	enact	VERB
ihlr-18810	216	10	in	in	ADP
ihlr-18810	216	11	1946	1946	NUM
ihlr-18810	216	12	to	to	PART
ihlr-18810	216	13	regulate	regulate	VERB
ihlr-18810	216	14	and	and	CCONJ
ihlr-18810	216	15	standard	standard	ADJ
ihlr-18810	216	16	-	-	PUNCT
ihlr-18810	216	17	ize	ize	PROPN
ihlr-18810	216	18	agency	agency	NOUN
ihlr-18810	216	19	actions	action	NOUN
ihlr-18810	216	20	and	and	CCONJ
ihlr-18810	216	21	the	the	DET
ihlr-18810	216	22	65	65	NUM
ihlr-18810	216	23	21	21	NUM
ihlr-18810	216	24	u.s.c	u.s.c	NOUN
ihlr-18810	216	25	.	.	PUNCT
ihlr-18810	217	1	§	§	PROPN
ihlr-18810	217	2	360c(i)(1)(a	360c(i)(1)(a	PROPN
ihlr-18810	217	3	)	)	PUNCT
ihlr-18810	217	4	(	(	PUNCT
ihlr-18810	217	5	2012	2012	NUM
ihlr-18810	217	6	)	)	PUNCT
ihlr-18810	217	7	.	.	PUNCT
ihlr-18810	218	1	66	66	NUM
ihlr-18810	218	2	office	office	NOUN
ihlr-18810	218	3	of	of	ADP
ihlr-18810	218	4	device	device	NOUN
ihlr-18810	218	5	evaluation	evaluation	NOUN
ihlr-18810	218	6	,	,	PUNCT
ihlr-18810	218	7	smda	smda	VERB
ihlr-18810	218	8	changes	change	NOUN
ihlr-18810	218	9	:	:	PUNCT
ihlr-18810	218	10	premarket	premarket	NOUN
ihlr-18810	218	11	notification	notification	NOUN
ihlr-18810	218	12	;	;	PUNCT
ihlr-18810	218	13	regulatory	regulatory	ADJ
ihlr-18810	218	14	requirements	requirement	NOUN
ihlr-18810	218	15	for	for	ADP
ihlr-18810	218	16	medical	medical	ADJ
ihlr-18810	218	17	devices	device	NOUN
ihlr-18810	218	18	(	(	PUNCT
ihlr-18810	218	19	510k	510k	PROPN
ihlr-18810	218	20	)	)	PUNCT
ihlr-18810	218	21	manual	manual	ADJ
ihlr-18810	218	22	insert	insert	NOUN
ihlr-18810	218	23	(	(	PUNCT
ihlr-18810	218	24	1992	1992	NUM
ihlr-18810	218	25	)	)	PUNCT
ihlr-18810	218	26	,	,	PUNCT
ihlr-18810	218	27	available	available	ADJ
ihlr-18810	218	28	at	at	ADP
ihlr-18810	218	29	http://www.fda.gov/	http://www.fda.gov/	PROPN
ihlr-18810	218	30	downloads	download	NOUN
ihlr-18810	218	31	/	/	SYM
ihlr-18810	218	32	medicaldevices	medicaldevice	NOUN
ihlr-18810	218	33	/	/	SYM
ihlr-18810	218	34	deviceregulationandguidance	deviceregulationandguidance	PROPN
ihlr-18810	218	35	/	/	SYM
ihlr-18810	218	36	guidancedoc	guidancedoc	NOUN
ihlr-18810	218	37	uments	ument	NOUN
ihlr-18810	218	38	/	/	SYM
ihlr-18810	218	39	ucmo81355.pdf	ucmo81355.pdf	NOUN
ihlr-18810	218	40	.	.	PUNCT
ihlr-18810	219	1	67	67	NUM
ihlr-18810	220	1	how	how	SCONJ
ihlr-18810	220	2	safe	safe	ADJ
ihlr-18810	220	3	are	be	AUX
ihlr-18810	220	4	medical	medical	ADJ
ihlr-18810	220	5	devices	device	NOUN
ihlr-18810	220	6	.	.	PUNCT
ihlr-18810	221	1	,	,	PUNCT
ihlr-18810	221	2	n.y	n.y	PROPN
ihlr-18810	221	3	.	.	PROPN
ihlr-18810	221	4	times	times	PROPN
ihlr-18810	221	5	,	,	PUNCT
ihlr-18810	221	6	aug	aug	PROPN
ihlr-18810	221	7	.	.	PROPN
ihlr-18810	221	8	4	4	NUM
ihlr-18810	221	9	,	,	PUNCT
ihlr-18810	221	10	2011	2011	NUM
ihlr-18810	221	11	,	,	PUNCT
ihlr-18810	221	12	http://www.nytimes.com/2011/08/05/opinion/how-safe-are-medicaldevices.html?_r=1	http://www.nytimes.com/2011/08/05/opinion/how-safe-are-medicaldevices.html?_r=1	NOUN
ihlr-18810	221	13	(	(	PUNCT
ihlr-18810	221	14	last	last	ADV
ihlr-18810	221	15	visited	visit	VERB
ihlr-18810	221	16	nov	nov	PROPN
ihlr-18810	221	17	.	.	PROPN
ihlr-18810	221	18	26	26	NUM
ihlr-18810	221	19	,	,	PUNCT
ihlr-18810	221	20	2012	2012	NUM
ihlr-18810	221	21	)	)	PUNCT
ihlr-18810	221	22	.	.	PUNCT
ihlr-18810	222	1	68	68	NUM
ihlr-18810	223	1	i	i	PRON
ihlr-18810	223	2	d.	d.	NOUN
ihlr-18810	223	3	69	69	NUM
ihlr-18810	223	4	21	21	NUM
ihlr-18810	223	5	u.s.c	u.s.c	NOUN
ihlr-18810	223	6	.	.	PUNCT
ihlr-18810	224	1	§	§	PROPN
ihlr-18810	224	2	360c(i)(2	360c(i)(2	NUM
ihlr-18810	224	3	)	)	PUNCT
ihlr-18810	224	4	(	(	PUNCT
ihlr-18810	224	5	2012	2012	NUM
ihlr-18810	224	6	)	)	PUNCT
ihlr-18810	224	7	.	.	PUNCT
ihlr-18810	225	1	2013	2013	NUM
ihlr-18810	225	2	129	129	NUM
ihlr-18810	225	3	indiana	indiana	PROPN
ihlr-18810	225	4	health	health	PROPN
ihlr-18810	225	5	law	law	NOUN
ihlr-18810	225	6	review	review	VERB
ihlr-18810	225	7	rulemaking	rulemaking	NOUN
ihlr-18810	225	8	process	process	NOUN
ihlr-18810	225	9	.	.	PUNCT
ihlr-18810	226	1	70	70	NUM
ihlr-18810	226	2	rulemaking	rulemaking	NOUN
ihlr-18810	226	3	refers	refer	VERB
ihlr-18810	226	4	to	to	ADP
ihlr-18810	226	5	the	the	DET
ihlr-18810	226	6	process	process	NOUN
ihlr-18810	226	7	by	by	ADP
ihlr-18810	226	8	which	which	PRON
ihlr-18810	226	9	administrative	administrative	ADJ
ihlr-18810	226	10	agencies	agency	NOUN
ihlr-18810	226	11	,	,	PUNCT
ihlr-18810	226	12	in	in	ADP
ihlr-18810	226	13	following	follow	VERB
ihlr-18810	226	14	broad	broad	ADJ
ihlr-18810	226	15	policy	policy	NOUN
ihlr-18810	226	16	mandates	mandate	NOUN
ihlr-18810	226	17	enacted	enact	VERB
ihlr-18810	226	18	by	by	ADP
ihlr-18810	226	19	the	the	DET
ihlr-18810	226	20	legislature	legislature	NOUN
ihlr-18810	226	21	through	through	ADP
ihlr-18810	226	22	the	the	DET
ihlr-18810	226	23	passage	passage	NOUN
ihlr-18810	226	24	of	of	ADP
ihlr-18810	226	25	statutes	statute	NOUN
ihlr-18810	226	26	,	,	PUNCT
ihlr-18810	226	27	create	create	VERB
ihlr-18810	226	28	regulations	regulation	NOUN
ihlr-18810	226	29	.	.	PUNCT
ihlr-18810	227	1	regulations	regulation	NOUN
ihlr-18810	227	2	refer	refer	VERB
ihlr-18810	227	3	to	to	ADP
ihlr-18810	227	4	rules	rule	NOUN
ihlr-18810	227	5	and/or	and/or	CCONJ
ihlr-18810	227	6	orders	order	NOUN
ihlr-18810	227	7	issued	issue	VERB
ihlr-18810	227	8	by	by	ADP
ihlr-18810	227	9	an	an	DET
ihlr-18810	227	10	agency	agency	NOUN
ihlr-18810	227	11	which	which	PRON
ihlr-18810	227	12	have	have	VERB
ihlr-18810	227	13	the	the	DET
ihlr-18810	227	14	force	force	NOUN
ihlr-18810	227	15	of	of	ADP
ihlr-18810	227	16	law	law	NOUN
ihlr-18810	227	17	;	;	PUNCT
ihlr-18810	227	18	that	that	ADV
ihlr-18810	227	19	is	is	ADV
ihlr-18810	227	20	,	,	PUNCT
ihlr-18810	227	21	which	which	PRON
ihlr-18810	227	22	compel	compel	VERB
ihlr-18810	227	23	action	action	NOUN
ihlr-18810	227	24	by	by	ADP
ihlr-18810	227	25	imposing	impose	VERB
ihlr-18810	227	26	a	a	DET
ihlr-18810	227	27	legal	legal	ADJ
ihlr-18810	227	28	requirement	requirement	NOUN
ihlr-18810	227	29	through	through	ADP
ihlr-18810	227	30	the	the	DET
ihlr-18810	227	31	allocation	allocation	NOUN
ihlr-18810	227	32	of	of	ADP
ihlr-18810	227	33	responsibilities	responsibility	NOUN
ihlr-18810	227	34	or	or	CCONJ
ihlr-18810	227	35	constraint	constraint	NOUN
ihlr-18810	227	36	of	of	ADP
ihlr-18810	227	37	rights.7	rights.7	NOUN
ihlr-18810	227	38	'	'	PUNCT
ihlr-18810	227	39	the	the	DET
ihlr-18810	227	40	apa	apa	PROPN
ihlr-18810	227	41	recognizes	recognize	VERB
ihlr-18810	227	42	only	only	ADV
ihlr-18810	227	43	three	three	NUM
ihlr-18810	227	44	forms	form	NOUN
ihlr-18810	227	45	of	of	ADP
ihlr-18810	227	46	rulemaking	rulemaking	NOUN
ihlr-18810	227	47	:	:	PUNCT
ihlr-18810	227	48	formal	formal	ADJ
ihlr-18810	227	49	(	(	PUNCT
ihlr-18810	227	50	trial	trial	NOUN
ihlr-18810	227	51	-	-	PUNCT
ihlr-18810	227	52	like	like	ADJ
ihlr-18810	227	53	hearing	hearing	NOUN
ihlr-18810	227	54	)	)	PUNCT
ihlr-18810	227	55	,	,	PUNCT
ihlr-18810	227	56	informal	informal	ADJ
ihlr-18810	227	57	(	(	PUNCT
ihlr-18810	227	58	notice	notice	NOUN
ihlr-18810	227	59	and	and	CCONJ
ihlr-18810	227	60	comment	comment	NOUN
ihlr-18810	227	61	)	)	PUNCT
ihlr-18810	227	62	,	,	PUNCT
ihlr-18810	227	63	and	and	CCONJ
ihlr-18810	227	64	negotiated	negotiate	VERB
ihlr-18810	227	65	.	.	PUNCT
ihlr-18810	228	1	72	72	NUM
ihlr-18810	228	2	informal	informal	ADJ
ihlr-18810	228	3	rulemaking	rulemaking	NOUN
ihlr-18810	228	4	is	be	AUX
ihlr-18810	228	5	by	by	ADP
ihlr-18810	228	6	far	far	ADV
ihlr-18810	228	7	the	the	DET
ihlr-18810	228	8	most	most	ADV
ihlr-18810	228	9	common	common	ADJ
ihlr-18810	228	10	,	,	PUNCT
ihlr-18810	228	11	and	and	CCONJ
ihlr-18810	228	12	affords	afford	VERB
ihlr-18810	228	13	the	the	DET
ihlr-18810	228	14	public	public	ADJ
ihlr-18810	228	15	notice	notice	NOUN
ihlr-18810	228	16	of	of	ADP
ihlr-18810	228	17	the	the	DET
ihlr-18810	228	18	proposed	propose	VERB
ihlr-18810	228	19	rule	rule	NOUN
ihlr-18810	228	20	and	and	CCONJ
ihlr-18810	228	21	the	the	DET
ihlr-18810	228	22	opportunity	opportunity	NOUN
ihlr-18810	228	23	to	to	PART
ihlr-18810	228	24	respond	respond	VERB
ihlr-18810	228	25	and	and	CCONJ
ihlr-18810	228	26	comment	comment	VERB
ihlr-18810	228	27	before	before	SCONJ
ihlr-18810	228	28	it	it	PRON
ihlr-18810	228	29	is	be	AUX
ihlr-18810	228	30	enacted	enact	VERB
ihlr-18810	228	31	.	.	PUNCT
ihlr-18810	229	1	73	73	NUM
ihlr-18810	229	2	formal	formal	ADJ
ihlr-18810	229	3	rulemaking	rulemaking	NOUN
ihlr-18810	229	4	is	be	AUX
ihlr-18810	229	5	used	use	VERB
ihlr-18810	229	6	by	by	ADP
ihlr-18810	229	7	agencies	agency	NOUN
ihlr-18810	229	8	only	only	ADV
ihlr-18810	229	9	when	when	SCONJ
ihlr-18810	229	10	a	a	DET
ihlr-18810	229	11	statute	statute	NOUN
ihlr-18810	229	12	requires	require	VERB
ihlr-18810	229	13	it	it	PRON
ihlr-18810	229	14	,	,	PUNCT
ihlr-18810	229	15	and	and	CCONJ
ihlr-18810	229	16	the	the	DET
ihlr-18810	229	17	formal	formal	ADJ
ihlr-18810	229	18	adjudication	adjudication	NOUN
ihlr-18810	229	19	procedures	procedure	NOUN
ihlr-18810	229	20	laid	lay	VERB
ihlr-18810	229	21	out	out	ADP
ihlr-18810	229	22	in	in	ADP
ihlr-18810	229	23	the	the	DET
ihlr-18810	229	24	apa	apa	PROPN
ihlr-18810	229	25	,	,	PUNCT
ihlr-18810	229	26	which	which	PRON
ihlr-18810	229	27	involve	involve	VERB
ihlr-18810	229	28	the	the	DET
ihlr-18810	229	29	submission	submission	NOUN
ihlr-18810	229	30	of	of	ADP
ihlr-18810	229	31	evidence	evidence	NOUN
ihlr-18810	229	32	and	and	CCONJ
ihlr-18810	229	33	the	the	DET
ihlr-18810	229	34	opportunity	opportunity	NOUN
ihlr-18810	229	35	for	for	ADP
ihlr-18810	229	36	crossexamination	crossexamination	NOUN
ihlr-18810	229	37	,	,	PUNCT
ihlr-18810	229	38	must	must	AUX
ihlr-18810	229	39	be	be	AUX
ihlr-18810	229	40	followed	follow	VERB
ihlr-18810	229	41	.	.	PUNCT
ihlr-18810	230	1	74	74	NUM
ihlr-18810	230	2	the	the	DET
ihlr-18810	230	3	fdca	fdca	NOUN
ihlr-18810	230	4	requires	require	VERB
ihlr-18810	230	5	the	the	DET
ihlr-18810	230	6	fda	fda	PROPN
ihlr-18810	230	7	to	to	PART
ihlr-18810	230	8	follow	follow	VERB
ihlr-18810	230	9	formal	formal	ADJ
ihlr-18810	230	10	rulemaking	rulemaking	NOUN
ihlr-18810	230	11	procedures	procedure	NOUN
ihlr-18810	230	12	before	before	ADP
ihlr-18810	230	13	issuing	issue	VERB
ihlr-18810	230	14	a	a	DET
ihlr-18810	230	15	rule.75	rule.75	NOUN
ihlr-18810	230	16	although	although	SCONJ
ihlr-18810	230	17	in	in	ADP
ihlr-18810	230	18	theory	theory	NOUN
ihlr-18810	230	19	these	these	DET
ihlr-18810	230	20	formal	formal	ADJ
ihlr-18810	230	21	procedures	procedure	NOUN
ihlr-18810	230	22	may	may	AUX
ihlr-18810	230	23	provide	provide	VERB
ihlr-18810	230	24	the	the	DET
ihlr-18810	230	25	best	good	ADJ
ihlr-18810	230	26	way	way	NOUN
ihlr-18810	230	27	to	to	PART
ihlr-18810	230	28	ensure	ensure	VERB
ihlr-18810	230	29	affected	affected	ADJ
ihlr-18810	230	30	parties	party	NOUN
ihlr-18810	230	31	are	be	AUX
ihlr-18810	230	32	afforded	afford	VERB
ihlr-18810	230	33	due	due	ADJ
ihlr-18810	230	34	process	process	NOUN
ihlr-18810	230	35	in	in	ADP
ihlr-18810	230	36	the	the	DET
ihlr-18810	230	37	fda	fda	PROPN
ihlr-18810	230	38	's	's	PART
ihlr-18810	230	39	rulemaking	rulemaking	NOUN
ihlr-18810	230	40	process	process	NOUN
ihlr-18810	230	41	,	,	PUNCT
ihlr-18810	230	42	the	the	DET
ihlr-18810	230	43	reality	reality	NOUN
ihlr-18810	230	44	is	be	AUX
ihlr-18810	230	45	that	that	SCONJ
ihlr-18810	230	46	these	these	DET
ihlr-18810	230	47	formal	formal	ADJ
ihlr-18810	230	48	procedures	procedure	NOUN
ihlr-18810	230	49	are	be	AUX
ihlr-18810	230	50	incredibly	incredibly	ADV
ihlr-18810	230	51	time	time	NOUN
ihlr-18810	230	52	consuming	consume	VERB
ihlr-18810	230	53	and	and	CCONJ
ihlr-18810	230	54	inefficient	inefficient	ADJ
ihlr-18810	230	55	.	.	PUNCT
ihlr-18810	231	1	76	76	NUM
ihlr-18810	231	2	consequently	consequently	ADV
ihlr-18810	231	3	courts	court	NOUN
ihlr-18810	231	4	very	very	ADV
ihlr-18810	231	5	rarely	rarely	ADV
ihlr-18810	231	6	compel	compel	VERB
ihlr-18810	231	7	agencies	agency	NOUN
ihlr-18810	231	8	to	to	PART
ihlr-18810	231	9	employ	employ	VERB
ihlr-18810	231	10	these	these	DET
ihlr-18810	231	11	formal	formal	ADJ
ihlr-18810	231	12	measures	measure	NOUN
ihlr-18810	231	13	,	,	PUNCT
ihlr-18810	231	14	instead	instead	ADV
ihlr-18810	231	15	holding	hold	VERB
ihlr-18810	231	16	that	that	SCONJ
ihlr-18810	231	17	the	the	DET
ihlr-18810	231	18	submission	submission	NOUN
ihlr-18810	231	19	of	of	ADP
ihlr-18810	231	20	written	write	VERB
ihlr-18810	231	21	comments	comment	NOUN
ihlr-18810	231	22	by	by	ADP
ihlr-18810	231	23	interested	interested	ADJ
ihlr-18810	231	24	parties	party	NOUN
ihlr-18810	231	25	satisfied	satisfy	VERB
ihlr-18810	231	26	the	the	DET
ihlr-18810	231	27	apa	apa	PROPN
ihlr-18810	231	28	's	's	PART
ihlr-18810	231	29	requirements	requirement	NOUN
ihlr-18810	231	30	for	for	ADP
ihlr-18810	231	31	a	a	DET
ihlr-18810	231	32	proper	proper	ADJ
ihlr-18810	231	33	hearing.77	hearing.77	NOUN
ihlr-18810	231	34	70	70	NUM
ihlr-18810	231	35	kenneth	kenneth	PROPN
ihlr-18810	231	36	f.	f.	PROPN
ihlr-18810	231	37	warren	warren	PROPN
ihlr-18810	231	38	,	,	PUNCT
ihlr-18810	231	39	administrative	administrative	ADJ
ihlr-18810	231	40	law	law	NOUN
ihlr-18810	231	41	in	in	ADP
ihlr-18810	231	42	the	the	DET
ihlr-18810	231	43	political	political	ADJ
ihlr-18810	231	44	system	system	NOUN
ihlr-18810	231	45	215	215	NUM
ihlr-18810	231	46	(	(	PUNCT
ihlr-18810	231	47	2004	2004	NUM
ihlr-18810	231	48	)	)	PUNCT
ihlr-18810	231	49	.	.	PUNCT
ihlr-18810	232	1	71	71	NUM
ihlr-18810	232	2	rulemaking	rulemaking	NOUN
ihlr-18810	232	3	,	,	PUNCT
ihlr-18810	232	4	black	black	NOUN
ihlr-18810	232	5	's	's	PART
ihlr-18810	232	6	law	law	NOUN
ihlr-18810	232	7	dictionary	dictionary	NOUN
ihlr-18810	232	8	(	(	PUNCT
ihlr-18810	232	9	9th	9th	ADJ
ihlr-18810	232	10	ed	ed	NOUN
ihlr-18810	232	11	.	.	PUNCT
ihlr-18810	232	12	2009	2009	NUM
ihlr-18810	232	13	)	)	PUNCT
ihlr-18810	232	14	.	.	PUNCT
ihlr-18810	233	1	72	72	NUM
ihlr-18810	233	2	warren	warren	PROPN
ihlr-18810	233	3	,	,	PUNCT
ihlr-18810	233	4	supra	supra	PROPN
ihlr-18810	233	5	note	note	NOUN
ihlr-18810	233	6	70	70	NUM
ihlr-18810	233	7	,	,	PUNCT
ihlr-18810	233	8	at	at	ADP
ihlr-18810	233	9	218	218	NUM
ihlr-18810	233	10	.	.	PUNCT
ihlr-18810	233	11	73	73	NUM
ihlr-18810	234	1	i	i	PRON
ihlr-18810	234	2	d.	d.	PROPN
ihlr-18810	234	3	74	74	NUM
ihlr-18810	235	1	i	i	PRON
ihlr-18810	235	2	d.	d.	PROPN
ihlr-18810	235	3	75	75	NUM
ihlr-18810	236	1	i	i	PRON
ihlr-18810	236	2	d.	d.	VERB
ihlr-18810	236	3	at	at	ADP
ihlr-18810	236	4	219	219	NUM
ihlr-18810	236	5	-	-	SYM
ihlr-18810	236	6	20	20	NUM
ihlr-18810	236	7	.	.	PUNCT
ihlr-18810	237	1	76	76	NUM
ihlr-18810	238	1	i	i	PRON
ihlr-18810	238	2	d.	d.	NOUN
ihlr-18810	238	3	at	at	ADP
ihlr-18810	238	4	220	220	NUM
ihlr-18810	238	5	(	(	PUNCT
ihlr-18810	238	6	"	"	PUNCT
ihlr-18810	238	7	one	one	NUM
ihlr-18810	238	8	hearing	hearing	NOUN
ihlr-18810	238	9	,	,	PUNCT
ihlr-18810	238	10	which	which	PRON
ihlr-18810	238	11	focused	focus	VERB
ihlr-18810	238	12	on	on	ADP
ihlr-18810	238	13	whether	whether	SCONJ
ihlr-18810	238	14	peanut	peanut	NOUN
ihlr-18810	238	15	butter	butter	NOUN
ihlr-18810	238	16	should	should	AUX
ihlr-18810	238	17	contain	contain	VERB
ihlr-18810	238	18	87.5	87.5	NUM
ihlr-18810	238	19	percent	percent	NOUN
ihlr-18810	238	20	or	or	CCONJ
ihlr-18810	238	21	90	90	NUM
ihlr-18810	238	22	percent	percent	NOUN
ihlr-18810	238	23	peanuts	peanut	NOUN
ihlr-18810	238	24	,	,	PUNCT
ihlr-18810	238	25	produced	produce	VERB
ihlr-18810	238	26	a	a	DET
ihlr-18810	238	27	weighty	weighty	ADJ
ihlr-18810	238	28	7,736	7,736	NUM
ihlr-18810	238	29	-	-	PUNCT
ihlr-18810	238	30	page	page	NOUN
ihlr-18810	238	31	transcript	transcript	NOUN
ihlr-18810	238	32	and	and	CCONJ
ihlr-18810	238	33	lasted	last	VERB
ihlr-18810	238	34	about	about	ADV
ihlr-18810	238	35	nine	nine	NUM
ihlr-18810	238	36	years	year	NOUN
ihlr-18810	238	37	.	.	PUNCT
ihlr-18810	238	38	"	"	PUNCT
ihlr-18810	238	39	)	)	PUNCT
ihlr-18810	238	40	.	.	PUNCT
ihlr-18810	239	1	77	77	NUM
ihlr-18810	240	1	i	i	PRON
ihlr-18810	240	2	d.	d.	PROPN
ihlr-18810	240	3	;	;	PUNCT
ihlr-18810	240	4	united	united	PROPN
ihlr-18810	240	5	states	states	PROPN
ihlr-18810	240	6	v.	v.	PROPN
ihlr-18810	240	7	florida	florida	PROPN
ihlr-18810	240	8	e.	e.	PROPN
ihlr-18810	240	9	coast	coast	PROPN
ihlr-18810	240	10	ry	ry	PROPN
ihlr-18810	240	11	.	.	PROPN
ihlr-18810	240	12	co.	co.	PROPN
ihlr-18810	240	13	,	,	PUNCT
ihlr-18810	240	14	410	410	NUM
ihlr-18810	240	15	u.s	u.s	PROPN
ihlr-18810	240	16	.	.	PROPN
ihlr-18810	240	17	224	224	NUM
ihlr-18810	240	18	,	,	PUNCT
ihlr-18810	240	19	24041	24041	NUM
ihlr-18810	240	20	(	(	PUNCT
ihlr-18810	240	21	1973	1973	NUM
ihlr-18810	240	22	)	)	PUNCT
ihlr-18810	240	23	(	(	PUNCT
ihlr-18810	240	24	"	"	PUNCT
ihlr-18810	240	25	[	[	X
ihlr-18810	240	26	w	w	NOUN
ihlr-18810	240	27	~	~	NOUN
ihlr-18810	240	28	e	e	NOUN
ihlr-18810	240	29	are	be	AUX
ihlr-18810	240	30	convinced	convince	VERB
ihlr-18810	240	31	that	that	SCONJ
ihlr-18810	240	32	the	the	DET
ihlr-18810	240	33	term	term	NOUN
ihlr-18810	240	34	'	'	PUNCT
ihlr-18810	240	35	hearing	hearing	NOUN
ihlr-18810	240	36	'	'	PUNCT
ihlr-18810	240	37	as	as	SCONJ
ihlr-18810	240	38	used	use	VERB
ihlr-18810	240	39	[	[	PUNCT
ihlr-18810	240	40	in	in	ADP
ihlr-18810	240	41	the	the	DET
ihlr-18810	240	42	apa	apa	PROPN
ihlr-18810	240	43	]	]	X
ihlr-18810	240	44	does	do	AUX
ihlr-18810	240	45	not	not	PART
ihlr-18810	240	46	necessarily	necessarily	ADV
ihlr-18810	240	47	embrace	embrace	VERB
ihlr-18810	240	48	either	either	CCONJ
ihlr-18810	240	49	the	the	DET
ihlr-18810	240	50	right	right	NOUN
ihlr-18810	240	51	to	to	PART
ihlr-18810	240	52	present	present	VERB
ihlr-18810	240	53	evidence	evidence	NOUN
ihlr-18810	240	54	130	130	NUM
ihlr-18810	240	55	vol	vol	NOUN
ihlr-18810	240	56	.	.	PUNCT
ihlr-18810	241	1	10:1	10:1	NUM
ihlr-18810	241	2	510(k	510(k	X
ihlr-18810	241	3	)	)	PUNCT
ihlr-18810	241	4	clearance	clearance	NOUN
ihlr-18810	241	5	the	the	DET
ihlr-18810	241	6	fdca	fdca	NOUN
ihlr-18810	241	7	included	include	VERB
ihlr-18810	241	8	in	in	ADP
ihlr-18810	241	9	its	its	PRON
ihlr-18810	241	10	section	section	NOUN
ihlr-18810	241	11	701(a	701(a	NUM
ihlr-18810	241	12	)	)	PUNCT
ihlr-18810	241	13	a	a	DET
ihlr-18810	241	14	general	general	ADJ
ihlr-18810	241	15	rulemaking	rulemaking	NOUN
ihlr-18810	241	16	grant	grant	NOUN
ihlr-18810	241	17	for	for	ADP
ihlr-18810	241	18	the	the	DET
ihlr-18810	241	19	fda	fda	PROPN
ihlr-18810	241	20	to	to	PART
ihlr-18810	241	21	issue	issue	VERB
ihlr-18810	241	22	guidance	guidance	NOUN
ihlr-18810	241	23	,	,	PUNCT
ihlr-18810	241	24	but	but	CCONJ
ihlr-18810	241	25	this	this	DET
ihlr-18810	241	26	grant	grant	NOUN
ihlr-18810	241	27	did	do	AUX
ihlr-18810	241	28	not	not	PART
ihlr-18810	241	29	confer	confer	VERB
ihlr-18810	241	30	overarching	overarching	ADJ
ihlr-18810	241	31	legislative	legislative	ADJ
ihlr-18810	241	32	rulemaking	rulemaking	NOUN
ihlr-18810	241	33	authority.78	authority.78	PROPN
ihlr-18810	241	34	section	section	NOUN
ihlr-18810	241	35	701	701	NUM
ihlr-18810	241	36	set	set	VERB
ihlr-18810	241	37	forth	forth	ADP
ihlr-18810	241	38	detailed	detailed	ADJ
ihlr-18810	241	39	procedures	procedure	NOUN
ihlr-18810	241	40	for	for	ADP
ihlr-18810	241	41	public	public	ADJ
ihlr-18810	241	42	hearings	hearing	NOUN
ihlr-18810	241	43	and	and	CCONJ
ihlr-18810	241	44	judicial	judicial	ADJ
ihlr-18810	241	45	review	review	NOUN
ihlr-18810	241	46	to	to	PART
ihlr-18810	241	47	be	be	AUX
ihlr-18810	241	48	followed	follow	VERB
ihlr-18810	241	49	in	in	ADP
ihlr-18810	241	50	the	the	DET
ihlr-18810	241	51	promulgation	promulgation	NOUN
ihlr-18810	241	52	of	of	ADP
ihlr-18810	241	53	rules	rule	NOUN
ihlr-18810	241	54	(	(	PUNCT
ihlr-18810	241	55	formal	formal	ADJ
ihlr-18810	241	56	rulemaking	rulemaking	NOUN
ihlr-18810	241	57	procedures	procedure	NOUN
ihlr-18810	241	58	)	)	PUNCT
ihlr-18810	241	59	,	,	PUNCT
ihlr-18810	241	60	and	and	CCONJ
ihlr-18810	241	61	section	section	NOUN
ihlr-18810	241	62	701(a	701(a	PROPN
ihlr-18810	241	63	)	)	PUNCT
ihlr-18810	241	64	granted	grant	VERB
ihlr-18810	241	65	a	a	DET
ihlr-18810	241	66	general	general	ADJ
ihlr-18810	241	67	rulemaking	rulemake	VERB
ihlr-18810	241	68	power	power	NOUN
ihlr-18810	241	69	to	to	PART
ihlr-18810	241	70	promulgate	promulgate	VERB
ihlr-18810	241	71	rules	rule	NOUN
ihlr-18810	241	72	in	in	ADP
ihlr-18810	241	73	the	the	DET
ihlr-18810	241	74	enforcement	enforcement	NOUN
ihlr-18810	241	75	of	of	ADP
ihlr-18810	241	76	the	the	DET
ihlr-18810	241	77	fdca.79	fdca.79	NOUN
ihlr-18810	241	78	rules	rule	NOUN
ihlr-18810	241	79	promulgated	promulgate	VERB
ihlr-18810	241	80	under	under	ADP
ihlr-18810	241	81	the	the	DET
ihlr-18810	241	82	authority	authority	NOUN
ihlr-18810	241	83	granted	grant	VERB
ihlr-18810	241	84	under	under	ADP
ihlr-18810	241	85	section	section	NOUN
ihlr-18810	241	86	701(a	701(a	PROPN
ihlr-18810	241	87	)	)	PUNCT
ihlr-18810	241	88	,	,	PUNCT
ihlr-18810	241	89	however	however	ADV
ihlr-18810	241	90	,	,	PUNCT
ihlr-18810	241	91	were	be	AUX
ihlr-18810	241	92	not	not	PART
ihlr-18810	241	93	granted	grant	VERB
ihlr-18810	241	94	the	the	DET
ihlr-18810	241	95	force	force	NOUN
ihlr-18810	241	96	of	of	ADP
ihlr-18810	241	97	law	law	NOUN
ihlr-18810	241	98	because	because	SCONJ
ihlr-18810	241	99	a	a	DET
ihlr-18810	241	100	violator	violator	NOUN
ihlr-18810	241	101	of	of	ADP
ihlr-18810	241	102	any	any	DET
ihlr-18810	241	103	regulations	regulation	NOUN
ihlr-18810	241	104	promulgated	promulgate	VERB
ihlr-18810	241	105	thereunder	thereunder	NOUN
ihlr-18810	241	106	would	would	AUX
ihlr-18810	241	107	not	not	PART
ihlr-18810	241	108	be	be	AUX
ihlr-18810	241	109	subject	subject	ADJ
ihlr-18810	241	110	to	to	ADP
ihlr-18810	241	111	any	any	DET
ihlr-18810	241	112	sanctions	sanction	NOUN
ihlr-18810	241	113	,	,	PUNCT
ihlr-18810	241	114	penalties	penalty	NOUN
ihlr-18810	241	115	,	,	PUNCT
ihlr-18810	241	116	or	or	CCONJ
ihlr-18810	241	117	other	other	ADJ
ihlr-18810	241	118	legal	legal	ADJ
ihlr-18810	241	119	consequences.8	consequences.8	PROPN
ihlr-18810	241	120	0	0	NUM
ihlr-18810	241	121	in	in	ADP
ihlr-18810	241	122	contrast	contrast	NOUN
ihlr-18810	241	123	,	,	PUNCT
ihlr-18810	241	124	there	there	PRON
ihlr-18810	241	125	were	be	VERB
ihlr-18810	241	126	several	several	ADJ
ihlr-18810	241	127	specific	specific	ADJ
ihlr-18810	241	128	rulemaking	rulemaking	NOUN
ihlr-18810	241	129	grants	grant	NOUN
ihlr-18810	241	130	throughout	throughout	ADP
ihlr-18810	241	131	the	the	DET
ihlr-18810	241	132	fdca	fdca	NOUN
ihlr-18810	241	133	which	which	PRON
ihlr-18810	241	134	authorized	authorize	VERB
ihlr-18810	241	135	rulemaking	rulemaking	NOUN
ihlr-18810	241	136	with	with	ADP
ihlr-18810	241	137	the	the	DET
ihlr-18810	241	138	force	force	NOUN
ihlr-18810	241	139	of	of	ADP
ihlr-18810	241	140	law	law	NOUN
ihlr-18810	241	141	over	over	ADP
ihlr-18810	241	142	specific	specific	ADJ
ihlr-18810	241	143	issues	issue	NOUN
ihlr-18810	241	144	;	;	PUNCT
ihlr-18810	241	145	for	for	ADP
ihlr-18810	241	146	example	example	NOUN
ihlr-18810	241	147	,	,	PUNCT
ihlr-18810	241	148	misbranding	misbranding	NOUN
ihlr-18810	241	149	and	and	CCONJ
ihlr-18810	241	150	the	the	DET
ihlr-18810	241	151	use	use	NOUN
ihlr-18810	241	152	of	of	ADP
ihlr-18810	241	153	marks	mark	NOUN
ihlr-18810	241	154	,	,	PUNCT
ihlr-18810	241	155	stamps	stamp	NOUN
ihlr-18810	241	156	,	,	PUNCT
ihlr-18810	241	157	tags	tag	NOUN
ihlr-18810	241	158	,	,	PUNCT
ihlr-18810	241	159	or	or	CCONJ
ihlr-18810	241	160	labels	label	NOUN
ihlr-18810	241	161	in	in	ADP
ihlr-18810	241	162	foods.8	foods.8	PROPN
ihlr-18810	241	163	'	'	PUNCT
ihlr-18810	241	164	these	these	DET
ihlr-18810	241	165	regulations	regulation	NOUN
ihlr-18810	241	166	were	be	AUX
ihlr-18810	241	167	given	give	VERB
ihlr-18810	241	168	legislative	legislative	ADJ
ihlr-18810	241	169	effect	effect	NOUN
ihlr-18810	241	170	by	by	ADP
ihlr-18810	241	171	sections	section	NOUN
ihlr-18810	241	172	of	of	ADP
ihlr-18810	241	173	the	the	DET
ihlr-18810	241	174	fdca	fdca	NOUN
ihlr-18810	241	175	which	which	PRON
ihlr-18810	241	176	expressly	expressly	ADV
ihlr-18810	241	177	made	make	VERB
ihlr-18810	241	178	their	their	PRON
ihlr-18810	241	179	violation	violation	NOUN
ihlr-18810	241	180	unlawful	unlawful	ADJ
ihlr-18810	241	181	and	and	CCONJ
ihlr-18810	241	182	subject	subject	ADJ
ihlr-18810	241	183	to	to	ADP
ihlr-18810	241	184	penalties	penalty	NOUN
ihlr-18810	241	185	.	.	PUNCT
ihlr-18810	242	1	82	82	NUM
ihlr-18810	242	2	in	in	ADP
ihlr-18810	242	3	the	the	DET
ihlr-18810	242	4	1960s	1960	NOUN
ihlr-18810	242	5	and	and	CCONJ
ihlr-18810	242	6	70s	70	NOUN
ihlr-18810	242	7	the	the	DET
ihlr-18810	242	8	fda	fda	PROPN
ihlr-18810	242	9	began	begin	VERB
ihlr-18810	242	10	to	to	PART
ihlr-18810	242	11	assert	assert	VERB
ihlr-18810	242	12	a	a	DET
ihlr-18810	242	13	right	right	NOUN
ihlr-18810	242	14	to	to	PART
ihlr-18810	242	15	issue	issue	VERB
ihlr-18810	242	16	legislative	legislative	ADJ
ihlr-18810	242	17	rules	rule	NOUN
ihlr-18810	242	18	using	use	VERB
ihlr-18810	242	19	informal	informal	ADJ
ihlr-18810	242	20	notice	notice	NOUN
ihlr-18810	242	21	-	-	PUNCT
ihlr-18810	242	22	and	and	CCONJ
ihlr-18810	242	23	-	-	PUNCT
ihlr-18810	242	24	comment	comment	NOUN
ihlr-18810	242	25	procedures	procedure	NOUN
ihlr-18810	242	26	.	.	PUNCT
ihlr-18810	243	1	83	83	NUM
ihlr-18810	243	2	to	to	PART
ihlr-18810	243	3	do	do	VERB
ihlr-18810	243	4	this	this	PRON
ihlr-18810	243	5	,	,	PUNCT
ihlr-18810	243	6	the	the	DET
ihlr-18810	243	7	fda	fda	PROPN
ihlr-18810	243	8	's	's	PART
ihlr-18810	243	9	chief	chief	ADJ
ihlr-18810	243	10	counsel	counsel	NOUN
ihlr-18810	243	11	peter	peter	PROPN
ihlr-18810	243	12	barton	barton	PROPN
ihlr-18810	243	13	hutt	hutt	PROPN
ihlr-18810	243	14	asserted	assert	VERB
ihlr-18810	243	15	that	that	SCONJ
ihlr-18810	243	16	the	the	DET
ihlr-18810	243	17	fdca	fdca	NOUN
ihlr-18810	243	18	should	should	AUX
ihlr-18810	243	19	be	be	AUX
ihlr-18810	243	20	viewed	view	VERB
ihlr-18810	243	21	as	as	ADP
ihlr-18810	243	22	laying	lay	VERB
ihlr-18810	243	23	out	out	ADP
ihlr-18810	243	24	a	a	DET
ihlr-18810	243	25	set	set	NOUN
ihlr-18810	243	26	of	of	ADP
ihlr-18810	243	27	fundamental	fundamental	ADJ
ihlr-18810	243	28	objectives	objective	NOUN
ihlr-18810	243	29	for	for	ADP
ihlr-18810	243	30	the	the	DET
ihlr-18810	243	31	agency	agency	NOUN
ihlr-18810	243	32	and	and	CCONJ
ihlr-18810	243	33	the	the	DET
ihlr-18810	243	34	broad	broad	ADJ
ihlr-18810	243	35	authority	authority	NOUN
ihlr-18810	243	36	to	to	PART
ihlr-18810	243	37	implement	implement	VERB
ihlr-18810	243	38	these	these	DET
ihlr-18810	243	39	objectives	objective	NOUN
ihlr-18810	243	40	through	through	ADP
ihlr-18810	243	41	a	a	DET
ihlr-18810	243	42	power	power	NOUN
ihlr-18810	243	43	to	to	PART
ihlr-18810	243	44	do	do	AUX
ihlr-18810	243	45	anything	anything	PRON
ihlr-18810	243	46	not	not	PART
ihlr-18810	243	47	specifically	specifically	ADV
ihlr-18810	243	48	made	make	VERB
ihlr-18810	243	49	an	an	DET
ihlr-18810	243	50	exception	exception	NOUN
ihlr-18810	243	51	or	or	CCONJ
ihlr-18810	243	52	withheld	withhold	VERB
ihlr-18810	243	53	by	by	ADP
ihlr-18810	243	54	the	the	DET
ihlr-18810	243	55	fdca.84	fdca.84	NOUN
ihlr-18810	243	56	orally	orally	ADV
ihlr-18810	243	57	and	and	CCONJ
ihlr-18810	243	58	to	to	ADP
ihlr-18810	243	59	cross	cross	VERB
ihlr-18810	243	60	-	-	ADJ
ihlr-18810	243	61	examine	examine	ADJ
ihlr-18810	243	62	opposing	opposing	ADJ
ihlr-18810	243	63	witnesses	witness	NOUN
ihlr-18810	243	64	,	,	PUNCT
ihlr-18810	243	65	or	or	CCONJ
ihlr-18810	243	66	the	the	DET
ihlr-18810	243	67	right	right	NOUN
ihlr-18810	243	68	to	to	PART
ihlr-18810	243	69	present	present	VERB
ihlr-18810	243	70	oral	oral	ADJ
ihlr-18810	243	71	argument	argument	NOUN
ihlr-18810	243	72	to	to	ADP
ihlr-18810	243	73	the	the	DET
ihlr-18810	243	74	agency	agency	NOUN
ihlr-18810	243	75	's	's	PART
ihlr-18810	243	76	decisionmaker	decisionmaker	NOUN
ihlr-18810	243	77	.	.	PUNCT
ihlr-18810	243	78	.	.	PUNCT
ihlr-18810	243	79	.	.	PUNCT
ihlr-18810	243	80	.	.	PUNCT
ihlr-18810	244	1	[	[	X
ihlr-18810	244	2	tihe	tihe	X
ihlr-18810	244	3	[	[	X
ihlr-18810	244	4	apa	apa	X
ihlr-18810	244	5	]	]	X
ihlr-18810	244	6	makes	make	VERB
ihlr-18810	244	7	it	it	PRON
ihlr-18810	244	8	plain	plain	ADJ
ihlr-18810	244	9	that	that	SCONJ
ihlr-18810	244	10	a	a	DET
ihlr-18810	244	11	specific	specific	ADJ
ihlr-18810	244	12	statutory	statutory	ADJ
ihlr-18810	244	13	mandate	mandate	NOUN
ihlr-18810	244	14	that	that	SCONJ
ihlr-18810	244	15	the	the	DET
ihlr-18810	244	16	proceedings	proceeding	NOUN
ihlr-18810	244	17	take	take	VERB
ihlr-18810	244	18	place	place	NOUN
ihlr-18810	244	19	on	on	ADP
ihlr-18810	244	20	the	the	DET
ihlr-18810	244	21	record	record	NOUN
ihlr-18810	244	22	after	after	ADP
ihlr-18810	244	23	hearing	hearing	NOUN
ihlr-18810	244	24	may	may	AUX
ihlr-18810	244	25	be	be	AUX
ihlr-18810	244	26	satisfied	satisfied	ADJ
ihlr-18810	244	27	in	in	ADP
ihlr-18810	244	28	some	some	DET
ihlr-18810	244	29	circumstances	circumstance	NOUN
ihlr-18810	244	30	by	by	ADP
ihlr-18810	244	31	evidentiary	evidentiary	ADJ
ihlr-18810	244	32	submission	submission	NOUN
ihlr-18810	244	33	in	in	ADP
ihlr-18810	244	34	written	write	VERB
ihlr-18810	244	35	form	form	NOUN
ihlr-18810	244	36	only	only	ADV
ihlr-18810	244	37	.	.	PUNCT
ihlr-18810	244	38	"	"	PUNCT
ihlr-18810	244	39	)	)	PUNCT
ihlr-18810	244	40	.	.	PUNCT
ihlr-18810	245	1	78	78	NUM
ihlr-18810	245	2	thomas	thomas	PROPN
ihlr-18810	245	3	w.	w.	PROPN
ihlr-18810	245	4	merrill	merrill	PROPN
ihlr-18810	245	5	&	&	CCONJ
ihlr-18810	245	6	kathryn	kathryn	PROPN
ihlr-18810	245	7	tongue	tongue	PROPN
ihlr-18810	245	8	watts	watts	PROPN
ihlr-18810	245	9	,	,	PUNCT
ihlr-18810	245	10	agency	agency	NOUN
ihlr-18810	245	11	rules	rule	NOUN
ihlr-18810	245	12	with	with	ADP
ihlr-18810	245	13	the	the	DET
ihlr-18810	245	14	force	force	NOUN
ihlr-18810	245	15	of	of	ADP
ihlr-18810	245	16	la	la	PROPN
ihlr-18810	245	17	w	w	PROPN
ihlr-18810	245	18	:	:	PUNCT
ihlr-18810	245	19	the	the	DET
ihlr-18810	245	20	original	original	ADJ
ihlr-18810	245	21	convention	convention	NOUN
ihlr-18810	245	22	,	,	PUNCT
ihlr-18810	245	23	116	116	NUM
ihlr-18810	245	24	harv	harv	NOUN
ihlr-18810	245	25	.	.	PUNCT
ihlr-18810	246	1	l.	l.	PROPN
ihlr-18810	246	2	rev	rev	PROPN
ihlr-18810	246	3	.	.	PROPN
ihlr-18810	246	4	467	467	NUM
ihlr-18810	246	5	,	,	PUNCT
ihlr-18810	246	6	557	557	NUM
ihlr-18810	246	7	(	(	PUNCT
ihlr-18810	246	8	2002	2002	NUM
ihlr-18810	246	9	)	)	PUNCT
ihlr-18810	246	10	.	.	PUNCT
ihlr-18810	247	1	79	79	NUM
ihlr-18810	248	1	i	i	PRON
ihlr-18810	248	2	d.	d.	NOUN
ihlr-18810	248	3	at	at	ADP
ihlr-18810	248	4	514	514	NUM
ihlr-18810	248	5	.	.	PUNCT
ihlr-18810	248	6	80	80	NUM
ihlr-18810	249	1	i	i	PRON
ihlr-18810	249	2	d.	d.	NOUN
ihlr-18810	249	3	at	at	ADP
ihlr-18810	249	4	515	515	NUM
ihlr-18810	249	5	.	.	PUNCT
ihlr-18810	249	6	81	81	NUM
ihlr-18810	250	1	i	i	PRON
ihlr-18810	250	2	d.	d.	PROPN
ihlr-18810	250	3	at	at	ADP
ihlr-18810	250	4	514	514	NUM
ihlr-18810	250	5	n.	n.	NOUN
ihlr-18810	250	6	244	244	NUM
ihlr-18810	250	7	.	.	PUNCT
ihlr-18810	251	1	82	82	NUM
ihlr-18810	252	1	i	i	PRON
ihlr-18810	252	2	d.	d.	PROPN
ihlr-18810	252	3	at	at	ADP
ihlr-18810	252	4	514	514	NUM
ihlr-18810	252	5	.	.	PUNCT
ihlr-18810	252	6	83	83	NUM
ihlr-18810	253	1	i	i	PRON
ihlr-18810	253	2	d.	d.	PROPN
ihlr-18810	253	3	at	at	ADP
ihlr-18810	253	4	558	558	NUM
ihlr-18810	253	5	.	.	PUNCT
ihlr-18810	254	1	84	84	NUM
ihlr-18810	255	1	i	i	PRON
ihlr-18810	255	2	d.	d.	PROPN
ihlr-18810	255	3	2013	2013	NUM
ihlr-18810	255	4	131	131	NUM
ihlr-18810	255	5	indiana	indiana	PROPN
ihlr-18810	255	6	health	health	PROPN
ihlr-18810	255	7	law	law	PROPN
ihlr-18810	255	8	review	review	VERB
ihlr-18810	255	9	this	this	DET
ihlr-18810	255	10	theory	theory	NOUN
ihlr-18810	255	11	eventually	eventually	ADV
ihlr-18810	255	12	made	make	VERB
ihlr-18810	255	13	it	it	PRON
ihlr-18810	255	14	to	to	ADP
ihlr-18810	255	15	the	the	DET
ihlr-18810	255	16	supreme	supreme	PROPN
ihlr-18810	255	17	court	court	PROPN
ihlr-18810	255	18	when	when	SCONJ
ihlr-18810	255	19	regulations	regulation	NOUN
ihlr-18810	255	20	issued	issue	VERB
ihlr-18810	255	21	by	by	ADP
ihlr-18810	255	22	the	the	DET
ihlr-18810	255	23	fda	fda	PROPN
ihlr-18810	255	24	under	under	ADP
ihlr-18810	255	25	701(a	701(a	PROPN
ihlr-18810	255	26	)	)	PUNCT
ihlr-18810	255	27	authority	authority	NOUN
ihlr-18810	255	28	were	be	AUX
ihlr-18810	255	29	challenged	challenge	VERB
ihlr-18810	255	30	.	.	PUNCT
ihlr-18810	256	1	85	85	NUM
ihlr-18810	256	2	the	the	DET
ihlr-18810	256	3	court	court	NOUN
ihlr-18810	256	4	assumed	assume	VERB
ihlr-18810	256	5	without	without	ADP
ihlr-18810	256	6	discussion	discussion	NOUN
ihlr-18810	256	7	that	that	SCONJ
ihlr-18810	256	8	the	the	DET
ihlr-18810	256	9	fda	fda	PROPN
ihlr-18810	256	10	indeed	indeed	ADV
ihlr-18810	256	11	had	have	VERB
ihlr-18810	256	12	the	the	DET
ihlr-18810	256	13	authority	authority	NOUN
ihlr-18810	256	14	to	to	PART
ihlr-18810	256	15	issue	issue	VERB
ihlr-18810	256	16	the	the	DET
ihlr-18810	256	17	regulations.86	regulations.86	ADJ
ihlr-18810	256	18	later	later	ADV
ihlr-18810	256	19	,	,	PUNCT
ihlr-18810	256	20	the	the	DET
ihlr-18810	256	21	second	second	ADJ
ihlr-18810	256	22	circuit	circuit	NOUN
ihlr-18810	256	23	in	in	ADP
ihlr-18810	256	24	national	national	ADJ
ihlr-18810	256	25	nutritional	nutritional	ADJ
ihlr-18810	256	26	foods	food	NOUN
ihlr-18810	256	27	association	association	PROPN
ihlr-18810	256	28	v.	v.	ADP
ihlr-18810	256	29	weinberger	weinberger	PROPN
ihlr-18810	256	30	expressly	expressly	ADV
ihlr-18810	256	31	held	hold	VERB
ihlr-18810	256	32	the	the	DET
ihlr-18810	256	33	fda	fda	PROPN
ihlr-18810	256	34	has	have	VERB
ihlr-18810	256	35	such	such	ADJ
ihlr-18810	256	36	general	general	ADJ
ihlr-18810	256	37	rulemaking	rulemaking	NOUN
ihlr-18810	256	38	authority	authority	NOUN
ihlr-18810	256	39	.	.	PUNCT
ihlr-18810	257	1	the	the	DET
ihlr-18810	257	2	court	court	NOUN
ihlr-18810	257	3	explained	explain	VERB
ihlr-18810	257	4	:	:	PUNCT
ihlr-18810	257	5	congress	congress	PROPN
ihlr-18810	257	6	'	'	PART
ihlr-18810	257	7	establishment	establishment	NOUN
ihlr-18810	257	8	of	of	ADP
ihlr-18810	257	9	a	a	DET
ihlr-18810	257	10	specific	specific	ADJ
ihlr-18810	257	11	(	(	PUNCT
ihlr-18810	257	12	and	and	CCONJ
ihlr-18810	257	13	elaborate	elaborate	ADJ
ihlr-18810	257	14	)	)	PUNCT
ihlr-18810	257	15	procedure	procedure	NOUN
ihlr-18810	257	16	in	in	ADP
ihlr-18810	257	17	[	[	X
ihlr-18810	257	18	i§	i§	PROPN
ihlr-18810	257	19	701(e	701(e	NOUN
ihlr-18810	257	20	)	)	PUNCT
ihlr-18810	257	21	authorizing	authorize	VERB
ihlr-18810	257	22	the	the	DET
ihlr-18810	257	23	fda	fda	PROPN
ihlr-18810	257	24	to	to	PART
ihlr-18810	257	25	promulgate	promulgate	VERB
ihlr-18810	257	26	regulations	regulation	NOUN
ihlr-18810	257	27	in	in	ADP
ihlr-18810	257	28	certain	certain	ADJ
ihlr-18810	257	29	fields	field	NOUN
ihlr-18810	257	30	was	be	AUX
ihlr-18810	257	31	in	in	ADP
ihlr-18810	257	32	addition	addition	NOUN
ihlr-18810	257	33	to	to	ADP
ihlr-18810	257	34	and	and	CCONJ
ihlr-18810	257	35	not	not	PART
ihlr-18810	257	36	in	in	ADP
ihlr-18810	257	37	derogation	derogation	NOUN
ihlr-18810	257	38	of	of	ADP
ihlr-18810	257	39	the	the	DET
ihlr-18810	257	40	general	general	ADJ
ihlr-18810	257	41	rule	rule	NOUN
ihlr-18810	257	42	-	-	PUNCT
ihlr-18810	257	43	making	make	VERB
ihlr-18810	257	44	power	power	NOUN
ihlr-18810	257	45	granted	grant	VERB
ihlr-18810	257	46	to	to	ADP
ihlr-18810	257	47	the	the	DET
ihlr-18810	257	48	fda	fda	PROPN
ihlr-18810	257	49	by	by	ADP
ihlr-18810	257	50	§	§	PROPN
ihlr-18810	257	51	701(a	701(a	PROPN
ihlr-18810	257	52	)	)	PUNCT
ihlr-18810	257	53	.	.	PUNCT
ihlr-18810	258	1	under	under	ADP
ihlr-18810	258	2	the	the	DET
ihlr-18810	258	3	latter	latter	ADJ
ihlr-18810	258	4	section	section	NOUN
ihlr-18810	258	5	,	,	PUNCT
ihlr-18810	258	6	furthermore	furthermore	ADV
ihlr-18810	258	7	,	,	PUNCT
ihlr-18810	258	8	the	the	DET
ihlr-18810	258	9	fda	fda	PROPN
ihlr-18810	258	10	may	may	AUX
ihlr-18810	258	11	follow	follow	VERB
ihlr-18810	258	12	streamlined	streamlined	ADJ
ihlr-18810	258	13	procedures	procedure	NOUN
ihlr-18810	258	14	designed	design	VERB
ihlr-18810	258	15	to	to	PART
ihlr-18810	258	16	avoid	avoid	VERB
ihlr-18810	258	17	the	the	DET
ihlr-18810	258	18	endless	endless	ADJ
ihlr-18810	258	19	delays	delay	NOUN
ihlr-18810	258	20	that	that	PRON
ihlr-18810	258	21	have	have	AUX
ihlr-18810	258	22	tended	tend	VERB
ihlr-18810	258	23	to	to	PART
ihlr-18810	258	24	paralyze	paralyze	VERB
ihlr-18810	258	25	adjudicatory	adjudicatory	ADJ
ihlr-18810	258	26	hearings	hearing	NOUN
ihlr-18810	258	27	and	and	CCONJ
ihlr-18810	258	28	render	render	VERB
ihlr-18810	258	29	them	they	PRON
ihlr-18810	258	30	ineffective	ineffective	ADJ
ihlr-18810	258	31	as	as	ADP
ihlr-18810	258	32	a	a	DET
ihlr-18810	258	33	means	means	NOUN
ihlr-18810	258	34	of	of	ADP
ihlr-18810	258	35	utilizing	utilize	VERB
ihlr-18810	258	36	agency	agency	NOUN
ihlr-18810	258	37	expertise.87	expertise.87	NOUN
ihlr-18810	258	38	although	although	SCONJ
ihlr-18810	258	39	recognized	recognize	VERB
ihlr-18810	258	40	by	by	ADP
ihlr-18810	258	41	the	the	DET
ihlr-18810	258	42	courts	court	NOUN
ihlr-18810	258	43	as	as	ADP
ihlr-18810	258	44	an	an	DET
ihlr-18810	258	45	efficient	efficient	ADJ
ihlr-18810	258	46	way	way	NOUN
ihlr-18810	258	47	for	for	SCONJ
ihlr-18810	258	48	the	the	DET
ihlr-18810	258	49	fda	fda	PROPN
ihlr-18810	258	50	to	to	PART
ihlr-18810	258	51	avoid	avoid	VERB
ihlr-18810	258	52	the	the	DET
ihlr-18810	258	53	cumbersome	cumbersome	ADJ
ihlr-18810	258	54	hearings	hearing	NOUN
ihlr-18810	258	55	required	require	VERB
ihlr-18810	258	56	of	of	ADP
ihlr-18810	258	57	formal	formal	ADJ
ihlr-18810	258	58	rulemaking	rulemaking	NOUN
ihlr-18810	258	59	in	in	ADP
ihlr-18810	258	60	the	the	DET
ihlr-18810	258	61	exercise	exercise	NOUN
ihlr-18810	258	62	of	of	ADP
ihlr-18810	258	63	its	its	PRON
ihlr-18810	258	64	authority	authority	NOUN
ihlr-18810	258	65	,	,	PUNCT
ihlr-18810	258	66	informal	informal	ADJ
ihlr-18810	258	67	rulemaking	rulemaking	NOUN
ihlr-18810	258	68	does	do	AUX
ihlr-18810	258	69	present	present	VERB
ihlr-18810	258	70	problems	problem	NOUN
ihlr-18810	258	71	of	of	ADP
ihlr-18810	258	72	its	its	PRON
ihlr-18810	258	73	own	own	ADJ
ihlr-18810	258	74	for	for	ADP
ihlr-18810	258	75	the	the	DET
ihlr-18810	258	76	fda	fda	PROPN
ihlr-18810	258	77	.	.	PUNCT
ihlr-18810	259	1	all	all	DET
ihlr-18810	259	2	branches	branch	NOUN
ihlr-18810	259	3	of	of	ADP
ihlr-18810	259	4	government	government	NOUN
ihlr-18810	259	5	have	have	AUX
ihlr-18810	259	6	imposed	impose	VERB
ihlr-18810	259	7	additional	additional	ADJ
ihlr-18810	259	8	procedural	procedural	ADJ
ihlr-18810	259	9	demands	demand	NOUN
ihlr-18810	259	10	on	on	ADP
ihlr-18810	259	11	the	the	DET
ihlr-18810	259	12	informal	informal	ADJ
ihlr-18810	259	13	process	process	NOUN
ihlr-18810	259	14	,	,	PUNCT
ihlr-18810	259	15	making	make	VERB
ihlr-18810	259	16	it	it	PRON
ihlr-18810	259	17	increasingly	increasingly	ADV
ihlr-18810	259	18	more	more	ADV
ihlr-18810	259	19	difficult	difficult	ADJ
ihlr-18810	259	20	to	to	PART
ihlr-18810	259	21	issue	issue	VERB
ihlr-18810	259	22	rules	rule	NOUN
ihlr-18810	259	23	in	in	ADP
ihlr-18810	259	24	this	this	DET
ihlr-18810	259	25	way.8	way.8	NOUN
ihlr-18810	259	26	8	8	NUM
ihlr-18810	259	27	in	in	ADP
ihlr-18810	259	28	response	response	NOUN
ihlr-18810	259	29	,	,	PUNCT
ihlr-18810	259	30	the	the	DET
ihlr-18810	259	31	fda	fda	PROPN
ihlr-18810	259	32	has	have	AUX
ihlr-18810	259	33	shifted	shift	VERB
ihlr-18810	259	34	toward	toward	ADP
ihlr-18810	259	35	the	the	DET
ihlr-18810	259	36	promulgation	promulgation	NOUN
ihlr-18810	259	37	of	of	ADP
ihlr-18810	259	38	nonbinding	nonbinding	NOUN
ihlr-18810	259	39	guidelines	guideline	NOUN
ihlr-18810	259	40	,	,	PUNCT
ihlr-18810	259	41	which	which	PRON
ihlr-18810	259	42	are	be	AUX
ihlr-18810	259	43	quicker	quick	ADJ
ihlr-18810	259	44	and	and	CCONJ
ihlr-18810	259	45	easier	easy	ADJ
ihlr-18810	259	46	to	to	PART
ihlr-18810	259	47	85	85	NUM
ihlr-18810	259	48	see	see	VERB
ihlr-18810	259	49	usv	usv	ADJ
ihlr-18810	259	50	pharm	pharm	PROPN
ihlr-18810	259	51	.	.	PUNCT
ihlr-18810	260	1	corp	corp	PROPN
ihlr-18810	260	2	.	.	PROPN
ihlr-18810	261	1	v.	v.	ADP
ihlr-18810	261	2	weinberger	weinberger	PROPN
ihlr-18810	261	3	,	,	PUNCT
ihlr-18810	261	4	412	412	NUM
ihlr-18810	261	5	u.s	u.s	PROPN
ihlr-18810	261	6	.	.	PROPN
ihlr-18810	261	7	655	655	NUM
ihlr-18810	261	8	(	(	PUNCT
ihlr-18810	261	9	1973	1973	NUM
ihlr-18810	261	10	)	)	PUNCT
ihlr-18810	261	11	;	;	PUNCT
ihlr-18810	261	12	weinberger	weinberger	PROPN
ihlr-18810	261	13	v.	v.	PROPN
ihlr-18810	261	14	bentex	bentex	PROPN
ihlr-18810	261	15	pharm	pharm	PROPN
ihlr-18810	261	16	.	.	PUNCT
ihlr-18810	261	17	,	,	PUNCT
ihlr-18810	261	18	inc	inc	PROPN
ihlr-18810	261	19	.	.	PROPN
ihlr-18810	261	20	,	,	PUNCT
ihlr-18810	261	21	412	412	NUM
ihlr-18810	261	22	u.s	u.s	PROPN
ihlr-18810	261	23	.	.	PROPN
ihlr-18810	261	24	645	645	NUM
ihlr-18810	261	25	(	(	PUNCT
ihlr-18810	261	26	1973	1973	NUM
ihlr-18810	261	27	)	)	PUNCT
ihlr-18810	261	28	;	;	PUNCT
ihlr-18810	261	29	ciba	ciba	PROPN
ihlr-18810	261	30	corp	corp	PROPN
ihlr-18810	261	31	.	.	PROPN
ihlr-18810	262	1	v.	v.	ADP
ihlr-18810	262	2	weinberger	weinberger	PROPN
ihlr-18810	262	3	,	,	PUNCT
ihlr-18810	262	4	412	412	NUM
ihlr-18810	262	5	u.s	u.s	PROPN
ihlr-18810	262	6	.	.	PROPN
ihlr-18810	262	7	640	640	NUM
ihlr-18810	262	8	(	(	PUNCT
ihlr-18810	262	9	1973	1973	NUM
ihlr-18810	262	10	)	)	PUNCT
ihlr-18810	262	11	;	;	PUNCT
ihlr-18810	262	12	weinberger	weinberger	PROPN
ihlr-18810	262	13	v.	v.	PROPN
ihlr-18810	262	14	hynson	hynson	PROPN
ihlr-18810	262	15	,	,	PUNCT
ihlr-18810	262	16	westcott	westcott	PROPN
ihlr-18810	262	17	&	&	CCONJ
ihlr-18810	262	18	dunning	dunning	PROPN
ihlr-18810	262	19	,	,	PUNCT
ihlr-18810	262	20	inc	inc	PROPN
ihlr-18810	262	21	.	.	PROPN
ihlr-18810	262	22	,	,	PUNCT
ihlr-18810	262	23	412	412	NUM
ihlr-18810	262	24	u.s	u.s	PROPN
ihlr-18810	262	25	.	.	PROPN
ihlr-18810	262	26	609	609	NUM
ihlr-18810	262	27	(	(	PUNCT
ihlr-18810	262	28	1973	1973	NUM
ihlr-18810	262	29	)	)	PUNCT
ihlr-18810	262	30	.	.	PUNCT
ihlr-18810	263	1	86	86	NUM
ihlr-18810	263	2	merrill	merrill	PROPN
ihlr-18810	263	3	&	&	CCONJ
ihlr-18810	263	4	watts	watts	PROPN
ihlr-18810	263	5	,	,	PUNCT
ihlr-18810	263	6	supra	supra	PROPN
ihlr-18810	263	7	note	note	NOUN
ihlr-18810	263	8	78	78	NUM
ihlr-18810	263	9	,	,	PUNCT
ihlr-18810	263	10	at	at	ADP
ihlr-18810	263	11	559	559	NUM
ihlr-18810	263	12	.	.	PUNCT
ihlr-18810	264	1	87	87	NUM
ihlr-18810	264	2	nat'l	nat'l	PROPN
ihlr-18810	264	3	nutritional	nutritional	ADJ
ihlr-18810	264	4	foods	food	NOUN
ihlr-18810	264	5	ass'n	ass'n	PROPN
ihlr-18810	264	6	v.	v.	ADP
ihlr-18810	264	7	weinberger	weinberger	PROPN
ihlr-18810	264	8	,	,	PUNCT
ihlr-18810	264	9	512	512	NUM
ihlr-18810	264	10	f.2d	f.2d	ADP
ihlr-18810	264	11	688	688	NUM
ihlr-18810	264	12	,	,	PUNCT
ihlr-18810	264	13	69798	69798	NUM
ihlr-18810	264	14	(	(	PUNCT
ihlr-18810	264	15	2d	2d	NUM
ihlr-18810	264	16	cir	cir	NOUN
ihlr-18810	264	17	.	.	PUNCT
ihlr-18810	264	18	1975	1975	NUM
ihlr-18810	264	19	)	)	PUNCT
ihlr-18810	264	20	.	.	PUNCT
ihlr-18810	265	1	88	88	NUM
ihlr-18810	265	2	lars	lars	PROPN
ihlr-18810	265	3	noah	noah	PROPN
ihlr-18810	265	4	,	,	PUNCT
ihlr-18810	265	5	the	the	DET
ihlr-18810	265	6	little	little	ADJ
ihlr-18810	265	7	agency	agency	NOUN
ihlr-18810	265	8	that	that	PRON
ihlr-18810	265	9	could	could	AUX
ihlr-18810	265	10	(	(	PUNCT
ihlr-18810	265	11	act	act	VERB
ihlr-18810	265	12	with	with	ADP
ihlr-18810	265	13	indifference	indifference	NOUN
ihlr-18810	265	14	to	to	ADP
ihlr-18810	265	15	constitutional	constitutional	ADJ
ihlr-18810	265	16	and	and	CCONJ
ihlr-18810	265	17	statutory	statutory	ADJ
ihlr-18810	265	18	strictures	stricture	NOUN
ihlr-18810	265	19	)	)	PUNCT
ihlr-18810	265	20	,	,	PUNCT
ihlr-18810	265	21	93	93	NUM
ihlr-18810	265	22	cornell	cornell	PROPN
ihlr-18810	265	23	l.	l.	PROPN
ihlr-18810	265	24	rev	rev	PROPN
ihlr-18810	265	25	.	.	PROPN
ihlr-18810	265	26	901	901	NUM
ihlr-18810	265	27	,	,	PUNCT
ihlr-18810	265	28	904	904	NUM
ihlr-18810	265	29	(	(	PUNCT
ihlr-18810	265	30	2008	2008	NUM
ihlr-18810	265	31	)	)	PUNCT
ihlr-18810	265	32	.	.	PUNCT
ihlr-18810	266	1	132	132	NUM
ihlr-18810	266	2	vol	vol	NOUN
ihlr-18810	266	3	.	.	PUNCT
ihlr-18810	267	1	10:1	10:1	NUM
ihlr-18810	267	2	510(k	510(k	X
ihlr-18810	267	3	)	)	PUNCT
ihlr-18810	267	4	clearance	clearance	NOUN
ihlr-18810	267	5	issue	issue	NOUN
ihlr-18810	267	6	.	.	PUNCT
ihlr-18810	268	1	one	one	NUM
ihlr-18810	268	2	example	example	NOUN
ihlr-18810	268	3	of	of	ADP
ihlr-18810	268	4	this	this	PRON
ihlr-18810	268	5	is	be	AUX
ihlr-18810	268	6	the	the	DET
ihlr-18810	268	7	fda	fda	PROPN
ihlr-18810	268	8	's	's	PART
ihlr-18810	268	9	decision	decision	NOUN
ihlr-18810	268	10	to	to	PART
ihlr-18810	268	11	,	,	PUNCT
ihlr-18810	268	12	rather	rather	ADV
ihlr-18810	268	13	than	than	ADP
ihlr-18810	268	14	amend	amend	VERB
ihlr-18810	268	15	its	its	PRON
ihlr-18810	268	16	(	(	PUNCT
ihlr-18810	268	17	at	at	ADP
ihlr-18810	268	18	that	that	DET
ihlr-18810	268	19	time	time	NOUN
ihlr-18810	268	20	)	)	PUNCT
ihlr-18810	268	21	twenty	twenty	NUM
ihlr-18810	268	22	-	-	PUNCT
ihlr-18810	268	23	five	five	NUM
ihlr-18810	268	24	year	year	NOUN
ihlr-18810	268	25	old	old	ADJ
ihlr-18810	268	26	regulations	regulation	NOUN
ihlr-18810	268	27	defining	define	VERB
ihlr-18810	268	28	and	and	CCONJ
ihlr-18810	268	29	outlining	outline	VERB
ihlr-18810	268	30	"	"	PUNCT
ihlr-18810	268	31	current	current	ADJ
ihlr-18810	268	32	"	"	PUNCT
ihlr-18810	268	33	good	good	ADJ
ihlr-18810	268	34	manufacturing	manufacturing	NOUN
ihlr-18810	268	35	practices	practice	NOUN
ihlr-18810	268	36	for	for	ADP
ihlr-18810	268	37	drugs	drug	NOUN
ihlr-18810	268	38	,	,	PUNCT
ihlr-18810	268	39	instead	instead	ADV
ihlr-18810	268	40	issue	issue	VERB
ihlr-18810	268	41	guidance	guidance	NOUN
ihlr-18810	268	42	for	for	ADP
ihlr-18810	268	43	the	the	DET
ihlr-18810	268	44	adoption	adoption	NOUN
ihlr-18810	268	45	of	of	ADP
ihlr-18810	268	46	new	new	ADJ
ihlr-18810	268	47	and	and	CCONJ
ihlr-18810	268	48	modern	modern	ADJ
ihlr-18810	268	49	quality	quality	NOUN
ihlr-18810	268	50	control	control	NOUN
ihlr-18810	268	51	technologies	technology	NOUN
ihlr-18810	268	52	by	by	ADP
ihlr-18810	268	53	the	the	DET
ihlr-18810	268	54	pharmaceutical	pharmaceutical	ADJ
ihlr-18810	268	55	industry.89	industry.89	NOUN
ihlr-18810	268	56	this	this	DET
ihlr-18810	268	57	growing	grow	VERB
ihlr-18810	268	58	dependence	dependence	NOUN
ihlr-18810	268	59	on	on	ADP
ihlr-18810	268	60	nonbinding	nonbinding	NOUN
ihlr-18810	268	61	guidelines	guideline	NOUN
ihlr-18810	268	62	presents	present	VERB
ihlr-18810	268	63	its	its	PRON
ihlr-18810	268	64	own	own	ADJ
ihlr-18810	268	65	problems	problem	NOUN
ihlr-18810	268	66	for	for	ADP
ihlr-18810	268	67	the	the	DET
ihlr-18810	268	68	agency	agency	NOUN
ihlr-18810	268	69	,	,	PUNCT
ihlr-18810	268	70	however	however	ADV
ihlr-18810	268	71	.	.	PUNCT
ihlr-18810	269	1	not	not	PART
ihlr-18810	269	2	only	only	ADV
ihlr-18810	269	3	can	can	AUX
ihlr-18810	269	4	these	these	DET
ihlr-18810	269	5	rules	rule	NOUN
ihlr-18810	269	6	escape	escape	VERB
ihlr-18810	269	7	the	the	DET
ihlr-18810	269	8	normal	normal	ADJ
ihlr-18810	269	9	procedural	procedural	ADJ
ihlr-18810	269	10	safeguards	safeguard	NOUN
ihlr-18810	269	11	set	set	VERB
ihlr-18810	269	12	in	in	ADP
ihlr-18810	269	13	place	place	NOUN
ihlr-18810	269	14	for	for	ADP
ihlr-18810	269	15	rulemaking	rulemaking	NOUN
ihlr-18810	269	16	,	,	PUNCT
ihlr-18810	269	17	but	but	CCONJ
ihlr-18810	269	18	they	they	PRON
ihlr-18810	269	19	also	also	ADV
ihlr-18810	269	20	allow	allow	VERB
ihlr-18810	269	21	the	the	DET
ihlr-18810	269	22	fda	fda	PROPN
ihlr-18810	269	23	to	to	PART
ihlr-18810	269	24	take	take	VERB
ihlr-18810	269	25	a	a	DET
ihlr-18810	269	26	stance	stance	NOUN
ihlr-18810	269	27	without	without	ADP
ihlr-18810	269	28	establishing	establish	VERB
ihlr-18810	269	29	a	a	DET
ihlr-18810	269	30	definitive	definitive	ADJ
ihlr-18810	269	31	position	position	NOUN
ihlr-18810	269	32	,	,	PUNCT
ihlr-18810	269	33	leaving	leave	VERB
ihlr-18810	269	34	the	the	DET
ihlr-18810	269	35	regulated	regulated	ADJ
ihlr-18810	269	36	entities	entity	NOUN
ihlr-18810	269	37	guessing	guess	VERB
ihlr-18810	269	38	about	about	ADP
ihlr-18810	269	39	their	their	PRON
ihlr-18810	269	40	own	own	ADJ
ihlr-18810	269	41	obligations	obligation	NOUN
ihlr-18810	269	42	and	and	CCONJ
ihlr-18810	269	43	rights	right	NOUN
ihlr-18810	269	44	under	under	ADP
ihlr-18810	269	45	the	the	DET
ihlr-18810	269	46	guidance	guidance	NOUN
ihlr-18810	269	47	.	.	PUNCT
ihlr-18810	270	1	90	90	NUM
ihlr-18810	270	2	congress	congress	PROPN
ihlr-18810	270	3	has	have	AUX
ihlr-18810	270	4	recognized	recognize	VERB
ihlr-18810	270	5	the	the	DET
ihlr-18810	270	6	importance	importance	NOUN
ihlr-18810	270	7	of	of	ADP
ihlr-18810	270	8	the	the	DET
ihlr-18810	270	9	ease	ease	NOUN
ihlr-18810	270	10	and	and	CCONJ
ihlr-18810	270	11	efficiency	efficiency	NOUN
ihlr-18810	270	12	these	these	DET
ihlr-18810	270	13	guidance	guidance	NOUN
ihlr-18810	270	14	documents	document	NOUN
ihlr-18810	270	15	offer	offer	VERB
ihlr-18810	270	16	administrative	administrative	ADJ
ihlr-18810	270	17	agencies	agency	NOUN
ihlr-18810	270	18	,	,	PUNCT
ihlr-18810	270	19	and	and	CCONJ
ihlr-18810	270	20	congress	congress	PROPN
ihlr-18810	270	21	even	even	ADV
ihlr-18810	270	22	endorsed	endorse	VERB
ihlr-18810	270	23	a	a	DET
ihlr-18810	270	24	greater	great	ADJ
ihlr-18810	270	25	reliance	reliance	NOUN
ihlr-18810	270	26	on	on	ADP
ihlr-18810	270	27	guidance	guidance	NOUN
ihlr-18810	270	28	documents	document	NOUN
ihlr-18810	270	29	issued	issue	VERB
ihlr-18810	270	30	by	by	ADP
ihlr-18810	270	31	agencies.91	agencies.91	NOUN
ihlr-18810	270	32	in	in	ADP
ihlr-18810	270	33	the	the	DET
ihlr-18810	270	34	regulation	regulation	NOUN
ihlr-18810	270	35	of	of	ADP
ihlr-18810	270	36	medical	medical	ADJ
ihlr-18810	270	37	devices	device	NOUN
ihlr-18810	270	38	,	,	PUNCT
ihlr-18810	270	39	the	the	DET
ihlr-18810	270	40	fda	fda	PROPN
ihlr-18810	270	41	can	can	AUX
ihlr-18810	270	42	issue	issue	VERB
ihlr-18810	270	43	rules	rule	NOUN
ihlr-18810	270	44	or	or	CCONJ
ihlr-18810	270	45	guidance	guidance	NOUN
ihlr-18810	270	46	pertaining	pertain	VERB
ihlr-18810	270	47	to	to	ADP
ihlr-18810	270	48	any	any	DET
ihlr-18810	270	49	aspects	aspect	NOUN
ihlr-18810	270	50	of	of	ADP
ihlr-18810	270	51	the	the	DET
ihlr-18810	270	52	device	device	NOUN
ihlr-18810	270	53	that	that	PRON
ihlr-18810	270	54	fall	fall	VERB
ihlr-18810	270	55	within	within	ADP
ihlr-18810	270	56	the	the	DET
ihlr-18810	270	57	scope	scope	NOUN
ihlr-18810	270	58	of	of	ADP
ihlr-18810	270	59	the	the	DET
ihlr-18810	270	60	fdca	fdca	NOUN
ihlr-18810	270	61	which	which	PRON
ihlr-18810	270	62	,	,	PUNCT
ihlr-18810	270	63	due	due	ADP
ihlr-18810	270	64	to	to	ADP
ihlr-18810	270	65	the	the	DET
ihlr-18810	270	66	ability	ability	NOUN
ihlr-18810	270	67	of	of	ADP
ihlr-18810	270	68	medical	medical	ADJ
ihlr-18810	270	69	devices	device	NOUN
ihlr-18810	270	70	to	to	PART
ihlr-18810	270	71	present	present	VERB
ihlr-18810	270	72	a	a	DET
ihlr-18810	270	73	risk	risk	NOUN
ihlr-18810	270	74	of	of	ADP
ihlr-18810	270	75	injury	injury	NOUN
ihlr-18810	270	76	,	,	PUNCT
ihlr-18810	270	77	can	can	AUX
ihlr-18810	270	78	be	be	AUX
ihlr-18810	270	79	quite	quite	ADV
ihlr-18810	270	80	extensive	extensive	ADJ
ihlr-18810	270	81	depending	depend	VERB
ihlr-18810	270	82	on	on	ADP
ihlr-18810	270	83	the	the	DET
ihlr-18810	270	84	device	device	NOUN
ihlr-18810	270	85	.	.	PUNCT
ihlr-18810	271	1	for	for	ADP
ihlr-18810	271	2	the	the	DET
ihlr-18810	271	3	purposes	purpose	NOUN
ihlr-18810	271	4	of	of	ADP
ihlr-18810	271	5	the	the	DET
ihlr-18810	271	6	rest	rest	NOUN
ihlr-18810	271	7	of	of	ADP
ihlr-18810	271	8	this	this	DET
ihlr-18810	271	9	paper	paper	NOUN
ihlr-18810	271	10	,	,	PUNCT
ihlr-18810	271	11	"	"	PUNCT
ihlr-18810	271	12	rule	rule	NOUN
ihlr-18810	271	13	"	"	PUNCT
ihlr-18810	271	14	refers	refer	VERB
ihlr-18810	271	15	to	to	ADP
ihlr-18810	271	16	a	a	DET
ihlr-18810	271	17	regulation	regulation	NOUN
ihlr-18810	271	18	that	that	PRON
ihlr-18810	271	19	has	have	VERB
ihlr-18810	271	20	the	the	DET
ihlr-18810	271	21	force	force	NOUN
ihlr-18810	271	22	of	of	ADP
ihlr-18810	271	23	law	law	NOUN
ihlr-18810	271	24	;	;	PUNCT
ihlr-18810	271	25	one	one	NUM
ihlr-18810	271	26	that	that	PRON
ihlr-18810	271	27	subjects	subject	VERB
ihlr-18810	271	28	a	a	DET
ihlr-18810	271	29	violator	violator	NOUN
ihlr-18810	271	30	to	to	ADP
ihlr-18810	271	31	sanctions	sanction	NOUN
ihlr-18810	271	32	,	,	PUNCT
ihlr-18810	271	33	penalties	penalty	NOUN
ihlr-18810	271	34	,	,	PUNCT
ihlr-18810	271	35	or	or	CCONJ
ihlr-18810	271	36	other	other	ADJ
ihlr-18810	271	37	legal	legal	ADJ
ihlr-18810	271	38	consequences	consequence	NOUN
ihlr-18810	271	39	.	.	PUNCT
ihlr-18810	272	1	92	92	NUM
ihlr-18810	272	2	some	some	DET
ihlr-18810	272	3	examples	example	NOUN
ihlr-18810	272	4	of	of	ADP
ihlr-18810	272	5	rulemaking	rulemaking	NOUN
ihlr-18810	272	6	include	include	VERB
ihlr-18810	272	7	the	the	DET
ihlr-18810	272	8	general	general	ADJ
ihlr-18810	272	9	regulatory	regulatory	ADJ
ihlr-18810	272	10	controls	control	NOUN
ihlr-18810	272	11	of	of	ADP
ihlr-18810	272	12	safety	safety	NOUN
ihlr-18810	272	13	and	and	CCONJ
ihlr-18810	272	14	effectiveness93	effectiveness93	VERB
ihlr-18810	272	15	such	such	ADJ
ihlr-18810	272	16	as	as	ADP
ihlr-18810	272	17	regulations	regulation	NOUN
ihlr-18810	272	18	pertaining	pertain	VERB
ihlr-18810	272	19	to	to	ADP
ihlr-18810	272	20	gmp	gmp	PROPN
ihlr-18810	272	21	and	and	CCONJ
ihlr-18810	272	22	labeling	labeling	NOUN
ihlr-18810	272	23	,	,	PUNCT
ihlr-18810	272	24	postmarket	postmarket	ADJ
ihlr-18810	272	25	surveillance	surveillance	NOUN
ihlr-18810	272	26	,	,	PUNCT
ihlr-18810	272	27	and	and	CCONJ
ihlr-18810	272	28	adverse	adverse	ADJ
ihlr-18810	272	29	experience	experience	NOUN
ihlr-18810	272	30	reporting	report	VERB
ihlr-18810	272	31	(	(	PUNCT
ihlr-18810	272	32	discussed	discuss	VERB
ihlr-18810	272	33	in	in	ADP
ihlr-18810	272	34	greater	great	ADJ
ihlr-18810	272	35	detail	detail	NOUN
ihlr-18810	272	36	below).94	below).94	PROPN
ihlr-18810	272	37	for	for	ADP
ihlr-18810	272	38	certain	certain	ADJ
ihlr-18810	272	39	higher	high	ADJ
ihlr-18810	272	40	-	-	PUNCT
ihlr-18810	272	41	risk	risk	NOUN
ihlr-18810	272	42	devices	device	NOUN
ihlr-18810	272	43	,	,	PUNCT
ihlr-18810	272	44	regulations	regulation	NOUN
ihlr-18810	272	45	pertaining	pertain	VERB
ihlr-18810	272	46	to	to	ADP
ihlr-18810	272	47	89	89	NUM
ihlr-18810	272	48	i	i	PRON
ihlr-18810	272	49	d.	d.	PROPN
ihlr-18810	272	50	at	at	ADP
ihlr-18810	272	51	904	904	NUM
ihlr-18810	272	52	-	-	SYM
ihlr-18810	272	53	5	5	NUM
ihlr-18810	272	54	;	;	PUNCT
ihlr-18810	272	55	leila	leila	PROPN
ihlr-18810	272	56	abboud	abboud	PROPN
ihlr-18810	272	57	&	&	CCONJ
ihlr-18810	272	58	scott	scott	PROPN
ihlr-18810	272	59	hensley	hensley	PROPN
ihlr-18810	272	60	,	,	PUNCT
ihlr-18810	272	61	factory	factory	NOUN
ihlr-18810	272	62	shift	shift	NOUN
ihlr-18810	272	63	:	:	PUNCT
ihlr-18810	272	64	new	new	ADJ
ihlr-18810	272	65	prescription	prescription	NOUN
ihlr-18810	272	66	for	for	ADP
ihlr-18810	272	67	drug	drug	NOUN
ihlr-18810	272	68	makers	maker	NOUN
ihlr-18810	272	69	:	:	PUNCT
ihlr-18810	272	70	update	update	VERB
ihlr-18810	272	71	the	the	DET
ihlr-18810	272	72	plants	plant	NOUN
ihlr-18810	272	73	;	;	PUNCT
ihlr-18810	272	74	after	after	ADP
ihlr-18810	272	75	years	year	NOUN
ihlr-18810	272	76	of	of	ADP
ihlr-18810	272	77	neglect	neglect	NOUN
ihlr-18810	272	78	,	,	PUNCT
ihlr-18810	272	79	industry	industry	NOUN
ihlr-18810	272	80	focuses	focus	VERB
ihlr-18810	272	81	on	on	ADP
ihlr-18810	272	82	manufacturing	manufacturing	NOUN
ihlr-18810	272	83	;	;	PUNCT
ihlr-18810	272	84	fda	fda	PROPN
ihlr-18810	272	85	acts	act	VERB
ihlr-18810	272	86	as	as	ADP
ihlr-18810	272	87	a	a	DET
ihlr-18810	272	88	catalyst	catalyst	NOUN
ihlr-18810	272	89	;	;	PUNCT
ihlr-18810	272	90	the	the	DET
ihlr-18810	272	91	three	three	NUM
ihlr-18810	272	92	-	-	PUNCT
ihlr-18810	272	93	story	story	NOUN
ihlr-18810	272	94	blender	blender	NOUN
ihlr-18810	272	95	,	,	PUNCT
ihlr-18810	272	96	wall	wall	PROPN
ihlr-18810	272	97	st	st	PROPN
ihlr-18810	272	98	.	.	PROPN
ihlr-18810	272	99	j	j	PROPN
ihlr-18810	272	100	,	,	PUNCT
ihlr-18810	272	101	sept	sept	PROPN
ihlr-18810	272	102	.	.	PROPN
ihlr-18810	272	103	3	3	NUM
ihlr-18810	272	104	,	,	PUNCT
ihlr-18810	272	105	2003	2003	NUM
ihlr-18810	272	106	,	,	PUNCT
ihlr-18810	272	107	at	at	ADP
ihlr-18810	272	108	al	al	PROPN
ihlr-18810	272	109	.	.	PROPN
ihlr-18810	272	110	90	90	NUM
ihlr-18810	272	111	noah	noah	PROPN
ihlr-18810	272	112	,	,	PUNCT
ihlr-18810	272	113	supra	supra	PROPN
ihlr-18810	272	114	note	note	PROPN
ihlr-18810	272	115	88	88	NUM
ihlr-18810	272	116	,	,	PUNCT
ihlr-18810	272	117	at	at	ADP
ihlr-18810	272	118	905	905	NUM
ihlr-18810	272	119	.	.	PUNCT
ihlr-18810	273	1	91	91	NUM
ihlr-18810	274	1	i	i	PRON
ihlr-18810	274	2	d.	d.	PROPN
ihlr-18810	274	3	92	92	NUM
ihlr-18810	274	4	see	see	VERB
ihlr-18810	274	5	generally	generally	ADV
ihlr-18810	274	6	merril	merril	PROPN
ihlr-18810	274	7	&	&	CCONJ
ihlr-18810	274	8	watts	watts	PROPN
ihlr-18810	274	9	,	,	PUNCT
ihlr-18810	274	10	supra	supra	PROPN
ihlr-18810	274	11	note	note	NOUN
ihlr-18810	274	12	78	78	NUM
ihlr-18810	274	13	,	,	PUNCT
ihlr-18810	274	14	at	at	ADP
ihlr-18810	274	15	515	515	NUM
ihlr-18810	274	16	-	-	SYM
ihlr-18810	274	17	16	16	NUM
ihlr-18810	274	18	(	(	PUNCT
ihlr-18810	274	19	discussing	discuss	VERB
ihlr-18810	274	20	legislative	legislative	ADJ
ihlr-18810	274	21	history	history	NOUN
ihlr-18810	274	22	granting	grant	VERB
ihlr-18810	274	23	rulemaking	rulemake	VERB
ihlr-18810	274	24	power	power	NOUN
ihlr-18810	274	25	to	to	ADP
ihlr-18810	274	26	secretary	secretary	NOUN
ihlr-18810	274	27	of	of	ADP
ihlr-18810	274	28	the	the	DET
ihlr-18810	274	29	fda	fda	PROPN
ihlr-18810	274	30	)	)	PUNCT
ihlr-18810	274	31	.	.	PUNCT
ihlr-18810	275	1	93	93	NUM
ihlr-18810	275	2	21	21	NUM
ihlr-18810	275	3	u.s.c	u.s.c	NOUN
ihlr-18810	275	4	.	.	PUNCT
ihlr-18810	276	1	§	§	PROPN
ihlr-18810	276	2	360c(a)(1)(a)(ii)(ii	360c(a)(1)(a)(ii)(ii	NUM
ihlr-18810	276	3	)	)	PUNCT
ihlr-18810	276	4	(	(	PUNCT
ihlr-18810	276	5	2012	2012	NUM
ihlr-18810	276	6	)	)	PUNCT
ihlr-18810	276	7	.	.	PUNCT
ihlr-18810	277	1	94	94	NUM
ihlr-18810	277	2	general	general	ADJ
ihlr-18810	277	3	and	and	CCONJ
ihlr-18810	277	4	special	special	ADJ
ihlr-18810	277	5	controls	control	NOUN
ihlr-18810	277	6	,	,	PUNCT
ihlr-18810	277	7	supra	supra	PROPN
ihlr-18810	277	8	note	note	NOUN
ihlr-18810	277	9	17	17	NUM
ihlr-18810	277	10	.	.	PUNCT
ihlr-18810	277	11	2013	2013	NUM
ihlr-18810	277	12	133	133	NUM
ihlr-18810	277	13	indiana	indiana	PROPN
ihlr-18810	277	14	health	health	PROPN
ihlr-18810	277	15	law	law	PROPN
ihlr-18810	277	16	review	review	VERB
ihlr-18810	277	17	specific	specific	ADJ
ihlr-18810	277	18	aspects	aspect	NOUN
ihlr-18810	277	19	of	of	ADP
ihlr-18810	277	20	the	the	DET
ihlr-18810	277	21	design	design	NOUN
ihlr-18810	277	22	or	or	CCONJ
ihlr-18810	277	23	manufacture	manufacture	NOUN
ihlr-18810	277	24	of	of	ADP
ihlr-18810	277	25	the	the	DET
ihlr-18810	277	26	devices	device	NOUN
ihlr-18810	277	27	may	may	AUX
ihlr-18810	277	28	also	also	ADV
ihlr-18810	277	29	be	be	AUX
ihlr-18810	277	30	available	available	ADJ
ihlr-18810	277	31	.	.	PUNCT
ihlr-18810	278	1	there	there	PRON
ihlr-18810	278	2	have	have	AUX
ihlr-18810	278	3	been	be	AUX
ihlr-18810	278	4	times	time	NOUN
ihlr-18810	278	5	when	when	SCONJ
ihlr-18810	278	6	the	the	DET
ihlr-18810	278	7	fda	fda	PROPN
ihlr-18810	278	8	has	have	AUX
ihlr-18810	278	9	issued	issue	VERB
ihlr-18810	278	10	regulations	regulation	NOUN
ihlr-18810	278	11	for	for	ADP
ihlr-18810	278	12	specific	specific	ADJ
ihlr-18810	278	13	devices	device	NOUN
ihlr-18810	278	14	which	which	PRON
ihlr-18810	278	15	impose	impose	VERB
ihlr-18810	278	16	particular	particular	ADJ
ihlr-18810	278	17	labeling	labeling	NOUN
ihlr-18810	278	18	or	or	CCONJ
ihlr-18810	278	19	warning	warn	VERB
ihlr-18810	278	20	requirements.95	requirements.95	NOUN
ihlr-18810	278	21	an	an	DET
ihlr-18810	278	22	ex	ex	NOUN
ihlr-18810	278	23	-	-	NOUN
ihlr-18810	278	24	ample	ample	ADJ
ihlr-18810	278	25	of	of	ADP
ihlr-18810	278	26	this	this	PRON
ihlr-18810	278	27	is	be	AUX
ihlr-18810	278	28	the	the	DET
ihlr-18810	278	29	fda	fda	PROPN
ihlr-18810	278	30	's	's	PART
ihlr-18810	278	31	requirement	requirement	NOUN
ihlr-18810	278	32	96	96	NUM
ihlr-18810	278	33	that	that	SCONJ
ihlr-18810	278	34	tampons	tampon	NOUN
ihlr-18810	278	35	include	include	VERB
ihlr-18810	278	36	labeling	labeling	NOUN
ihlr-18810	278	37	that	that	PRON
ihlr-18810	278	38	warns	warn	VERB
ihlr-18810	278	39	customers	customer	NOUN
ihlr-18810	278	40	of	of	ADP
ihlr-18810	278	41	the	the	DET
ihlr-18810	278	42	dangers	danger	NOUN
ihlr-18810	278	43	of	of	ADP
ihlr-18810	278	44	toxic	toxic	ADJ
ihlr-18810	278	45	shock	shock	NOUN
ihlr-18810	278	46	syndrome	syndrome	NOUN
ihlr-18810	278	47	and	and	CCONJ
ihlr-18810	278	48	how	how	SCONJ
ihlr-18810	278	49	it	it	PRON
ihlr-18810	278	50	can	can	AUX
ihlr-18810	278	51	be	be	AUX
ihlr-18810	278	52	avoided	avoid	VERB
ihlr-18810	278	53	.	.	PUNCT
ihlr-18810	279	1	97	97	NUM
ihlr-18810	279	2	such	such	ADJ
ihlr-18810	279	3	requirements	requirement	NOUN
ihlr-18810	279	4	will	will	AUX
ihlr-18810	279	5	not	not	PART
ihlr-18810	279	6	be	be	AUX
ihlr-18810	279	7	uniformly	uniformly	ADV
ihlr-18810	279	8	applied	apply	VERB
ihlr-18810	279	9	to	to	ADP
ihlr-18810	279	10	all	all	DET
ihlr-18810	279	11	classes	class	NOUN
ihlr-18810	279	12	of	of	ADP
ihlr-18810	279	13	devices	device	NOUN
ihlr-18810	279	14	or	or	CCONJ
ihlr-18810	279	15	all	all	DET
ihlr-18810	279	16	devices	device	NOUN
ihlr-18810	279	17	within	within	ADP
ihlr-18810	279	18	a	a	DET
ihlr-18810	279	19	class	class	NOUN
ihlr-18810	279	20	,	,	PUNCT
ihlr-18810	279	21	but	but	CCONJ
ihlr-18810	279	22	may	may	AUX
ihlr-18810	279	23	be	be	AUX
ihlr-18810	279	24	imposed	impose	VERB
ihlr-18810	279	25	on	on	ADP
ihlr-18810	279	26	specific	specific	ADJ
ihlr-18810	279	27	devices	device	NOUN
ihlr-18810	279	28	or	or	CCONJ
ihlr-18810	279	29	types	type	NOUN
ihlr-18810	279	30	of	of	ADP
ihlr-18810	279	31	devices	device	NOUN
ihlr-18810	279	32	.	.	PUNCT
ihlr-18810	280	1	in	in	ADP
ihlr-18810	280	2	contrast	contrast	NOUN
ihlr-18810	280	3	,	,	PUNCT
ihlr-18810	280	4	"	"	PUNCT
ihlr-18810	280	5	guidance	guidance	NOUN
ihlr-18810	280	6	"	"	PUNCT
ihlr-18810	280	7	refers	refer	VERB
ihlr-18810	280	8	to	to	ADP
ihlr-18810	280	9	documents	document	NOUN
ihlr-18810	280	10	that	that	PRON
ihlr-18810	280	11	are	be	AUX
ihlr-18810	280	12	prepared	prepare	VERB
ihlr-18810	280	13	for	for	ADP
ihlr-18810	280	14	fda	fda	PROPN
ihlr-18810	280	15	staff	staff	NOUN
ihlr-18810	280	16	,	,	PUNCT
ihlr-18810	280	17	applicants	applicant	NOUN
ihlr-18810	280	18	or	or	CCONJ
ihlr-18810	280	19	sponsors	sponsor	NOUN
ihlr-18810	280	20	of	of	ADP
ihlr-18810	280	21	devices	device	NOUN
ihlr-18810	280	22	,	,	PUNCT
ihlr-18810	280	23	and	and	CCONJ
ihlr-18810	280	24	the	the	DET
ihlr-18810	280	25	general	general	ADJ
ihlr-18810	280	26	public	public	NOUN
ihlr-18810	280	27	that	that	PRON
ihlr-18810	280	28	describe	describe	VERB
ihlr-18810	280	29	the	the	DET
ihlr-18810	280	30	fda	fda	PROPN
ihlr-18810	280	31	's	's	PART
ihlr-18810	280	32	policy	policy	NOUN
ihlr-18810	280	33	on	on	ADP
ihlr-18810	280	34	or	or	CCONJ
ihlr-18810	280	35	interpretation	interpretation	NOUN
ihlr-18810	280	36	of	of	ADP
ihlr-18810	280	37	a	a	DET
ihlr-18810	280	38	regulatory	regulatory	ADJ
ihlr-18810	280	39	issue.98	issue.98	ADJ
ihlr-18810	280	40	guidance	guidance	NOUN
ihlr-18810	280	41	documents	document	NOUN
ihlr-18810	280	42	can	can	AUX
ihlr-18810	280	43	relate	relate	VERB
ihlr-18810	280	44	to	to	ADP
ihlr-18810	280	45	the	the	DET
ihlr-18810	280	46	"	"	PUNCT
ihlr-18810	280	47	design	design	NOUN
ihlr-18810	280	48	,	,	PUNCT
ihlr-18810	280	49	production	production	NOUN
ihlr-18810	280	50	,	,	PUNCT
ihlr-18810	280	51	labeling	labeling	NOUN
ihlr-18810	280	52	,	,	PUNCT
ihlr-18810	280	53	promotion	promotion	NOUN
ihlr-18810	280	54	,	,	PUNCT
ihlr-18810	280	55	manufacturing	manufacturing	NOUN
ihlr-18810	280	56	,	,	PUNCT
ihlr-18810	280	57	and	and	CCONJ
ihlr-18810	280	58	testing	testing	NOUN
ihlr-18810	280	59	of	of	ADP
ihlr-18810	280	60	regulated	regulated	ADJ
ihlr-18810	280	61	products	product	NOUN
ihlr-18810	280	62	;	;	PUNCT
ihlr-18810	280	63	the	the	DET
ihlr-18810	280	64	processing	processing	NOUN
ihlr-18810	280	65	,	,	PUNCT
ihlr-18810	280	66	content	content	NOUN
ihlr-18810	280	67	,	,	PUNCT
ihlr-18810	280	68	and	and	CCONJ
ihlr-18810	280	69	evaluation	evaluation	NOUN
ihlr-18810	280	70	or	or	CCONJ
ihlr-18810	280	71	approval	approval	NOUN
ihlr-18810	280	72	of	of	ADP
ihlr-18810	280	73	submissions	submission	NOUN
ihlr-18810	280	74	;	;	PUNCT
ihlr-18810	280	75	and	and	CCONJ
ihlr-18810	280	76	inspection	inspection	NOUN
ihlr-18810	280	77	and	and	CCONJ
ihlr-18810	280	78	enforcement	enforcement	NOUN
ihlr-18810	280	79	policies	policy	NOUN
ihlr-18810	280	80	.	.	PUNCT
ihlr-18810	280	81	"	"	PUNCT
ihlr-18810	281	1	99	99	NUM
ihlr-18810	281	2	guidance	guidance	NOUN
ihlr-18810	281	3	documents	document	NOUN
ihlr-18810	281	4	are	be	AUX
ihlr-18810	281	5	helpful	helpful	ADJ
ihlr-18810	281	6	and	and	CCONJ
ihlr-18810	281	7	persuasive	persuasive	ADJ
ihlr-18810	281	8	,	,	PUNCT
ihlr-18810	281	9	and	and	CCONJ
ihlr-18810	281	10	can	can	AUX
ihlr-18810	281	11	make	make	VERB
ihlr-18810	281	12	the	the	DET
ihlr-18810	281	13	application	application	NOUN
ihlr-18810	281	14	and	and	CCONJ
ihlr-18810	281	15	clearance	clearance	NOUN
ihlr-18810	281	16	process	process	NOUN
ihlr-18810	281	17	more	more	ADV
ihlr-18810	281	18	efficient	efficient	ADJ
ihlr-18810	281	19	when	when	SCONJ
ihlr-18810	281	20	followed	follow	VERB
ihlr-18810	281	21	,	,	PUNCT
ihlr-18810	281	22	but	but	CCONJ
ihlr-18810	281	23	do	do	AUX
ihlr-18810	281	24	not	not	PART
ihlr-18810	281	25	have	have	VERB
ihlr-18810	281	26	the	the	DET
ihlr-18810	281	27	same	same	ADJ
ihlr-18810	281	28	effect	effect	NOUN
ihlr-18810	281	29	as	as	ADP
ihlr-18810	281	30	regulations	regulation	NOUN
ihlr-18810	281	31	and	and	CCONJ
ihlr-18810	281	32	do	do	AUX
ihlr-18810	281	33	not	not	PART
ihlr-18810	281	34	amount	amount	VERB
ihlr-18810	281	35	to	to	ADP
ihlr-18810	281	36	actual	actual	ADJ
ihlr-18810	281	37	legal	legal	ADJ
ihlr-18810	281	38	requirements	requirement	NOUN
ihlr-18810	281	39	.	.	PUNCT
ihlr-18810	282	1	2	2	X
ihlr-18810	282	2	.	.	X
ihlr-18810	282	3	reporting	reporting	NOUN
ihlr-18810	282	4	and	and	CCONJ
ihlr-18810	282	5	postmarket	postmarket	ADJ
ihlr-18810	282	6	surveillance	surveillance	NOUN
ihlr-18810	282	7	due	due	ADP
ihlr-18810	282	8	to	to	ADP
ihlr-18810	282	9	the	the	DET
ihlr-18810	282	10	fact	fact	NOUN
ihlr-18810	282	11	that	that	SCONJ
ihlr-18810	282	12	devices	device	NOUN
ihlr-18810	282	13	brought	bring	VERB
ihlr-18810	282	14	to	to	ADP
ihlr-18810	282	15	market	market	NOUN
ihlr-18810	282	16	through	through	ADP
ihlr-18810	282	17	the	the	DET
ihlr-18810	282	18	510(k	510(k	PROPN
ihlr-18810	282	19	)	)	PUNCT
ihlr-18810	282	20	clearance	clearance	NOUN
ihlr-18810	282	21	process	process	NOUN
ihlr-18810	282	22	avoided	avoid	VERB
ihlr-18810	282	23	any	any	DET
ihlr-18810	282	24	kind	kind	NOUN
ihlr-18810	282	25	of	of	ADP
ihlr-18810	282	26	premarket	premarket	NOUN
ihlr-18810	282	27	review	review	NOUN
ihlr-18810	282	28	,	,	PUNCT
ihlr-18810	282	29	a	a	DET
ihlr-18810	282	30	strong	strong	ADJ
ihlr-18810	282	31	postmarket	postmarket	ADJ
ihlr-18810	282	32	surveillance	surveillance	NOUN
ihlr-18810	282	33	system	system	NOUN
ihlr-18810	282	34	is	be	AUX
ihlr-18810	282	35	95	95	NUM
ihlr-18810	282	36	see	see	NOUN
ihlr-18810	282	37	21	21	NUM
ihlr-18810	282	38	c.f.r	c.f.r	NOUN
ihlr-18810	282	39	.	.	PUNCT
ihlr-18810	283	1	§	§	PROPN
ihlr-18810	283	2	801.437	801.437	NUM
ihlr-18810	283	3	(	(	PUNCT
ihlr-18810	283	4	2012	2012	NUM
ihlr-18810	283	5	)	)	PUNCT
ihlr-18810	283	6	(	(	PUNCT
ihlr-18810	283	7	providing	provide	VERB
ihlr-18810	283	8	labeling	labeling	NOUN
ihlr-18810	283	9	requirements	requirement	NOUN
ihlr-18810	283	10	for	for	ADP
ihlr-18810	283	11	allergy	allergy	NOUN
ihlr-18810	283	12	warning	warn	VERB
ihlr-18810	283	13	on	on	ADP
ihlr-18810	283	14	latex	latex	NOUN
ihlr-18810	283	15	gloves	glove	NOUN
ihlr-18810	283	16	)	)	PUNCT
ihlr-18810	283	17	;	;	PUNCT
ihlr-18810	283	18	center	center	NOUN
ihlr-18810	283	19	for	for	ADP
ihlr-18810	283	20	devices	device	NOUN
ihlr-18810	283	21	and	and	CCONJ
ihlr-18810	283	22	radiological	radiological	ADJ
ihlr-18810	283	23	health	health	NOUN
ihlr-18810	283	24	,	,	PUNCT
ihlr-18810	283	25	guidance	guidance	NOUN
ihlr-18810	283	26	for	for	ADP
ihlr-18810	283	27	industry	industry	NOUN
ihlr-18810	283	28	and	and	CCONJ
ihlr-18810	283	29	food	food	NOUN
ihlr-18810	283	30	and	and	CCONJ
ihlr-18810	283	31	drug	drug	PROPN
ihlr-18810	283	32	administration	administration	NOUN
ihlr-18810	283	33	staff	staff	NOUN
ihlr-18810	283	34	:	:	PUNCT
ihlr-18810	283	35	contact	contact	NOUN
ihlr-18810	283	36	lens	lens	NOUN
ihlr-18810	283	37	care	care	NOUN
ihlr-18810	283	38	products	product	NOUN
ihlr-18810	283	39	labeling	labeling	NOUN
ihlr-18810	283	40	(	(	PUNCT
ihlr-18810	283	41	2010	2010	NUM
ihlr-18810	283	42	)	)	PUNCT
ihlr-18810	283	43	,	,	PUNCT
ihlr-18810	283	44	available	available	ADJ
ihlr-18810	283	45	at	at	ADP
ihlr-18810	283	46	http://	http://	PROPN
ihlr-18810	283	47	www.fda.gov/downloads/medicaldevices/	www.fda.gov/downloads/medicaldevices/	PROPN
ihlr-18810	283	48	deviceregulationandguidance	deviceregulationandguidance	PROPN
ihlr-18810	283	49	/	/	SYM
ihlr-18810	283	50	guidancedocuments	guidancedocuments	PROPN
ihlr-18810	283	51	/	/	SYM
ihlr-18810	283	52	ucm223665.pdf	ucm223665.pdf	PROPN
ihlr-18810	283	53	(	(	PUNCT
ihlr-18810	283	54	providing	provide	VERB
ihlr-18810	283	55	guidance	guidance	NOUN
ihlr-18810	283	56	on	on	ADP
ihlr-18810	283	57	labeling	labeling	NOUN
ihlr-18810	283	58	and	and	CCONJ
ihlr-18810	283	59	package	package	NOUN
ihlr-18810	283	60	insert	insert	NOUN
ihlr-18810	283	61	requirements	requirement	NOUN
ihlr-18810	283	62	for	for	ADP
ihlr-18810	283	63	contact	contact	NOUN
ihlr-18810	283	64	lens	lens	NOUN
ihlr-18810	283	65	solution	solution	NOUN
ihlr-18810	283	66	)	)	PUNCT
ihlr-18810	283	67	.	.	PUNCT
ihlr-18810	284	1	96	96	NUM
ihlr-18810	284	2	21	21	NUM
ihlr-18810	284	3	c.f.r	c.f.r	NOUN
ihlr-18810	284	4	.	.	PUNCT
ihlr-18810	285	1	§	§	PROPN
ihlr-18810	285	2	801.430	801.430	NUM
ihlr-18810	285	3	(	(	PUNCT
ihlr-18810	285	4	2012	2012	NUM
ihlr-18810	285	5	)	)	PUNCT
ihlr-18810	285	6	.	.	PUNCT
ihlr-18810	286	1	97	97	NUM
ihlr-18810	286	2	nat'l	nat'l	PROPN
ihlr-18810	286	3	bank	bank	PROPN
ihlr-18810	286	4	of	of	ADP
ihlr-18810	286	5	commerce	commerce	PROPN
ihlr-18810	286	6	v.	v.	ADP
ihlr-18810	286	7	kimberly	kimberly	PROPN
ihlr-18810	286	8	-	-	PUNCT
ihlr-18810	286	9	clark	clark	PROPN
ihlr-18810	286	10	corp	corp	PROPN
ihlr-18810	286	11	.	.	PROPN
ihlr-18810	286	12	,	,	PUNCT
ihlr-18810	286	13	38	38	NUM
ihlr-18810	286	14	f.3d	f.3d	NUM
ihlr-18810	286	15	988	988	NUM
ihlr-18810	286	16	,	,	PUNCT
ihlr-18810	286	17	990	990	NUM
ihlr-18810	286	18	(	(	PUNCT
ihlr-18810	286	19	8th	8th	ADJ
ihlr-18810	286	20	cir	cir	NOUN
ihlr-18810	286	21	.	.	PROPN
ihlr-18810	286	22	1994	1994	NUM
ihlr-18810	286	23	)	)	PUNCT
ihlr-18810	286	24	.	.	PUNCT
ihlr-18810	287	1	98	98	NUM
ihlr-18810	287	2	21	21	NUM
ihlr-18810	287	3	c.f.r	c.f.r	NOUN
ihlr-18810	287	4	.	.	PUNCT
ihlr-18810	288	1	§	§	PROPN
ihlr-18810	288	2	10.115	10.115	NUM
ihlr-18810	288	3	(	(	PUNCT
ihlr-18810	288	4	2012	2012	NUM
ihlr-18810	288	5	)	)	PUNCT
ihlr-18810	288	6	.	.	PUNCT
ihlr-18810	289	1	9s	9s	NUM
ihlr-18810	290	1	i	i	PRON
ihlr-18810	290	2	d.	d.	NOUN
ihlr-18810	290	3	134	134	NUM
ihlr-18810	290	4	vol	vol	NOUN
ihlr-18810	290	5	.	.	PUNCT
ihlr-18810	291	1	10:1	10:1	NUM
ihlr-18810	291	2	510(k	510(k	X
ihlr-18810	291	3	)	)	PUNCT
ihlr-18810	291	4	clearance	clearance	NOUN
ihlr-18810	291	5	important	important	ADJ
ihlr-18810	291	6	to	to	PART
ihlr-18810	291	7	ensure	ensure	VERB
ihlr-18810	291	8	the	the	DET
ihlr-18810	291	9	safety	safety	NOUN
ihlr-18810	291	10	of	of	ADP
ihlr-18810	291	11	medical	medical	ADJ
ihlr-18810	291	12	devices	device	NOUN
ihlr-18810	291	13	.	.	PUNCT
ihlr-18810	292	1	postmarket	postmarket	ADJ
ihlr-18810	292	2	surveillance	surveillance	NOUN
ihlr-18810	292	3	includes	include	VERB
ihlr-18810	292	4	a	a	DET
ihlr-18810	292	5	variety	variety	NOUN
ihlr-18810	292	6	of	of	ADP
ihlr-18810	292	7	programs	program	NOUN
ihlr-18810	292	8	,	,	PUNCT
ihlr-18810	292	9	including	include	VERB
ihlr-18810	292	10	medical	medical	ADJ
ihlr-18810	292	11	device	device	NOUN
ihlr-18810	292	12	reporting	reporting	NOUN
ihlr-18810	292	13	(	(	PUNCT
ihlr-18810	292	14	mdr	mdr	NOUN
ihlr-18810	292	15	)	)	PUNCT
ihlr-18810	292	16	by	by	ADP
ihlr-18810	292	17	manufacturers	manufacturer	NOUN
ihlr-18810	292	18	and	and	CCONJ
ihlr-18810	292	19	user	user	NOUN
ihlr-18810	292	20	facilities	facility	NOUN
ihlr-18810	292	21	as	as	ADV
ihlr-18810	292	22	well	well	ADV
ihlr-18810	292	23	as	as	ADP
ihlr-18810	292	24	third	third	ADJ
ihlr-18810	292	25	-	-	PUNCT
ihlr-18810	292	26	party	party	NOUN
ihlr-18810	292	27	safety	safety	NOUN
ihlr-18810	292	28	monitoring.100	monitoring.100	NOUN
ihlr-18810	292	29	reporting	report	VERB
ihlr-18810	292	30	includes	include	VERB
ihlr-18810	292	31	adverse	adverse	ADJ
ihlr-18810	292	32	-	-	PUNCT
ihlr-18810	292	33	event	event	NOUN
ihlr-18810	292	34	reporting	reporting	NOUN
ihlr-18810	292	35	of	of	ADP
ihlr-18810	292	36	incidents	incident	NOUN
ihlr-18810	292	37	resulting	result	VERB
ihlr-18810	292	38	in	in	ADP
ihlr-18810	292	39	serious	serious	ADJ
ihlr-18810	292	40	injury	injury	NOUN
ihlr-18810	292	41	or	or	CCONJ
ihlr-18810	292	42	death	death	NOUN
ihlr-18810	292	43	,	,	PUNCT
ihlr-18810	292	44	and	and	CCONJ
ihlr-18810	292	45	malfunction	malfunction	NOUN
ihlr-18810	292	46	reporting	report	VERB
ihlr-18810	292	47	after	after	SCONJ
ihlr-18810	292	48	a	a	DET
ihlr-18810	292	49	device	device	NOUN
ihlr-18810	292	50	fails	fail	VERB
ihlr-18810	292	51	without	without	ADP
ihlr-18810	292	52	causing	cause	VERB
ihlr-18810	292	53	an	an	DET
ihlr-18810	292	54	adverse	adverse	ADJ
ihlr-18810	292	55	event	event	NOUN
ihlr-18810	292	56	.	.	PUNCT
ihlr-18810	292	57	'	'	PUNCT
ihlr-18810	293	1	0	0	NUM
ihlr-18810	293	2	'	'	PUNCT
ihlr-18810	293	3	most	most	ADJ
ihlr-18810	293	4	of	of	ADP
ihlr-18810	293	5	this	this	DET
ihlr-18810	293	6	reporting	reporting	NOUN
ihlr-18810	293	7	is	be	AUX
ihlr-18810	293	8	done	do	VERB
ihlr-18810	293	9	by	by	ADP
ihlr-18810	293	10	manufacturers	manufacturer	NOUN
ihlr-18810	293	11	,	,	PUNCT
ihlr-18810	293	12	although	although	SCONJ
ihlr-18810	293	13	the	the	DET
ihlr-18810	293	14	safe	safe	ADJ
ihlr-18810	293	15	medical	medical	ADJ
ihlr-18810	293	16	devices	device	NOUN
ihlr-18810	293	17	amendments	amendment	NOUN
ihlr-18810	293	18	of	of	ADP
ihlr-18810	293	19	1990	1990	NUM
ihlr-18810	293	20	requires	require	VERB
ihlr-18810	293	21	healthcare	healthcare	NOUN
ihlr-18810	293	22	facilities	facility	NOUN
ihlr-18810	293	23	to	to	PART
ihlr-18810	293	24	report	report	VERB
ihlr-18810	293	25	device	device	NOUN
ihlr-18810	293	26	-	-	PUNCT
ihlr-18810	293	27	related	relate	VERB
ihlr-18810	293	28	death	death	NOUN
ihlr-18810	293	29	or	or	CCONJ
ihlr-18810	293	30	serious	serious	ADJ
ihlr-18810	293	31	injuries	injury	NOUN
ihlr-18810	293	32	to	to	ADP
ihlr-18810	293	33	the	the	DET
ihlr-18810	293	34	manufacturer.102	manufacturer.102	NOUN
ihlr-18810	293	35	generally	generally	ADV
ihlr-18810	293	36	,	,	PUNCT
ihlr-18810	293	37	patients	patient	NOUN
ihlr-18810	293	38	,	,	PUNCT
ihlr-18810	293	39	healthcare	healthcare	NOUN
ihlr-18810	293	40	professionals	professional	NOUN
ihlr-18810	293	41	,	,	PUNCT
ihlr-18810	293	42	and	and	CCONJ
ihlr-18810	293	43	caregivers	caregiver	NOUN
ihlr-18810	293	44	have	have	VERB
ihlr-18810	293	45	no	no	DET
ihlr-18810	293	46	legal	legal	ADJ
ihlr-18810	293	47	obligation	obligation	NOUN
ihlr-18810	293	48	to	to	PART
ihlr-18810	293	49	report	report	VERB
ihlr-18810	293	50	adverse	adverse	ADJ
ihlr-18810	293	51	medical	medical	ADJ
ihlr-18810	293	52	events	event	NOUN
ihlr-18810	293	53	;	;	PUNCT
ihlr-18810	293	54	however	however	ADV
ihlr-18810	293	55	,	,	PUNCT
ihlr-18810	293	56	they	they	PRON
ihlr-18810	293	57	can	can	AUX
ihlr-18810	293	58	provide	provide	VERB
ihlr-18810	293	59	voluntary	voluntary	ADJ
ihlr-18810	293	60	reports	report	NOUN
ihlr-18810	293	61	through	through	ADP
ihlr-18810	293	62	the	the	DET
ihlr-18810	293	63	fda	fda	PROPN
ihlr-18810	293	64	's	's	PART
ihlr-18810	293	65	medwatch	medwatch	ADJ
ihlr-18810	293	66	program.103	program.103	X
ihlr-18810	293	67	there	there	PRON
ihlr-18810	293	68	are	be	VERB
ihlr-18810	293	69	barriers	barrier	NOUN
ihlr-18810	293	70	to	to	ADP
ihlr-18810	293	71	the	the	DET
ihlr-18810	293	72	effectiveness	effectiveness	NOUN
ihlr-18810	293	73	of	of	ADP
ihlr-18810	293	74	these	these	DET
ihlr-18810	293	75	programs	program	NOUN
ihlr-18810	293	76	,	,	PUNCT
ihlr-18810	293	77	however	however	ADV
ihlr-18810	293	78	.	.	PUNCT
ihlr-18810	294	1	one	one	NUM
ihlr-18810	294	2	of	of	ADP
ihlr-18810	294	3	the	the	DET
ihlr-18810	294	4	fundamental	fundamental	ADJ
ihlr-18810	294	5	steps	step	NOUN
ihlr-18810	294	6	of	of	ADP
ihlr-18810	294	7	mdr	mdr	PROPN
ihlr-18810	294	8	is	be	AUX
ihlr-18810	294	9	,	,	PUNCT
ihlr-18810	294	10	after	after	ADP
ihlr-18810	294	11	recognizing	recognize	VERB
ihlr-18810	294	12	that	that	SCONJ
ihlr-18810	294	13	an	an	DET
ihlr-18810	294	14	adverse	adverse	ADJ
ihlr-18810	294	15	event	event	NOUN
ihlr-18810	294	16	has	have	AUX
ihlr-18810	294	17	occurred	occur	VERB
ihlr-18810	294	18	,	,	PUNCT
ihlr-18810	294	19	linking	link	VERB
ihlr-18810	294	20	that	that	DET
ihlr-18810	294	21	event	event	NOUN
ihlr-18810	294	22	with	with	ADP
ihlr-18810	294	23	one	one	NUM
ihlr-18810	294	24	or	or	CCONJ
ihlr-18810	294	25	more	more	ADV
ihlr-18810	294	26	possible	possible	ADJ
ihlr-18810	294	27	devices	device	NOUN
ihlr-18810	294	28	as	as	ADP
ihlr-18810	294	29	causal	causal	ADV
ihlr-18810	294	30	or	or	CCONJ
ihlr-18810	294	31	contributing	contribute	VERB
ihlr-18810	294	32	factors	factor	NOUN
ihlr-18810	294	33	.	.	PUNCT
ihlr-18810	295	1	104	104	NUM
ihlr-18810	295	2	it	it	PRON
ihlr-18810	295	3	can	can	AUX
ihlr-18810	295	4	be	be	AUX
ihlr-18810	295	5	difficult	difficult	ADJ
ihlr-18810	295	6	for	for	SCONJ
ihlr-18810	295	7	practitioners	practitioner	NOUN
ihlr-18810	295	8	to	to	PART
ihlr-18810	295	9	assess	assess	VERB
ihlr-18810	295	10	the	the	DET
ihlr-18810	295	11	role	role	NOUN
ihlr-18810	295	12	of	of	ADP
ihlr-18810	295	13	the	the	DET
ihlr-18810	295	14	device	device	NOUN
ihlr-18810	295	15	in	in	ADP
ihlr-18810	295	16	the	the	DET
ihlr-18810	295	17	patient	patient	NOUN
ihlr-18810	295	18	's	's	PART
ihlr-18810	295	19	unique	unique	ADJ
ihlr-18810	295	20	medical	medical	ADJ
ihlr-18810	295	21	problem	problem	NOUN
ihlr-18810	295	22	,	,	PUNCT
ihlr-18810	295	23	since	since	SCONJ
ihlr-18810	295	24	those	those	PRON
ihlr-18810	295	25	with	with	ADP
ihlr-18810	295	26	the	the	DET
ihlr-18810	295	27	relevant	relevant	ADJ
ihlr-18810	295	28	expertise	expertise	NOUN
ihlr-18810	295	29	may	may	AUX
ihlr-18810	295	30	not	not	PART
ihlr-18810	295	31	be	be	AUX
ihlr-18810	295	32	available	available	ADJ
ihlr-18810	295	33	to	to	PART
ihlr-18810	295	34	assist	assist	VERB
ihlr-18810	295	35	or	or	CCONJ
ihlr-18810	295	36	take	take	VERB
ihlr-18810	295	37	action	action	NOUN
ihlr-18810	295	38	at	at	ADP
ihlr-18810	295	39	the	the	DET
ihlr-18810	295	40	time	time	NOUN
ihlr-18810	295	41	the	the	DET
ihlr-18810	295	42	patient	patient	NOUN
ihlr-18810	295	43	presents	present	VERB
ihlr-18810	295	44	for	for	ADP
ihlr-18810	295	45	corrective	corrective	ADJ
ihlr-18810	295	46	action.105	action.105	NOUN
ihlr-18810	295	47	for	for	ADP
ihlr-18810	295	48	example	example	NOUN
ihlr-18810	295	49	,	,	PUNCT
ihlr-18810	295	50	it	it	PRON
ihlr-18810	295	51	may	may	AUX
ihlr-18810	295	52	be	be	AUX
ihlr-18810	295	53	easy	easy	ADJ
ihlr-18810	295	54	for	for	SCONJ
ihlr-18810	295	55	physicians	physician	NOUN
ihlr-18810	295	56	to	to	PART
ihlr-18810	295	57	notice	notice	VERB
ihlr-18810	295	58	unexpected	unexpected	ADJ
ihlr-18810	295	59	harms	harm	NOUN
ihlr-18810	295	60	resulting	result	VERB
ihlr-18810	295	61	from	from	ADP
ihlr-18810	295	62	the	the	DET
ihlr-18810	295	63	use	use	NOUN
ihlr-18810	295	64	of	of	ADP
ihlr-18810	295	65	a	a	DET
ihlr-18810	295	66	device	device	NOUN
ihlr-18810	295	67	,	,	PUNCT
ihlr-18810	295	68	but	but	CCONJ
ihlr-18810	295	69	they	they	PRON
ihlr-18810	295	70	are	be	AUX
ihlr-18810	295	71	less	less	ADV
ihlr-18810	295	72	likely	likely	ADJ
ihlr-18810	295	73	to	to	PART
ihlr-18810	295	74	detect	detect	VERB
ihlr-18810	295	75	an	an	DET
ihlr-18810	295	76	increased	increase	VERB
ihlr-18810	295	77	probability	probability	NOUN
ihlr-18810	295	78	of	of	ADP
ihlr-18810	295	79	familiar	familiar	ADJ
ihlr-18810	295	80	injuries	injury	NOUN
ihlr-18810	295	81	that	that	PRON
ihlr-18810	295	82	may	may	AUX
ihlr-18810	295	83	result	result	VERB
ihlr-18810	295	84	from	from	ADP
ihlr-18810	295	85	the	the	DET
ihlr-18810	295	86	device.106	device.106	NOUN
ihlr-18810	295	87	furthermore	furthermore	ADV
ihlr-18810	295	88	,	,	PUNCT
ihlr-18810	295	89	be	be	AUX
ihlr-18810	295	90	-	-	PUNCT
ihlr-18810	295	91	cause	cause	VERB
ihlr-18810	295	92	the	the	DET
ihlr-18810	295	93	onset	onset	NOUN
ihlr-18810	295	94	of	of	ADP
ihlr-18810	295	95	100	100	NUM
ihlr-18810	295	96	iom	iom	PROPN
ihlr-18810	295	97	report	report	NOUN
ihlr-18810	295	98	,	,	PUNCT
ihlr-18810	295	99	supra	supra	PROPN
ihlr-18810	295	100	note	note	NOUN
ihlr-18810	295	101	6	6	NUM
ihlr-18810	295	102	,	,	PUNCT
ihlr-18810	295	103	at	at	ADP
ihlr-18810	295	104	123	123	NUM
ihlr-18810	295	105	.	.	PUNCT
ihlr-18810	296	1	101	101	NUM
ihlr-18810	296	2	i	i	NOUN
ihlr-18810	296	3	d	d	PROPN
ihlr-18810	296	4	102	102	NUM
ihlr-18810	296	5	i	i	PRON
ihlr-18810	296	6	d.	d.	PROPN
ihlr-18810	296	7	at	at	ADP
ihlr-18810	296	8	124	124	NUM
ihlr-18810	296	9	-	-	SYM
ihlr-18810	296	10	25	25	NUM
ihlr-18810	296	11	.	.	PUNCT
ihlr-18810	296	12	103	103	NUM
ihlr-18810	296	13	see	see	VERB
ihlr-18810	296	14	i	i	PROPN
ihlr-18810	296	15	d.	d.	PROPN
ihlr-18810	296	16	at	at	ADP
ihlr-18810	296	17	124	124	NUM
ihlr-18810	296	18	;	;	PUNCT
ihlr-18810	296	19	safety	safety	NOUN
ihlr-18810	296	20	.	.	PUNCT
ihlr-18810	297	1	reporting	reporting	NOUN
ihlr-18810	297	2	by	by	ADP
ihlr-18810	297	3	consumers	consumer	NOUN
ihlr-18810	297	4	,	,	PUNCT
ihlr-18810	297	5	u.s	u.s	PROPN
ihlr-18810	297	6	.	.	PROPN
ihlr-18810	297	7	food	food	NOUN
ihlr-18810	297	8	and	and	CCONJ
ihlr-18810	297	9	drug	drug	NOUN
ihlr-18810	297	10	admin	admin	PROPN
ihlr-18810	297	11	.	.	PROPN
ihlr-18810	298	1	,	,	PUNCT
ihlr-18810	299	1	http://www.fda.gov/safety/medwatchlhowtoreport/	http://www.fda.gov/safety/medwatchlhowtoreport/	PROPN
ihlr-18810	299	2	ucm053074.htm	ucm053074.htm	PROPN
ihlr-18810	299	3	(	(	PUNCT
ihlr-18810	299	4	last	last	ADV
ihlr-18810	299	5	visited	visit	VERB
ihlr-18810	299	6	nov	nov	PROPN
ihlr-18810	299	7	.	.	PROPN
ihlr-18810	299	8	26	26	NUM
ihlr-18810	299	9	,	,	PUNCT
ihlr-18810	299	10	2012	2012	NUM
ihlr-18810	299	11	)	)	PUNCT
ihlr-18810	299	12	(	(	PUNCT
ihlr-18810	299	13	medwatch	medwatch	PROPN
ihlr-18810	299	14	is	be	AUX
ihlr-18810	299	15	the	the	DET
ihlr-18810	299	16	fda	fda	PROPN
ihlr-18810	299	17	's	's	PART
ihlr-18810	299	18	voluntary	voluntary	ADJ
ihlr-18810	299	19	reporting	reporting	NOUN
ihlr-18810	299	20	program	program	NOUN
ihlr-18810	299	21	for	for	ADP
ihlr-18810	299	22	the	the	DET
ihlr-18810	299	23	reporting	reporting	NOUN
ihlr-18810	299	24	of	of	ADP
ihlr-18810	299	25	serious	serious	ADJ
ihlr-18810	299	26	reactions	reaction	NOUN
ihlr-18810	299	27	,	,	PUNCT
ihlr-18810	299	28	product	product	NOUN
ihlr-18810	299	29	quality	quality	NOUN
ihlr-18810	299	30	problems	problem	NOUN
ihlr-18810	299	31	,	,	PUNCT
ihlr-18810	299	32	therapeutic	therapeutic	ADJ
ihlr-18810	299	33	inequivalence	inequivalence	NOUN
ihlr-18810	299	34	/	/	SYM
ihlr-18810	299	35	failure	failure	NOUN
ihlr-18810	299	36	,	,	PUNCT
ihlr-18810	299	37	and	and	CCONJ
ihlr-18810	299	38	product	product	NOUN
ihlr-18810	299	39	use	use	VERB
ihlr-18810	299	40	errors	error	NOUN
ihlr-18810	299	41	which	which	PRON
ihlr-18810	299	42	result	result	VERB
ihlr-18810	299	43	from	from	ADP
ihlr-18810	299	44	the	the	DET
ihlr-18810	299	45	use	use	NOUN
ihlr-18810	299	46	of	of	ADP
ihlr-18810	299	47	any	any	DET
ihlr-18810	299	48	human	human	ADJ
ihlr-18810	299	49	medical	medical	ADJ
ihlr-18810	299	50	products	product	NOUN
ihlr-18810	299	51	,	,	PUNCT
ihlr-18810	299	52	including	include	VERB
ihlr-18810	299	53	medical	medical	ADJ
ihlr-18810	299	54	devices	device	NOUN
ihlr-18810	299	55	.	.	PUNCT
ihlr-18810	299	56	)	)	PUNCT
ihlr-18810	299	57	.	.	PUNCT
ihlr-18810	300	1	104	104	NUM
ihlr-18810	301	1	i	i	PRON
ihlr-18810	301	2	d.	d.	PROPN
ihlr-18810	301	3	at	at	ADP
ihlr-18810	301	4	125	125	NUM
ihlr-18810	301	5	.	.	PUNCT
ihlr-18810	302	1	105	105	NUM
ihlr-18810	302	2	i	i	NOUN
ihlr-18810	302	3	d	d	PROPN
ihlr-18810	302	4	106	106	NUM
ihlr-18810	302	5	catherine	catherine	PROPN
ihlr-18810	302	6	t.	t.	PROPN
ihlr-18810	302	7	struve	struve	PROPN
ihlr-18810	302	8	,	,	PUNCT
ihlr-18810	302	9	the	the	DET
ihlr-18810	302	10	fda	fda	PROPN
ihlr-18810	302	11	and	and	CCONJ
ihlr-18810	302	12	the	the	DET
ihlr-18810	302	13	tort	tort	NOUN
ihlr-18810	302	14	system	system	NOUN
ihlr-18810	302	15	:	:	PUNCT
ihlr-18810	302	16	postmarketing	postmarkete	VERB
ihlr-18810	302	17	surveillance	surveillance	NOUN
ihlr-18810	302	18	,	,	PUNCT
ihlr-18810	302	19	compensation	compensation	NOUN
ihlr-18810	302	20	,	,	PUNCT
ihlr-18810	302	21	and	and	CCONJ
ihlr-18810	302	22	the	the	DET
ihlr-18810	302	23	role	role	NOUN
ihlr-18810	302	24	of	of	ADP
ihlr-18810	302	25	litigation	litigation	NOUN
ihlr-18810	302	26	,	,	PUNCT
ihlr-18810	302	27	2013	2013	NUM
ihlr-18810	302	28	135	135	NUM
ihlr-18810	302	29	indiana	indiana	PROPN
ihlr-18810	302	30	health	health	PROPN
ihlr-18810	302	31	law	law	PROPN
ihlr-18810	302	32	review	review	VERB
ihlr-18810	302	33	medical	medical	ADJ
ihlr-18810	302	34	problems	problem	NOUN
ihlr-18810	302	35	may	may	AUX
ihlr-18810	302	36	be	be	AUX
ihlr-18810	302	37	delayed	delay	VERB
ihlr-18810	302	38	,	,	PUNCT
ihlr-18810	302	39	patients	patient	NOUN
ihlr-18810	302	40	suffering	suffer	VERB
ihlr-18810	302	41	the	the	DET
ihlr-18810	302	42	effects	effect	NOUN
ihlr-18810	302	43	of	of	ADP
ihlr-18810	302	44	problematic	problematic	ADJ
ihlr-18810	302	45	devices	device	NOUN
ihlr-18810	302	46	may	may	AUX
ihlr-18810	302	47	no	no	ADV
ihlr-18810	302	48	longer	long	ADV
ihlr-18810	302	49	be	be	AUX
ihlr-18810	302	50	patients	patient	NOUN
ihlr-18810	302	51	of	of	ADP
ihlr-18810	302	52	the	the	DET
ihlr-18810	302	53	facility	facility	NOUN
ihlr-18810	302	54	which	which	PRON
ihlr-18810	302	55	used	use	VERB
ihlr-18810	302	56	the	the	DET
ihlr-18810	302	57	device	device	NOUN
ihlr-18810	302	58	in	in	ADP
ihlr-18810	302	59	the	the	DET
ihlr-18810	302	60	patient	patient	NOUN
ihlr-18810	302	61	's	's	PART
ihlr-18810	302	62	care	care	NOUN
ihlr-18810	302	63	,	,	PUNCT
ihlr-18810	302	64	the	the	DET
ihlr-18810	302	65	facility	facility	NOUN
ihlr-18810	302	66	with	with	ADP
ihlr-18810	302	67	an	an	DET
ihlr-18810	302	68	obligation	obligation	NOUN
ihlr-18810	302	69	to	to	PART
ihlr-18810	302	70	report	report	VERB
ihlr-18810	302	71	adverse	adverse	ADJ
ihlr-18810	302	72	events	event	NOUN
ihlr-18810	302	73	.	.	PUNCT
ihlr-18810	303	1	107	107	NUM
ihlr-18810	303	2	in	in	ADP
ihlr-18810	303	3	contrast	contrast	NOUN
ihlr-18810	303	4	,	,	PUNCT
ihlr-18810	303	5	the	the	DET
ihlr-18810	303	6	problems	problem	NOUN
ihlr-18810	303	7	arising	arise	VERB
ihlr-18810	303	8	from	from	ADP
ihlr-18810	303	9	the	the	DET
ihlr-18810	303	10	voluntary	voluntary	ADJ
ihlr-18810	303	11	reporting	reporting	NOUN
ihlr-18810	303	12	through	through	ADP
ihlr-18810	303	13	the	the	DET
ihlr-18810	303	14	medwatch	medwatch	ADJ
ihlr-18810	303	15	program	program	NOUN
ihlr-18810	303	16	may	may	AUX
ihlr-18810	303	17	result	result	VERB
ihlr-18810	303	18	from	from	ADP
ihlr-18810	303	19	over	over	ADP
ihlr-18810	303	20	reporting	reporting	NOUN
ihlr-18810	303	21	.	.	PUNCT
ihlr-18810	304	1	"	"	PUNCT
ihlr-18810	304	2	the	the	DET
ihlr-18810	304	3	medwatch	medwatch	ADJ
ihlr-18810	304	4	system	system	NOUN
ihlr-18810	304	5	generates	generate	VERB
ihlr-18810	304	6	some	some	DET
ihlr-18810	304	7	22,000	22,000	NUM
ihlr-18810	304	8	reports	report	NOUN
ihlr-18810	304	9	each	each	DET
ihlr-18810	304	10	year	year	NOUN
ihlr-18810	304	11	,	,	PUNCT
ihlr-18810	304	12	and	and	CCONJ
ihlr-18810	304	13	of	of	ADP
ihlr-18810	304	14	these	these	DET
ihlr-18810	304	15	a	a	DET
ihlr-18810	304	16	substantial	substantial	ADJ
ihlr-18810	304	17	number	number	NOUN
ihlr-18810	304	18	may	may	AUX
ihlr-18810	304	19	not	not	PART
ihlr-18810	304	20	involve	involve	VERB
ihlr-18810	304	21	a	a	DET
ihlr-18810	304	22	causal	causal	ADJ
ihlr-18810	304	23	link	link	NOUN
ihlr-18810	304	24	between	between	ADP
ihlr-18810	304	25	the	the	DET
ihlr-18810	304	26	product	product	NOUN
ihlr-18810	304	27	and	and	CCONJ
ihlr-18810	304	28	the	the	DET
ihlr-18810	304	29	injury	injury	NOUN
ihlr-18810	304	30	.	.	PUNCT
ihlr-18810	304	31	"	"	PUNCT
ihlr-18810	305	1	0	0	NUM
ihlr-18810	305	2	8	8	NUM
ihlr-18810	305	3	follow	follow	NOUN
ihlr-18810	305	4	-	-	PUNCT
ihlr-18810	305	5	up	up	ADP
ihlr-18810	305	6	inquiries	inquiry	NOUN
ihlr-18810	305	7	and	and	CCONJ
ihlr-18810	305	8	investigations	investigation	NOUN
ihlr-18810	305	9	performed	perform	VERB
ihlr-18810	305	10	by	by	ADP
ihlr-18810	305	11	the	the	DET
ihlr-18810	305	12	manufacturers	manufacturer	NOUN
ihlr-18810	305	13	are	be	AUX
ihlr-18810	305	14	important	important	ADJ
ihlr-18810	305	15	components	component	NOUN
ihlr-18810	305	16	of	of	ADP
ihlr-18810	305	17	the	the	DET
ihlr-18810	305	18	postmarket	postmarket	PROPN
ihlr-18810	305	19	surveillance	surveillance	NOUN
ihlr-18810	305	20	process	process	NOUN
ihlr-18810	305	21	.	.	PUNCT
ihlr-18810	306	1	the	the	DET
ihlr-18810	306	2	follow	follow	VERB
ihlr-18810	306	3	-	-	PUNCT
ihlr-18810	306	4	up	up	ADP
ihlr-18810	306	5	inquires	inquire	NOUN
ihlr-18810	306	6	,	,	PUNCT
ihlr-18810	306	7	which	which	PRON
ihlr-18810	306	8	are	be	AUX
ihlr-18810	306	9	required	require	VERB
ihlr-18810	306	10	by	by	ADP
ihlr-18810	306	11	the	the	DET
ihlr-18810	306	12	fda	fda	PROPN
ihlr-18810	306	13	for	for	ADP
ihlr-18810	306	14	the	the	DET
ihlr-18810	306	15	majority	majority	NOUN
ihlr-18810	306	16	of	of	ADP
ihlr-18810	306	17	reports	report	NOUN
ihlr-18810	306	18	received	receive	VERB
ihlr-18810	306	19	,	,	PUNCT
ihlr-18810	306	20	enable	enable	VERB
ihlr-18810	306	21	the	the	DET
ihlr-18810	306	22	manufacturer	manufacturer	NOUN
ihlr-18810	306	23	to	to	PART
ihlr-18810	306	24	fill	fill	VERB
ihlr-18810	306	25	in	in	ADP
ihlr-18810	306	26	the	the	DET
ihlr-18810	306	27	gaps	gap	NOUN
ihlr-18810	306	28	in	in	ADP
ihlr-18810	306	29	the	the	DET
ihlr-18810	306	30	information	information	NOUN
ihlr-18810	306	31	initially	initially	ADV
ihlr-18810	306	32	reported	report	VERB
ihlr-18810	306	33	109	109	NUM
ihlr-18810	306	34	and	and	CCONJ
ihlr-18810	306	35	en	en	NOUN
ihlr-18810	306	36	-	-	NOUN
ihlr-18810	306	37	able	able	ADJ
ihlr-18810	306	38	a	a	DET
ihlr-18810	306	39	better	well	ADJ
ihlr-18810	306	40	evaluation	evaluation	NOUN
ihlr-18810	306	41	and	and	CCONJ
ihlr-18810	306	42	assessment	assessment	NOUN
ihlr-18810	306	43	of	of	ADP
ihlr-18810	306	44	the	the	DET
ihlr-18810	306	45	device	device	NOUN
ihlr-18810	306	46	and	and	CCONJ
ihlr-18810	306	47	the	the	DET
ihlr-18810	306	48	event	event	NOUN
ihlr-18810	306	49	.	.	PUNCT
ihlr-18810	307	1	investigations	investigation	NOUN
ihlr-18810	307	2	work	work	VERB
ihlr-18810	307	3	to	to	PART
ihlr-18810	307	4	further	far	ADV
ihlr-18810	307	5	improve	improve	VERB
ihlr-18810	307	6	the	the	DET
ihlr-18810	307	7	information	information	NOUN
ihlr-18810	307	8	in	in	ADP
ihlr-18810	307	9	the	the	DET
ihlr-18810	307	10	mdr	mdr	NOUN
ihlr-18810	307	11	by	by	ADP
ihlr-18810	307	12	filling	fill	VERB
ihlr-18810	307	13	in	in	ADP
ihlr-18810	307	14	information	information	NOUN
ihlr-18810	307	15	gaps	gap	NOUN
ihlr-18810	307	16	that	that	PRON
ihlr-18810	307	17	may	may	AUX
ihlr-18810	307	18	exist	exist	VERB
ihlr-18810	307	19	.	.	PUNCT
ihlr-18810	308	1	however	however	ADV
ihlr-18810	308	2	,	,	PUNCT
ihlr-18810	308	3	investigations	investigation	NOUN
ihlr-18810	308	4	may	may	AUX
ihlr-18810	308	5	be	be	AUX
ihlr-18810	308	6	impeded	impede	VERB
ihlr-18810	308	7	by	by	ADP
ihlr-18810	308	8	the	the	DET
ihlr-18810	308	9	patient	patient	NOUN
ihlr-18810	308	10	,	,	PUNCT
ihlr-18810	308	11	treating	treat	VERB
ihlr-18810	308	12	physician	physician	NOUN
ihlr-18810	308	13	,	,	PUNCT
ihlr-18810	308	14	or	or	CCONJ
ihlr-18810	308	15	facility	facility	NOUN
ihlr-18810	308	16	refusals	refusal	NOUN
ihlr-18810	308	17	to	to	PART
ihlr-18810	308	18	provide	provide	VERB
ihlr-18810	308	19	additional	additional	ADJ
ihlr-18810	308	20	information.110	information.110	NOUN
ihlr-18810	308	21	additionally	additionally	ADV
ihlr-18810	308	22	,	,	PUNCT
ihlr-18810	308	23	because	because	SCONJ
ihlr-18810	308	24	physicians	physician	NOUN
ihlr-18810	308	25	and	and	CCONJ
ihlr-18810	308	26	healthcare	healthcare	PROPN
ihlr-18810	308	27	facilities	facility	NOUN
ihlr-18810	308	28	are	be	AUX
ihlr-18810	308	29	not	not	PART
ihlr-18810	308	30	reimbursed	reimburse	VERB
ihlr-18810	308	31	for	for	ADP
ihlr-18810	308	32	the	the	DET
ihlr-18810	308	33	time	time	NOUN
ihlr-18810	308	34	it	it	PRON
ihlr-18810	308	35	takes	take	VERB
ihlr-18810	308	36	to	to	PART
ihlr-18810	308	37	respond	respond	VERB
ihlr-18810	308	38	to	to	ADP
ihlr-18810	308	39	requests	request	NOUN
ihlr-18810	308	40	for	for	ADP
ihlr-18810	308	41	additional	additional	ADJ
ihlr-18810	308	42	information	information	NOUN
ihlr-18810	308	43	,	,	PUNCT
ihlr-18810	308	44	the	the	DET
ihlr-18810	308	45	efficacy	efficacy	NOUN
ihlr-18810	308	46	of	of	ADP
ihlr-18810	308	47	such	such	ADJ
ihlr-18810	308	48	follow	follow	NOUN
ihlr-18810	308	49	-	-	PUNCT
ihlr-18810	308	50	up	up	NOUN
ihlr-18810	308	51	may	may	AUX
ihlr-18810	308	52	be	be	AUX
ihlr-18810	308	53	impeded.11	impeded.11	VERB
ihlr-18810	308	54	'	'	PUNCT
ihlr-18810	308	55	once	once	SCONJ
ihlr-18810	308	56	the	the	DET
ihlr-18810	308	57	manufacturer	manufacturer	NOUN
ihlr-18810	308	58	has	have	AUX
ihlr-18810	308	59	obtained	obtain	VERB
ihlr-18810	308	60	all	all	DET
ihlr-18810	308	61	the	the	DET
ihlr-18810	308	62	information	information	NOUN
ihlr-18810	308	63	about	about	ADP
ihlr-18810	308	64	the	the	DET
ihlr-18810	308	65	event	event	NOUN
ihlr-18810	308	66	,	,	PUNCT
ihlr-18810	308	67	it	it	PRON
ihlr-18810	308	68	must	must	AUX
ihlr-18810	308	69	then	then	ADV
ihlr-18810	308	70	review	review	VERB
ihlr-18810	308	71	the	the	DET
ihlr-18810	308	72	record	record	NOUN
ihlr-18810	308	73	in	in	ADP
ihlr-18810	308	74	a	a	DET
ihlr-18810	308	75	timely	timely	ADJ
ihlr-18810	308	76	fashion	fashion	NOUN
ihlr-18810	308	77	and	and	CCONJ
ihlr-18810	308	78	determine	determine	VERB
ihlr-18810	308	79	whether	whether	SCONJ
ihlr-18810	308	80	the	the	DET
ihlr-18810	308	81	event	event	NOUN
ihlr-18810	308	82	meets	meet	VERB
ihlr-18810	308	83	the	the	DET
ihlr-18810	308	84	threshold	threshold	NOUN
ihlr-18810	308	85	for	for	SCONJ
ihlr-18810	308	86	a	a	DET
ihlr-18810	308	87	reportable	reportable	ADJ
ihlr-18810	308	88	event.112	event.112	NOUN
ihlr-18810	308	89	manufacturers	manufacturer	NOUN
ihlr-18810	308	90	have	have	VERB
ihlr-18810	308	91	thirty	thirty	NUM
ihlr-18810	308	92	days	day	NOUN
ihlr-18810	308	93	to	to	PART
ihlr-18810	308	94	report	report	VERB
ihlr-18810	308	95	if	if	SCONJ
ihlr-18810	308	96	a	a	DET
ihlr-18810	308	97	device	device	NOUN
ihlr-18810	308	98	may	may	AUX
ihlr-18810	308	99	have	have	AUX
ihlr-18810	308	100	caused	cause	VERB
ihlr-18810	308	101	or	or	CCONJ
ihlr-18810	308	102	contributed	contribute	VERB
ihlr-18810	308	103	to	to	ADP
ihlr-18810	308	104	a	a	DET
ihlr-18810	308	105	death	death	NOUN
ihlr-18810	308	106	or	or	CCONJ
ihlr-18810	308	107	serious	serious	ADJ
ihlr-18810	308	108	injury	injury	NOUN
ihlr-18810	308	109	,	,	PUNCT
ihlr-18810	308	110	or	or	CCONJ
ihlr-18810	308	111	if	if	SCONJ
ihlr-18810	308	112	death	death	NOUN
ihlr-18810	308	113	or	or	CCONJ
ihlr-18810	308	114	2	2	NUM
ihlr-18810	308	115	yale	yale	PROPN
ihlr-18810	308	116	j.	j.	PROPN
ihlr-18810	308	117	health	health	PROPN
ihlr-18810	308	118	pol'y	pol'y	PROPN
ihlr-18810	308	119	,	,	PUNCT
ihlr-18810	308	120	l.	l.	PROPN
ihlr-18810	308	121	&	&	CCONJ
ihlr-18810	308	122	ethics	ethic	NOUN
ihlr-18810	308	123	587	587	NUM
ihlr-18810	308	124	,	,	PUNCT
ihlr-18810	308	125	603	603	NUM
ihlr-18810	308	126	(	(	PUNCT
ihlr-18810	308	127	2005	2005	NUM
ihlr-18810	308	128	)	)	PUNCT
ihlr-18810	308	129	.	.	PUNCT
ihlr-18810	309	1	for	for	ADP
ihlr-18810	309	2	example	example	NOUN
ihlr-18810	309	3	,	,	PUNCT
ihlr-18810	309	4	it	it	PRON
ihlr-18810	309	5	may	may	AUX
ihlr-18810	309	6	not	not	PART
ihlr-18810	309	7	be	be	AUX
ihlr-18810	309	8	easy	easy	ADJ
ihlr-18810	309	9	for	for	SCONJ
ihlr-18810	309	10	healthcare	healthcare	NOUN
ihlr-18810	309	11	professionals	professional	NOUN
ihlr-18810	309	12	to	to	PART
ihlr-18810	309	13	determine	determine	VERB
ihlr-18810	309	14	whether	whether	SCONJ
ihlr-18810	309	15	a	a	DET
ihlr-18810	309	16	device	device	NOUN
ihlr-18810	309	17	may	may	AUX
ihlr-18810	309	18	cause	cause	VERB
ihlr-18810	309	19	or	or	CCONJ
ihlr-18810	309	20	increase	increase	VERB
ihlr-18810	309	21	the	the	DET
ihlr-18810	309	22	severity	severity	NOUN
ihlr-18810	309	23	of	of	ADP
ihlr-18810	309	24	a	a	DET
ihlr-18810	309	25	condition	condition	NOUN
ihlr-18810	309	26	that	that	PRON
ihlr-18810	309	27	is	be	AUX
ihlr-18810	309	28	relatively	relatively	ADV
ihlr-18810	309	29	common	common	ADJ
ihlr-18810	309	30	to	to	ADP
ihlr-18810	309	31	the	the	DET
ihlr-18810	309	32	control	control	NOUN
ihlr-18810	309	33	population	population	NOUN
ihlr-18810	309	34	considered	consider	VERB
ihlr-18810	309	35	.	.	PUNCT
ihlr-18810	310	1	i	i	PRON
ihlr-18810	310	2	d.	d.	PROPN
ihlr-18810	310	3	at	at	ADP
ihlr-18810	310	4	n.74	n.74	PROPN
ihlr-18810	310	5	.	.	PROPN
ihlr-18810	310	6	107	107	NUM
ihlr-18810	310	7	iom	iom	PROPN
ihlr-18810	310	8	report	report	NOUN
ihlr-18810	310	9	,	,	PUNCT
ihlr-18810	310	10	supra	supra	PROPN
ihlr-18810	310	11	note	note	NOUN
ihlr-18810	310	12	6	6	NUM
ihlr-18810	310	13	,	,	PUNCT
ihlr-18810	310	14	at	at	ADP
ihlr-18810	310	15	126	126	NUM
ihlr-18810	310	16	.	.	PUNCT
ihlr-18810	311	1	108	108	NUM
ihlr-18810	311	2	struve	struve	PROPN
ihlr-18810	311	3	,	,	PUNCT
ihlr-18810	311	4	supra	supra	PROPN
ihlr-18810	311	5	note	note	PROPN
ihlr-18810	311	6	106	106	NUM
ihlr-18810	311	7	,	,	PUNCT
ihlr-18810	311	8	at	at	ADP
ihlr-18810	311	9	604	604	NUM
ihlr-18810	311	10	.	.	PUNCT
ihlr-18810	311	11	109	109	NUM
ihlr-18810	311	12	iom	iom	PROPN
ihlr-18810	311	13	report	report	NOUN
ihlr-18810	311	14	,	,	PUNCT
ihlr-18810	311	15	supra	supra	PROPN
ihlr-18810	311	16	note	note	NOUN
ihlr-18810	311	17	6	6	NUM
ihlr-18810	311	18	,	,	PUNCT
ihlr-18810	311	19	at	at	ADP
ihlr-18810	311	20	126	126	NUM
ihlr-18810	311	21	.	.	PUNCT
ihlr-18810	312	1	110	110	NUM
ihlr-18810	313	1	i	i	NOUN
ihlr-18810	313	2	d	d	PROPN
ihlr-18810	313	3	111	111	NUM
ihlr-18810	314	1	i	i	PROPN
ihlr-18810	314	2	d	d	PROPN
ihlr-18810	314	3	112	112	NUM
ihlr-18810	314	4	i	i	NOUN
ihlr-18810	314	5	d	d	PROPN
ihlr-18810	314	6	136	136	NUM
ihlr-18810	314	7	vol	vol	NOUN
ihlr-18810	314	8	.	.	PUNCT
ihlr-18810	315	1	10	10	NUM
ihlr-18810	315	2	:	:	SYM
ihlr-18810	315	3	1	1	NUM
ihlr-18810	315	4	510(k	510(k	NUM
ihlr-18810	315	5	)	)	PUNCT
ihlr-18810	315	6	clearance	clearance	NOUN
ihlr-18810	315	7	serious	serious	ADJ
ihlr-18810	315	8	injury	injury	NOUN
ihlr-18810	315	9	could	could	AUX
ihlr-18810	315	10	result	result	VERB
ihlr-18810	315	11	if	if	SCONJ
ihlr-18810	315	12	the	the	DET
ihlr-18810	315	13	malfunction	malfunction	NOUN
ihlr-18810	315	14	reoccurs	reoccur	VERB
ihlr-18810	315	15	.	.	PUNCT
ihlr-18810	316	1	113	113	NUM
ihlr-18810	316	2	if	if	SCONJ
ihlr-18810	316	3	the	the	DET
ihlr-18810	316	4	reportable	reportable	ADJ
ihlr-18810	316	5	event	event	NOUN
ihlr-18810	316	6	requires	require	VERB
ihlr-18810	316	7	remedial	remedial	ADJ
ihlr-18810	316	8	action	action	NOUN
ihlr-18810	316	9	to	to	PART
ihlr-18810	316	10	prevent	prevent	VERB
ihlr-18810	316	11	a	a	DET
ihlr-18810	316	12	substantial	substantial	ADJ
ihlr-18810	316	13	risk	risk	NOUN
ihlr-18810	316	14	of	of	ADP
ihlr-18810	316	15	harm	harm	NOUN
ihlr-18810	316	16	to	to	ADP
ihlr-18810	316	17	public	public	ADJ
ihlr-18810	316	18	health	health	NOUN
ihlr-18810	316	19	,	,	PUNCT
ihlr-18810	316	20	the	the	DET
ihlr-18810	316	21	manufacturer	manufacturer	NOUN
ihlr-18810	316	22	must	must	AUX
ihlr-18810	316	23	report	report	VERB
ihlr-18810	316	24	within	within	ADP
ihlr-18810	316	25	five	five	NUM
ihlr-18810	316	26	days	day	NOUN
ihlr-18810	316	27	.	.	PUNCT
ihlr-18810	317	1	114	114	NUM
ihlr-18810	317	2	one	one	NUM
ihlr-18810	317	3	study	study	NOUN
ihlr-18810	317	4	found	find	VERB
ihlr-18810	317	5	that	that	SCONJ
ihlr-18810	317	6	,	,	PUNCT
ihlr-18810	317	7	in	in	ADP
ihlr-18810	317	8	2007	2007	NUM
ihlr-18810	317	9	,	,	PUNCT
ihlr-18810	317	10	31	31	NUM
ihlr-18810	317	11	%	%	NOUN
ihlr-18810	317	12	of	of	ADP
ihlr-18810	317	13	the	the	DET
ihlr-18810	317	14	critical	critical	ADJ
ihlr-18810	317	15	five	five	NUM
ihlr-18810	317	16	-	-	PUNCT
ihlr-18810	317	17	day	day	NOUN
ihlr-18810	317	18	reports	report	NOUN
ihlr-18810	317	19	were	be	AUX
ihlr-18810	317	20	submitted	submit	VERB
ihlr-18810	317	21	late	late	ADV
ihlr-18810	317	22	and	and	CCONJ
ihlr-18810	317	23	39	39	NUM
ihlr-18810	317	24	%	%	NOUN
ihlr-18810	317	25	of	of	ADP
ihlr-18810	317	26	the	the	DET
ihlr-18810	317	27	death	death	NOUN
ihlr-18810	317	28	and	and	CCONJ
ihlr-18810	317	29	injury	injury	NOUN
ihlr-18810	317	30	adverse	adverse	ADJ
ihlr-18810	317	31	-	-	PUNCT
ihlr-18810	317	32	event	event	NOUN
ihlr-18810	317	33	reports	report	NOUN
ihlr-18810	317	34	were	be	AUX
ihlr-18810	317	35	late.115	late.115	PROPN
ihlr-18810	317	36	"	"	PUNCT
ihlr-18810	317	37	the	the	DET
ihlr-18810	317	38	inadequacy	inadequacy	NOUN
ihlr-18810	317	39	of	of	ADP
ihlr-18810	317	40	the	the	DET
ihlr-18810	317	41	current	current	ADJ
ihlr-18810	317	42	postmarketing	postmarketing	NOUN
ihlr-18810	317	43	surveillance	surveillance	NOUN
ihlr-18810	317	44	system	system	NOUN
ihlr-18810	317	45	and	and	CCONJ
ihlr-18810	317	46	the	the	DET
ihlr-18810	317	47	resulting	result	VERB
ihlr-18810	317	48	lack	lack	NOUN
ihlr-18810	317	49	of	of	ADP
ihlr-18810	317	50	data	datum	NOUN
ihlr-18810	317	51	make	make	VERB
ihlr-18810	317	52	it	it	PRON
ihlr-18810	317	53	impossible	impossible	ADJ
ihlr-18810	317	54	to	to	PART
ihlr-18810	317	55	confidently	confidently	ADV
ihlr-18810	317	56	draw	draw	VERB
ihlr-18810	317	57	broad	broad	ADJ
ihlr-18810	317	58	conclusions	conclusion	NOUN
ihlr-18810	317	59	about	about	ADP
ihlr-18810	317	60	the	the	DET
ihlr-18810	317	61	safety	safety	NOUN
ihlr-18810	317	62	and	and	CCONJ
ihlr-18810	317	63	effectiveness	effectiveness	NOUN
ihlr-18810	317	64	of	of	ADP
ihlr-18810	317	65	products	product	NOUN
ihlr-18810	317	66	that	that	PRON
ihlr-18810	317	67	are	be	AUX
ihlr-18810	317	68	on	on	ADP
ihlr-18810	317	69	the	the	DET
ihlr-18810	317	70	market	market	NOUN
ihlr-18810	317	71	.	.	PUNCT
ihlr-18810	318	1	".116	".116	PUNCT
ihlr-18810	319	1	each	each	DET
ihlr-18810	319	2	mdr	mdr	PROPN
ihlr-18810	319	3	is	be	AUX
ihlr-18810	319	4	entered	enter	VERB
ihlr-18810	319	5	into	into	ADP
ihlr-18810	319	6	an	an	DET
ihlr-18810	319	7	fda	fda	PROPN
ihlr-18810	319	8	event	event	NOUN
ihlr-18810	319	9	database	database	NOUN
ihlr-18810	319	10	and	and	CCONJ
ihlr-18810	319	11	screened	screen	VERB
ihlr-18810	319	12	by	by	ADP
ihlr-18810	319	13	a	a	DET
ihlr-18810	319	14	safety	safety	NOUN
ihlr-18810	319	15	analyst	analyst	NOUN
ihlr-18810	319	16	,	,	PUNCT
ihlr-18810	319	17	"	"	PUNCT
ihlr-18810	319	18	generally	generally	ADV
ihlr-18810	319	19	a	a	DET
ihlr-18810	319	20	nurse	nurse	NOUN
ihlr-18810	319	21	or	or	CCONJ
ihlr-18810	319	22	engineer	engineer	NOUN
ihlr-18810	319	23	working	work	VERB
ihlr-18810	319	24	for	for	ADP
ihlr-18810	319	25	the	the	DET
ihlr-18810	319	26	fda	fda	PROPN
ihlr-18810	319	27	,	,	PUNCT
ihlr-18810	319	28	"	"	PUNCT
ihlr-18810	319	29	to	to	PART
ihlr-18810	319	30	identify	identify	VERB
ihlr-18810	319	31	a	a	DET
ihlr-18810	319	32	signal	signal	NOUN
ihlr-18810	319	33	of	of	ADP
ihlr-18810	319	34	risk	risk	NOUN
ihlr-18810	319	35	for	for	ADP
ihlr-18810	319	36	the	the	DET
ihlr-18810	319	37	potential	potential	ADJ
ihlr-18810	319	38	harm.117	harm.117	NOUN
ihlr-18810	319	39	this	this	DET
ihlr-18810	319	40	task	task	NOUN
ihlr-18810	319	41	is	be	AUX
ihlr-18810	319	42	not	not	PART
ihlr-18810	319	43	easily	easily	ADV
ihlr-18810	319	44	accomplished	accomplish	VERB
ihlr-18810	319	45	,	,	PUNCT
ihlr-18810	319	46	due	due	ADJ
ihlr-18810	319	47	in	in	ADP
ihlr-18810	319	48	part	part	NOUN
ihlr-18810	319	49	to	to	ADP
ihlr-18810	319	50	the	the	DET
ihlr-18810	319	51	limited	limited	ADJ
ihlr-18810	319	52	experience	experience	NOUN
ihlr-18810	319	53	of	of	ADP
ihlr-18810	319	54	the	the	DET
ihlr-18810	319	55	reviewer	reviewer	NOUN
ihlr-18810	319	56	with	with	ADP
ihlr-18810	319	57	the	the	DET
ihlr-18810	319	58	new	new	ADJ
ihlr-18810	319	59	device	device	NOUN
ihlr-18810	319	60	,	,	PUNCT
ihlr-18810	319	61	a	a	DET
ihlr-18810	319	62	lack	lack	NOUN
ihlr-18810	319	63	of	of	ADP
ihlr-18810	319	64	input	input	NOUN
ihlr-18810	319	65	by	by	ADP
ihlr-18810	319	66	the	the	DET
ihlr-18810	319	67	fda	fda	PROPN
ihlr-18810	319	68	's	's	PART
ihlr-18810	319	69	premarket	premarket	ADJ
ihlr-18810	319	70	staff	staff	NOUN
ihlr-18810	319	71	(	(	PUNCT
ihlr-18810	319	72	who	who	PRON
ihlr-18810	319	73	have	have	AUX
ihlr-18810	319	74	gained	gain	VERB
ihlr-18810	319	75	some	some	DET
ihlr-18810	319	76	familiarity	familiarity	NOUN
ihlr-18810	319	77	with	with	ADP
ihlr-18810	319	78	the	the	DET
ihlr-18810	319	79	device	device	NOUN
ihlr-18810	319	80	as	as	ADP
ihlr-18810	319	81	a	a	DET
ihlr-18810	319	82	result	result	NOUN
ihlr-18810	319	83	of	of	ADP
ihlr-18810	319	84	the	the	DET
ihlr-18810	319	85	premarket	premarket	NOUN
ihlr-18810	319	86	notification	notification	NOUN
ihlr-18810	319	87	process	process	NOUN
ihlr-18810	319	88	)	)	PUNCT
ihlr-18810	319	89	,	,	PUNCT
ihlr-18810	319	90	and	and	CCONJ
ihlr-18810	319	91	the	the	DET
ihlr-18810	319	92	large	large	ADJ
ihlr-18810	319	93	number	number	NOUN
ihlr-18810	319	94	of	of	ADP
ihlr-18810	319	95	reports	report	NOUN
ihlr-18810	319	96	each	each	DET
ihlr-18810	319	97	individual	individual	ADJ
ihlr-18810	319	98	analyst	analyst	NOUN
ihlr-18810	319	99	must	must	AUX
ihlr-18810	319	100	address.118	address.118	VERB
ihlr-18810	319	101	efforts	effort	NOUN
ihlr-18810	319	102	to	to	PART
ihlr-18810	319	103	reduce	reduce	VERB
ihlr-18810	319	104	the	the	DET
ihlr-18810	319	105	workload	workload	NOUN
ihlr-18810	319	106	of	of	ADP
ihlr-18810	319	107	the	the	DET
ihlr-18810	319	108	safety	safety	NOUN
ihlr-18810	319	109	analysts	analyst	NOUN
ihlr-18810	319	110	and	and	CCONJ
ihlr-18810	319	111	to	to	PART
ihlr-18810	319	112	open	open	VERB
ihlr-18810	319	113	communication	communication	NOUN
ihlr-18810	319	114	between	between	ADP
ihlr-18810	319	115	premarket	premarket	NOUN
ihlr-18810	319	116	staff	staff	NOUN
ihlr-18810	319	117	and	and	CCONJ
ihlr-18810	319	118	report	report	NOUN
ihlr-18810	319	119	screening	screen	VERB
ihlr-18810	319	120	staff	staff	NOUN
ihlr-18810	319	121	have	have	AUX
ihlr-18810	319	122	been	be	AUX
ihlr-18810	319	123	thwarted	thwart	VERB
ihlr-18810	319	124	by	by	ADP
ihlr-18810	319	125	logistical	logistical	ADJ
ihlr-18810	319	126	problems	problem	NOUN
ihlr-18810	319	127	arising	arise	VERB
ihlr-18810	319	128	from	from	ADP
ihlr-18810	319	129	the	the	DET
ihlr-18810	319	130	fda	fda	PROPN
ihlr-18810	319	131	's	's	PART
ihlr-18810	319	132	limited	limited	ADJ
ihlr-18810	319	133	resources	resource	NOUN
ihlr-18810	319	134	,	,	PUNCT
ihlr-18810	319	135	the	the	DET
ihlr-18810	319	136	differing	differ	VERB
ihlr-18810	319	137	physical	physical	ADJ
ihlr-18810	319	138	locations	location	NOUN
ihlr-18810	319	139	of	of	ADP
ihlr-18810	319	140	the	the	DET
ihlr-18810	319	141	staff	staff	NOUN
ihlr-18810	319	142	,	,	PUNCT
ihlr-18810	319	143	and	and	CCONJ
ihlr-18810	319	144	the	the	DET
ihlr-18810	319	145	heavy	heavy	ADJ
ihlr-18810	319	146	workload	workload	NOUN
ihlr-18810	319	147	of	of	ADP
ihlr-18810	319	148	all	all	DET
ihlr-18810	319	149	fda	fda	PROPN
ihlr-18810	319	150	employees	employee	NOUN
ihlr-18810	319	151	.	.	PUNCT
ihlr-18810	319	152	"	"	PUNCT
ihlr-18810	320	1	9	9	NUM
ihlr-18810	320	2	when	when	SCONJ
ihlr-18810	320	3	signals	signal	NOUN
ihlr-18810	320	4	are	be	AUX
ihlr-18810	320	5	found	find	VERB
ihlr-18810	320	6	,	,	PUNCT
ihlr-18810	320	7	they	they	PRON
ihlr-18810	320	8	are	be	AUX
ihlr-18810	320	9	entered	enter	VERB
ihlr-18810	320	10	into	into	ADP
ihlr-18810	320	11	the	the	DET
ihlr-18810	320	12	cdrh	cdrh	NOUN
ihlr-18810	320	13	database	database	NOUN
ihlr-18810	320	14	,	,	PUNCT
ihlr-18810	320	15	which	which	PRON
ihlr-18810	320	16	includes	include	VERB
ihlr-18810	320	17	information	information	NOUN
ihlr-18810	320	18	about	about	ADP
ihlr-18810	320	19	medical	medical	ADJ
ihlr-18810	320	20	device	device	NOUN
ihlr-18810	320	21	malfunctions	malfunction	NOUN
ihlr-18810	320	22	as	as	ADV
ihlr-18810	320	23	well	well	ADV
ihlr-18810	320	24	as	as	ADP
ihlr-18810	320	25	foreign	foreign	ADJ
ihlr-18810	320	26	inspections	inspection	NOUN
ihlr-18810	320	27	and	and	CCONJ
ihlr-18810	320	28	labeling	labeling	NOUN
ihlr-18810	320	29	and	and	CCONJ
ihlr-18810	320	30	software	software	NOUN
ihlr-18810	320	31	issues.120	issues.120	PROPN
ihlr-18810	320	32	the	the	DET
ihlr-18810	320	33	113	113	NUM
ihlr-18810	320	34	i	i	PRON
ihlr-18810	320	35	d.	d.	PROPN
ihlr-18810	320	36	at	at	ADP
ihlr-18810	320	37	127	127	NUM
ihlr-18810	320	38	.	.	PUNCT
ihlr-18810	321	1	114	114	NUM
ihlr-18810	322	1	i	i	PROPN
ihlr-18810	322	2	d.	d.	PROPN
ihlr-18810	322	3	115	115	PROPN
ihlr-18810	323	1	i	i	PRON
ihlr-18810	323	2	d.	d.	PROPN
ihlr-18810	323	3	116	116	NUM
ihlr-18810	324	1	i	i	PRON
ihlr-18810	324	2	d.	d.	PROPN
ihlr-18810	324	3	at	at	ADP
ihlr-18810	324	4	129	129	NUM
ihlr-18810	324	5	.	.	PUNCT
ihlr-18810	325	1	117	117	NUM
ihlr-18810	326	1	i	i	PROPN
ihlr-18810	326	2	d.	d.	PROPN
ihlr-18810	326	3	at	at	ADP
ihlr-18810	326	4	127	127	NUM
ihlr-18810	326	5	.	.	PUNCT
ihlr-18810	327	1	118	118	NUM
ihlr-18810	328	1	i	i	NOUN
ihlr-18810	328	2	d.	d.	PROPN
ihlr-18810	328	3	119	119	NUM
ihlr-18810	329	1	i	i	PRON
ihlr-18810	329	2	d.	d.	PROPN
ihlr-18810	329	3	at	at	ADP
ihlr-18810	329	4	127	127	NUM
ihlr-18810	329	5	-	-	SYM
ihlr-18810	329	6	28	28	NUM
ihlr-18810	329	7	.	.	PUNCT
ihlr-18810	330	1	120	120	NUM
ihlr-18810	330	2	cdrh	cdrh	NOUN
ihlr-18810	330	3	inspections	inspection	NOUN
ihlr-18810	330	4	database	database	NOUN
ihlr-18810	330	5	,	,	PUNCT
ihlr-18810	330	6	fda.gov	fda.gov	NUM
ihlr-18810	330	7	,	,	PUNCT
ihlr-18810	330	8	http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproducts	http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproduct	NOUN
ihlr-18810	330	9	andtobaccolcdrh	andtobaccolcdrh	ADJ
ihlr-18810	330	10	/	/	SYM
ihlr-18810	330	11	cdrhtransparency	cdrhtransparency	NOUN
ihlr-18810	330	12	/	/	SYM
ihlr-18810	330	13	ucm223770.htm	ucm223770.htm	PROPN
ihlr-18810	330	14	(	(	PUNCT
ihlr-18810	330	15	last	last	ADV
ihlr-18810	330	16	visited	visit	VERB
ihlr-18810	330	17	nov	nov	PROPN
ihlr-18810	330	18	.	.	PROPN
ihlr-18810	330	19	27	27	NUM
ihlr-18810	330	20	,	,	PUNCT
ihlr-18810	330	21	2012	2012	NUM
ihlr-18810	330	22	)	)	PUNCT
ihlr-18810	330	23	.	.	PUNCT
ihlr-18810	331	1	this	this	DET
ihlr-18810	331	2	database	database	NOUN
ihlr-18810	331	3	contains	contain	VERB
ihlr-18810	331	4	only	only	ADJ
ihlr-18810	331	5	information	information	NOUN
ihlr-18810	331	6	from	from	ADP
ihlr-18810	331	7	inspections	inspection	NOUN
ihlr-18810	331	8	which	which	PRON
ihlr-18810	331	9	were	be	AUX
ihlr-18810	331	10	the	the	DET
ihlr-18810	331	11	cdrh	cdrh	NOUN
ihlr-18810	331	12	's	's	PART
ihlr-18810	331	13	respon	respon	NOUN
ihlr-18810	331	14	-	-	PUNCT
ihlr-18810	331	15	sibility	sibility	NOUN
ihlr-18810	331	16	,	,	PUNCT
ihlr-18810	331	17	about	about	ADV
ihlr-18810	331	18	25	25	NUM
ihlr-18810	331	19	%	%	NOUN
ihlr-18810	331	20	of	of	ADP
ihlr-18810	331	21	the	the	DET
ihlr-18810	331	22	total	total	ADJ
ihlr-18810	331	23	device	device	NOUN
ihlr-18810	331	24	inspections	inspection	NOUN
ihlr-18810	331	25	,	,	PUNCT
ihlr-18810	331	26	and	and	CCONJ
ihlr-18810	331	27	have	have	AUX
ihlr-18810	331	28	been	be	AUX
ihlr-18810	331	29	conducted	conduct	VERB
ihlr-18810	331	30	since	since	SCONJ
ihlr-18810	331	31	2008	2008	NUM
ihlr-18810	331	32	.	.	PUNCT
ihlr-18810	332	1	2013	2013	NUM
ihlr-18810	332	2	137	137	NUM
ihlr-18810	332	3	indiana	indiana	PROPN
ihlr-18810	332	4	health	health	PROPN
ihlr-18810	332	5	law	law	NOUN
ihlr-18810	332	6	review	review	VERB
ihlr-18810	332	7	primary	primary	ADJ
ihlr-18810	332	8	repository	repository	NOUN
ihlr-18810	332	9	for	for	ADP
ihlr-18810	332	10	adverse	adverse	ADJ
ihlr-18810	332	11	event	event	NOUN
ihlr-18810	332	12	reports	report	NOUN
ihlr-18810	332	13	remains	remain	VERB
ihlr-18810	332	14	the	the	DET
ihlr-18810	332	15	manufacturer	manufacturer	NOUN
ihlr-18810	332	16	and	and	CCONJ
ihlr-18810	332	17	user	user	NOUN
ihlr-18810	332	18	facility	facility	NOUN
ihlr-18810	332	19	device	device	NOUN
ihlr-18810	332	20	experience	experience	NOUN
ihlr-18810	332	21	database	database	NOUN
ihlr-18810	332	22	,	,	PUNCT
ihlr-18810	332	23	which	which	PRON
ihlr-18810	332	24	is	be	AUX
ihlr-18810	332	25	specific	specific	ADJ
ihlr-18810	332	26	to	to	ADP
ihlr-18810	332	27	medical	medical	ADJ
ihlr-18810	332	28	device	device	NOUN
ihlr-18810	332	29	malfunctions	malfunction	NOUN
ihlr-18810	332	30	and	and	CCONJ
ihlr-18810	332	31	adverse	adverse	ADJ
ihlr-18810	332	32	events.121	events.121	ADV
ihlr-18810	332	33	however	however	ADV
ihlr-18810	332	34	,	,	PUNCT
ihlr-18810	332	35	this	this	DET
ihlr-18810	332	36	database	database	NOUN
ihlr-18810	332	37	is	be	AUX
ihlr-18810	332	38	difficult	difficult	ADJ
ihlr-18810	332	39	to	to	PART
ihlr-18810	332	40	use	use	VERB
ihlr-18810	332	41	because	because	SCONJ
ihlr-18810	332	42	it	it	PRON
ihlr-18810	332	43	does	do	AUX
ihlr-18810	332	44	not	not	PART
ihlr-18810	332	45	incorporate	incorporate	VERB
ihlr-18810	332	46	relevant	relevant	ADJ
ihlr-18810	332	47	information	information	NOUN
ihlr-18810	332	48	from	from	ADP
ihlr-18810	332	49	other	other	ADJ
ihlr-18810	332	50	fda	fda	PROPN
ihlr-18810	332	51	databases	database	NOUN
ihlr-18810	332	52	,	,	PUNCT
ihlr-18810	332	53	such	such	ADJ
ihlr-18810	332	54	as	as	ADP
ihlr-18810	332	55	the	the	DET
ihlr-18810	332	56	cdrh	cdrh	NOUN
ihlr-18810	332	57	database	database	NOUN
ihlr-18810	332	58	,	,	PUNCT
ihlr-18810	332	59	and	and	CCONJ
ihlr-18810	332	60	many	many	ADJ
ihlr-18810	332	61	of	of	ADP
ihlr-18810	332	62	the	the	DET
ihlr-18810	332	63	entries	entry	NOUN
ihlr-18810	332	64	are	be	AUX
ihlr-18810	332	65	incomplete	incomplete	ADJ
ihlr-18810	332	66	or	or	CCONJ
ihlr-18810	332	67	misclassified.122	misclassified.122	PRON
ihlr-18810	332	68	the	the	DET
ihlr-18810	332	69	different	different	ADJ
ihlr-18810	332	70	databases	database	NOUN
ihlr-18810	332	71	were	be	AUX
ihlr-18810	332	72	created	create	VERB
ihlr-18810	332	73	at	at	ADP
ihlr-18810	332	74	different	different	ADJ
ihlr-18810	332	75	times	time	NOUN
ihlr-18810	332	76	to	to	PART
ihlr-18810	332	77	serve	serve	VERB
ihlr-18810	332	78	different	different	ADJ
ihlr-18810	332	79	purposes	purpose	NOUN
ihlr-18810	332	80	,	,	PUNCT
ihlr-18810	332	81	and	and	CCONJ
ihlr-18810	332	82	although	although	SCONJ
ihlr-18810	332	83	they	they	PRON
ihlr-18810	332	84	share	share	VERB
ihlr-18810	332	85	information	information	NOUN
ihlr-18810	332	86	relevant	relevant	ADJ
ihlr-18810	332	87	to	to	ADP
ihlr-18810	332	88	each	each	DET
ihlr-18810	332	89	other	other	ADJ
ihlr-18810	332	90	,	,	PUNCT
ihlr-18810	332	91	the	the	DET
ihlr-18810	332	92	databases	database	NOUN
ihlr-18810	332	93	have	have	AUX
ihlr-18810	332	94	not	not	PART
ihlr-18810	332	95	yet	yet	ADV
ihlr-18810	332	96	been	be	AUX
ihlr-18810	332	97	incorporated	incorporate	VERB
ihlr-18810	332	98	into	into	ADP
ihlr-18810	332	99	a	a	DET
ihlr-18810	332	100	single	single	ADJ
ihlr-18810	332	101	information	information	NOUN
ihlr-18810	332	102	source	source	NOUN
ihlr-18810	332	103	.	.	PUNCT
ihlr-18810	333	1	in	in	ADP
ihlr-18810	333	2	addition	addition	NOUN
ihlr-18810	333	3	to	to	ADP
ihlr-18810	333	4	reporting	reporting	NOUN
ihlr-18810	333	5	,	,	PUNCT
ihlr-18810	333	6	the	the	DET
ihlr-18810	333	7	fda	fda	PROPN
ihlr-18810	333	8	conducts	conduct	VERB
ihlr-18810	333	9	postmarket	postmarket	ADJ
ihlr-18810	333	10	surveillance	surveillance	NOUN
ihlr-18810	333	11	of	of	ADP
ihlr-18810	333	12	devices	device	NOUN
ihlr-18810	333	13	through	through	ADP
ihlr-18810	333	14	a	a	DET
ihlr-18810	333	15	number	number	NOUN
ihlr-18810	333	16	of	of	ADP
ihlr-18810	333	17	other	other	ADJ
ihlr-18810	333	18	mechanisms	mechanism	NOUN
ihlr-18810	333	19	.	.	PUNCT
ihlr-18810	334	1	the	the	DET
ihlr-18810	334	2	fda	fda	PROPN
ihlr-18810	334	3	can	can	AUX
ihlr-18810	334	4	issue	issue	VERB
ihlr-18810	334	5	orders	order	NOUN
ihlr-18810	334	6	requiring	require	VERB
ihlr-18810	334	7	manufacturers	manufacturer	NOUN
ihlr-18810	334	8	to	to	PART
ihlr-18810	334	9	track	track	VERB
ihlr-18810	334	10	certain	certain	ADJ
ihlr-18810	334	11	types	type	NOUN
ihlr-18810	334	12	of	of	ADP
ihlr-18810	334	13	devices	device	NOUN
ihlr-18810	334	14	through	through	ADP
ihlr-18810	334	15	the	the	DET
ihlr-18810	334	16	distribution	distribution	NOUN
ihlr-18810	334	17	chain.123	chain.123	NOUN
ihlr-18810	334	18	this	this	PRON
ihlr-18810	334	19	is	be	AUX
ihlr-18810	334	20	done	do	VERB
ihlr-18810	334	21	to	to	PART
ihlr-18810	334	22	ensure	ensure	VERB
ihlr-18810	334	23	that	that	SCONJ
ihlr-18810	334	24	manufacturers	manufacturer	NOUN
ihlr-18810	334	25	are	be	AUX
ihlr-18810	334	26	able	able	ADJ
ihlr-18810	334	27	to	to	PART
ihlr-18810	334	28	promptly	promptly	ADV
ihlr-18810	334	29	locate	locate	VERB
ihlr-18810	334	30	the	the	DET
ihlr-18810	334	31	devices	device	NOUN
ihlr-18810	334	32	in	in	ADP
ihlr-18810	334	33	commercial	commercial	ADJ
ihlr-18810	334	34	distribution	distribution	NOUN
ihlr-18810	334	35	which	which	PRON
ihlr-18810	334	36	,	,	PUNCT
ihlr-18810	334	37	in	in	ADP
ihlr-18810	334	38	the	the	DET
ihlr-18810	334	39	event	event	NOUN
ihlr-18810	334	40	serious	serious	ADJ
ihlr-18810	334	41	health	health	NOUN
ihlr-18810	334	42	risks	risk	NOUN
ihlr-18810	334	43	are	be	AUX
ihlr-18810	334	44	presented	present	VERB
ihlr-18810	334	45	by	by	ADP
ihlr-18810	334	46	the	the	DET
ihlr-18810	334	47	devices	device	NOUN
ihlr-18810	334	48	,	,	PUNCT
ihlr-18810	334	49	will	will	AUX
ihlr-18810	334	50	facilitate	facilitate	VERB
ihlr-18810	334	51	notifications	notification	NOUN
ihlr-18810	334	52	and	and	CCONJ
ihlr-18810	334	53	recalls	recall	VERB
ihlr-18810	334	54	the	the	DET
ihlr-18810	334	55	fda	fda	PROPN
ihlr-18810	334	56	may	may	AUX
ihlr-18810	334	57	order.124	order.124	PROPN
ihlr-18810	334	58	manufacturers	manufacturer	NOUN
ihlr-18810	334	59	are	be	AUX
ihlr-18810	334	60	expected	expect	VERB
ihlr-18810	334	61	to	to	PART
ihlr-18810	334	62	have	have	VERB
ihlr-18810	334	63	the	the	DET
ihlr-18810	334	64	ability	ability	NOUN
ihlr-18810	334	65	to	to	PART
ihlr-18810	334	66	promptly	promptly	ADV
ihlr-18810	334	67	provide	provide	VERB
ihlr-18810	334	68	information	information	NOUN
ihlr-18810	334	69	about	about	ADP
ihlr-18810	334	70	the	the	DET
ihlr-18810	334	71	location	location	NOUN
ihlr-18810	334	72	of	of	ADP
ihlr-18810	334	73	devices	device	NOUN
ihlr-18810	334	74	already	already	ADV
ihlr-18810	334	75	distributed	distribute	VERB
ihlr-18810	334	76	to	to	ADP
ihlr-18810	334	77	patients	patient	NOUN
ihlr-18810	334	78	and	and	CCONJ
ihlr-18810	334	79	the	the	DET
ihlr-18810	334	80	devices	device	NOUN
ihlr-18810	334	81	in	in	ADP
ihlr-18810	334	82	the	the	DET
ihlr-18810	334	83	manufacturer	manufacturer	NOUN
ihlr-18810	334	84	's	's	PART
ihlr-18810	334	85	or	or	CCONJ
ihlr-18810	334	86	distributor	distributor	NOUN
ihlr-18810	334	87	's	's	PART
ihlr-18810	334	88	inventory.125	inventory.125	VERB
ihlr-18810	334	89	to	to	PART
ihlr-18810	334	90	improve	improve	VERB
ihlr-18810	334	91	the	the	DET
ihlr-18810	334	92	fda	fda	PROPN
ihlr-18810	334	93	's	's	PART
ihlr-18810	334	94	tracking	tracking	NOUN
ihlr-18810	334	95	efforts	effort	NOUN
ihlr-18810	334	96	,	,	PUNCT
ihlr-18810	334	97	the	the	DET
ihlr-18810	334	98	fda	fda	PROPN
ihlr-18810	334	99	amendments	amendment	NOUN
ihlr-18810	334	100	act	act	AUX
ihlr-18810	334	101	called	call	VERB
ihlr-18810	334	102	for	for	SCONJ
ihlr-18810	334	103	the	the	DET
ihlr-18810	334	104	fda	fda	PROPN
ihlr-18810	334	105	to	to	PART
ihlr-18810	334	106	develop	develop	VERB
ihlr-18810	334	107	a	a	DET
ihlr-18810	334	108	unique	unique	ADJ
ihlr-18810	334	109	device	device	NOUN
ihlr-18810	334	110	identification	identification	NOUN
ihlr-18810	334	111	(	(	PUNCT
ihlr-18810	334	112	udi	udi	PROPN
ihlr-18810	334	113	)	)	PUNCT
ihlr-18810	334	114	121	121	NUM
ihlr-18810	334	115	iom	iom	PROPN
ihlr-18810	334	116	report	report	NOUN
ihlr-18810	334	117	,	,	PUNCT
ihlr-18810	334	118	supra	supra	PROPN
ihlr-18810	334	119	note	note	NOUN
ihlr-18810	334	120	6	6	NUM
ihlr-18810	334	121	,	,	PUNCT
ihlr-18810	334	122	at	at	ADP
ihlr-18810	334	123	128	128	NUM
ihlr-18810	334	124	;	;	PUNCT
ihlr-18810	334	125	see	see	VERB
ihlr-18810	334	126	also	also	ADV
ihlr-18810	334	127	manufacturer	manufacturer	NOUN
ihlr-18810	334	128	and	and	CCONJ
ihlr-18810	334	129	user	user	NOUN
ihlr-18810	334	130	facility	facility	NOUN
ihlr-18810	334	131	device	device	NOUN
ihlr-18810	334	132	experience	experience	NOUN
ihlr-18810	334	133	database	database	NOUN
ihlr-18810	334	134	(	(	PUNCT
ihlr-18810	334	135	maude	maude	PROPN
ihlr-18810	334	136	)	)	PUNCT
ihlr-18810	334	137	,	,	PUNCT
ihlr-18810	334	138	fda.gov	fda.gov	NUM
ihlr-18810	334	139	,	,	PUNCT
ihlr-18810	334	140	http://www.fda.gov/medicaldevices/deviceregulationandguidancel	http://www.fda.gov/medicaldevices/deviceregulationandguidancel	PROPN
ihlr-18810	334	141	postmarketrequirements	postmarketrequirement	NOUN
ihlr-18810	334	142	/	/	SYM
ihlr-18810	334	143	reportingadverseevents	reportingadverseevent	NOUN
ihlr-18810	334	144	/	/	SYM
ihlr-18810	334	145	ucml27891.htm	ucml27891.htm	NOUN
ihlr-18810	334	146	(	(	PUNCT
ihlr-18810	334	147	last	last	ADV
ihlr-18810	334	148	visited	visit	VERB
ihlr-18810	334	149	nov	nov	PROPN
ihlr-18810	334	150	.	.	PROPN
ihlr-18810	334	151	27	27	NUM
ihlr-18810	334	152	,	,	PUNCT
ihlr-18810	334	153	2012	2012	NUM
ihlr-18810	334	154	)	)	PUNCT
ihlr-18810	334	155	(	(	PUNCT
ihlr-18810	334	156	"	"	PUNCT
ihlr-18810	334	157	maude	maude	PROPN
ihlr-18810	334	158	data	datum	NOUN
ihlr-18810	334	159	represents	represent	VERB
ihlr-18810	334	160	reports	report	NOUN
ihlr-18810	334	161	of	of	ADP
ihlr-18810	334	162	adverse	adverse	ADJ
ihlr-18810	334	163	events	event	NOUN
ihlr-18810	334	164	involving	involve	VERB
ihlr-18810	334	165	medical	medical	ADJ
ihlr-18810	334	166	devices	device	NOUN
ihlr-18810	334	167	.	.	PUNCT
ihlr-18810	335	1	the	the	DET
ihlr-18810	335	2	data	data	NOUN
ihlr-18810	335	3	consists	consist	VERB
ihlr-18810	335	4	of	of	ADP
ihlr-18810	335	5	voluntary	voluntary	ADJ
ihlr-18810	335	6	reports	report	NOUN
ihlr-18810	335	7	since	since	SCONJ
ihlr-18810	335	8	june	june	PROPN
ihlr-18810	335	9	1993	1993	NUM
ihlr-18810	335	10	,	,	PUNCT
ihlr-18810	335	11	user	user	NOUN
ihlr-18810	335	12	facility	facility	NOUN
ihlr-18810	335	13	reports	report	NOUN
ihlr-18810	335	14	since	since	SCONJ
ihlr-18810	335	15	1991	1991	NUM
ihlr-18810	335	16	,	,	PUNCT
ihlr-18810	335	17	distributor	distributor	NOUN
ihlr-18810	335	18	reports	report	NOUN
ihlr-18810	335	19	since	since	SCONJ
ihlr-18810	335	20	1993	1993	NUM
ihlr-18810	335	21	,	,	PUNCT
ihlr-18810	335	22	and	and	CCONJ
ihlr-18810	335	23	manufacturer	manufacturer	NOUN
ihlr-18810	335	24	reports	report	NOUN
ihlr-18810	335	25	since	since	SCONJ
ihlr-18810	335	26	august	august	PROPN
ihlr-18810	335	27	1996	1996	NUM
ihlr-18810	335	28	.	.	PUNCT
ihlr-18810	336	1	"	"	PUNCT
ihlr-18810	336	2	)	)	PUNCT
ihlr-18810	336	3	.	.	PUNCT
ihlr-18810	337	1	122	122	NUM
ihlr-18810	337	2	iom	iom	PROPN
ihlr-18810	337	3	report	report	NOUN
ihlr-18810	337	4	,	,	PUNCT
ihlr-18810	337	5	supra	supra	PROPN
ihlr-18810	337	6	note	note	NOUN
ihlr-18810	337	7	6	6	NUM
ihlr-18810	337	8	,	,	PUNCT
ihlr-18810	337	9	at	at	ADP
ihlr-18810	337	10	128	128	NUM
ihlr-18810	337	11	.	.	PUNCT
ihlr-18810	337	12	123	123	NUM
ihlr-18810	337	13	medical	medical	ADJ
ihlr-18810	337	14	device	device	NOUN
ihlr-18810	337	15	tracking	tracking	NOUN
ihlr-18810	337	16	,	,	PUNCT
ihlr-18810	337	17	fda.gov	fda.gov	NUM
ihlr-18810	337	18	,	,	PUNCT
ihlr-18810	337	19	http://www.fda.gov/medical	http://www.fda.gov/medical	ADJ
ihlr-18810	337	20	devices	device	NOUN
ihlr-18810	337	21	/	/	SYM
ihlr-18810	337	22	deviceregulationandguidance	deviceregulationandguidance	PROPN
ihlr-18810	337	23	/	/	SYM
ihlr-18810	337	24	postmarketrequirements/	postmarketrequirements/	NOUN
ihlr-18810	337	25	medicaldevicetracking	medicaldevicetracking	NOUN
ihlr-18810	337	26	/	/	SYM
ihlr-18810	337	27	default.htm	default.htm	X
ihlr-18810	337	28	(	(	PUNCT
ihlr-18810	337	29	last	last	ADV
ihlr-18810	337	30	visited	visit	VERB
ihlr-18810	337	31	nov	nov	PROPN
ihlr-18810	337	32	.	.	PROPN
ihlr-18810	337	33	27	27	NUM
ihlr-18810	337	34	,	,	PUNCT
ihlr-18810	337	35	2012	2012	NUM
ihlr-18810	337	36	)	)	PUNCT
ihlr-18810	337	37	.	.	PUNCT
ihlr-18810	338	1	124	124	NUM
ihlr-18810	339	1	i	i	PRON
ihlr-18810	339	2	d.	d.	PROPN
ihlr-18810	339	3	125	125	NUM
ihlr-18810	339	4	iom	iom	PROPN
ihlr-18810	339	5	report	report	NOUN
ihlr-18810	339	6	,	,	PUNCT
ihlr-18810	339	7	supra	supra	PROPN
ihlr-18810	339	8	note	note	NOUN
ihlr-18810	339	9	6	6	NUM
ihlr-18810	339	10	,	,	PUNCT
ihlr-18810	339	11	at	at	ADP
ihlr-18810	339	12	129	129	NUM
ihlr-18810	339	13	(	(	PUNCT
ihlr-18810	339	14	noting	note	VERB
ihlr-18810	339	15	that	that	SCONJ
ihlr-18810	339	16	information	information	NOUN
ihlr-18810	339	17	about	about	ADP
ihlr-18810	339	18	distributed	distribute	VERB
ihlr-18810	339	19	devices	device	NOUN
ihlr-18810	339	20	is	be	AUX
ihlr-18810	339	21	expected	expect	VERB
ihlr-18810	339	22	be	be	AUX
ihlr-18810	339	23	provided	provide	VERB
ihlr-18810	339	24	within	within	ADP
ihlr-18810	339	25	ten	ten	NUM
ihlr-18810	339	26	days	day	NOUN
ihlr-18810	339	27	,	,	PUNCT
ihlr-18810	339	28	and	and	CCONJ
ihlr-18810	339	29	information	information	NOUN
ihlr-18810	339	30	about	about	ADP
ihlr-18810	339	31	devices	device	NOUN
ihlr-18810	339	32	in	in	ADP
ihlr-18810	339	33	inventory	inventory	NOUN
ihlr-18810	339	34	within	within	ADP
ihlr-18810	339	35	three	three	NUM
ihlr-18810	339	36	days	day	NOUN
ihlr-18810	339	37	)	)	PUNCT
ihlr-18810	339	38	.	.	PUNCT
ihlr-18810	340	1	138	138	NUM
ihlr-18810	340	2	vol	vol	NOUN
ihlr-18810	340	3	.	.	PUNCT
ihlr-18810	341	1	10:1	10:1	NUM
ihlr-18810	341	2	510(k	510(k	X
ihlr-18810	341	3	)	)	PUNCT
ihlr-18810	341	4	clearance	clearance	NOUN
ihlr-18810	341	5	system	system	NOUN
ihlr-18810	341	6	.	.	PUNCT
ihlr-18810	342	1	126	126	NUM
ihlr-18810	342	2	although	although	SCONJ
ihlr-18810	342	3	pilot	pilot	NOUN
ihlr-18810	342	4	activities	activity	NOUN
ihlr-18810	342	5	have	have	AUX
ihlr-18810	342	6	been	be	AUX
ihlr-18810	342	7	conducted	conduct	VERB
ihlr-18810	342	8	,	,	PUNCT
ihlr-18810	342	9	this	this	PRON
ihlr-18810	342	10	has	have	AUX
ihlr-18810	342	11	not	not	PART
ihlr-18810	342	12	yet	yet	ADV
ihlr-18810	342	13	been	be	AUX
ihlr-18810	342	14	implemented.127	implemented.127	PROPN
ihlr-18810	342	15	manufacturers	manufacturer	NOUN
ihlr-18810	342	16	express	express	VERB
ihlr-18810	342	17	concern	concern	NOUN
ihlr-18810	342	18	about	about	ADP
ihlr-18810	342	19	the	the	DET
ihlr-18810	342	20	alignment	alignment	NOUN
ihlr-18810	342	21	of	of	ADP
ihlr-18810	342	22	the	the	DET
ihlr-18810	342	23	fda	fda	PROPN
ihlr-18810	342	24	's	's	PART
ihlr-18810	342	25	udi	udi	PROPN
ihlr-18810	342	26	standards	standard	NOUN
ihlr-18810	342	27	with	with	ADP
ihlr-18810	342	28	those	those	PRON
ihlr-18810	342	29	of	of	ADP
ihlr-18810	342	30	other	other	ADJ
ihlr-18810	342	31	regulatory	regulatory	ADJ
ihlr-18810	342	32	systems	system	NOUN
ihlr-18810	342	33	and	and	CCONJ
ihlr-18810	342	34	their	their	PRON
ihlr-18810	342	35	ability	ability	NOUN
ihlr-18810	342	36	to	to	PART
ihlr-18810	342	37	simultaneously	simultaneously	ADV
ihlr-18810	342	38	comply	comply	VERB
ihlr-18810	342	39	with	with	ADP
ihlr-18810	342	40	both.128	both.128	NOUN
ihlr-18810	342	41	the	the	DET
ihlr-18810	342	42	fda	fda	PROPN
ihlr-18810	342	43	has	have	AUX
ihlr-18810	342	44	also	also	ADV
ihlr-18810	342	45	established	establish	VERB
ihlr-18810	342	46	a	a	DET
ihlr-18810	342	47	postmarket	postmarket	ADJ
ihlr-18810	342	48	risk	risk	NOUN
ihlr-18810	342	49	identification	identification	NOUN
ihlr-18810	342	50	and	and	CCONJ
ihlr-18810	342	51	analysis	analysis	NOUN
ihlr-18810	342	52	system	system	NOUN
ihlr-18810	342	53	known	know	VERB
ihlr-18810	342	54	as	as	ADP
ihlr-18810	342	55	the	the	DET
ihlr-18810	342	56	sentinel	sentinel	ADJ
ihlr-18810	342	57	initiative	initiative	NOUN
ihlr-18810	342	58	to	to	PART
ihlr-18810	342	59	enable	enable	VERB
ihlr-18810	342	60	the	the	DET
ihlr-18810	342	61	active	active	ADJ
ihlr-18810	342	62	monitoring	monitoring	NOUN
ihlr-18810	342	63	of	of	ADP
ihlr-18810	342	64	the	the	DET
ihlr-18810	342	65	safety	safety	NOUN
ihlr-18810	342	66	of	of	ADP
ihlr-18810	342	67	all	all	PRON
ihlr-18810	342	68	fda	fda	PROPN
ihlr-18810	342	69	regulated	regulate	VERB
ihlr-18810	342	70	products.129	products.129	PROPN
ihlr-18810	342	71	prior	prior	ADV
ihlr-18810	342	72	to	to	ADP
ihlr-18810	342	73	this	this	DET
ihlr-18810	342	74	initiative	initiative	NOUN
ihlr-18810	342	75	,	,	PUNCT
ihlr-18810	342	76	the	the	DET
ihlr-18810	342	77	fda	fda	PROPN
ihlr-18810	342	78	had	have	AUX
ihlr-18810	342	79	generally	generally	ADV
ihlr-18810	342	80	worked	work	VERB
ihlr-18810	342	81	with	with	ADP
ihlr-18810	342	82	healthcare	healthcare	NOUN
ihlr-18810	342	83	systems	system	NOUN
ihlr-18810	342	84	individually	individually	ADV
ihlr-18810	342	85	to	to	PART
ihlr-18810	342	86	evaluate	evaluate	VERB
ihlr-18810	342	87	a	a	DET
ihlr-18810	342	88	particular	particular	ADJ
ihlr-18810	342	89	product	product	NOUN
ihlr-18810	342	90	's	's	PART
ihlr-18810	342	91	safety	safety	NOUN
ihlr-18810	342	92	issues	issue	NOUN
ihlr-18810	342	93	,	,	PUNCT
ihlr-18810	342	94	although	although	SCONJ
ihlr-18810	342	95	it	it	PRON
ihlr-18810	342	96	also	also	ADV
ihlr-18810	342	97	made	make	VERB
ihlr-18810	342	98	use	use	NOUN
ihlr-18810	342	99	of	of	ADP
ihlr-18810	342	100	administrative	administrative	ADJ
ihlr-18810	342	101	and	and	CCONJ
ihlr-18810	342	102	insurance	insurance	NOUN
ihlr-18810	342	103	claims	claim	NOUN
ihlr-18810	342	104	databases	database	NOUN
ihlr-18810	342	105	in	in	ADP
ihlr-18810	342	106	investigating	investigate	VERB
ihlr-18810	342	107	safety	safety	NOUN
ihlr-18810	342	108	of	of	ADP
ihlr-18810	342	109	products.130	products.130	PROPN
ihlr-18810	342	110	the	the	DET
ihlr-18810	342	111	sentinel	sentinel	NOUN
ihlr-18810	342	112	initiative	initiative	NOUN
ihlr-18810	342	113	aims	aim	VERB
ihlr-18810	342	114	to	to	PART
ihlr-18810	342	115	create	create	VERB
ihlr-18810	342	116	a	a	DET
ihlr-18810	342	117	linked	link	VERB
ihlr-18810	342	118	,	,	PUNCT
ihlr-18810	342	119	sustainable	sustainable	ADJ
ihlr-18810	342	120	system	system	NOUN
ihlr-18810	342	121	that	that	PRON
ihlr-18810	342	122	will	will	AUX
ihlr-18810	342	123	draw	draw	VERB
ihlr-18810	342	124	upon	upon	SCONJ
ihlr-18810	342	125	the	the	DET
ihlr-18810	342	126	electronic	electronic	ADJ
ihlr-18810	342	127	healthcare	healthcare	NOUN
ihlr-18810	342	128	data	datum	NOUN
ihlr-18810	342	129	of	of	ADP
ihlr-18810	342	130	many	many	ADJ
ihlr-18810	342	131	sources	source	NOUN
ihlr-18810	342	132	to	to	PART
ihlr-18810	342	133	enable	enable	VERB
ihlr-18810	342	134	continuous	continuous	ADJ
ihlr-18810	342	135	active	active	ADJ
ihlr-18810	342	136	monitoring	monitoring	NOUN
ihlr-18810	342	137	of	of	ADP
ihlr-18810	342	138	product	product	NOUN
ihlr-18810	342	139	safety.131	safety.131	ADP
ihlr-18810	342	140	the	the	DET
ihlr-18810	342	141	initiative	initiative	NOUN
ihlr-18810	342	142	is	be	AUX
ihlr-18810	342	143	still	still	ADV
ihlr-18810	342	144	in	in	ADP
ihlr-18810	342	145	its	its	PRON
ihlr-18810	342	146	early	early	ADJ
ihlr-18810	342	147	phases	phase	NOUN
ihlr-18810	342	148	of	of	ADP
ihlr-18810	342	149	system	system	NOUN
ihlr-18810	342	150	planning	planning	NOUN
ihlr-18810	342	151	and	and	CCONJ
ihlr-18810	342	152	design	design	NOUN
ihlr-18810	342	153	,	,	PUNCT
ihlr-18810	342	154	but	but	CCONJ
ihlr-18810	342	155	a	a	DET
ihlr-18810	342	156	pilot	pilot	NOUN
ihlr-18810	342	157	"	"	PUNCT
ihlr-18810	342	158	mini	mini	ADJ
ihlr-18810	342	159	-	-	ADJ
ihlr-18810	342	160	sentinel	sentinel	ADJ
ihlr-18810	342	161	"	"	PUNCT
ihlr-18810	342	162	project	project	NOUN
ihlr-18810	342	163	has	have	AUX
ihlr-18810	342	164	been	be	AUX
ihlr-18810	342	165	developed.132	developed.132	PROPN
ihlr-18810	342	166	this	this	DET
ihlr-18810	342	167	project	project	NOUN
ihlr-18810	342	168	analyzed	analyze	VERB
ihlr-18810	342	169	administrative	administrative	ADJ
ihlr-18810	342	170	claims	claim	NOUN
ihlr-18810	342	171	data	datum	NOUN
ihlr-18810	342	172	and	and	CCONJ
ihlr-18810	343	1	de	de	VERB
ihlr-18810	343	2	-	-	ADJ
ihlr-18810	343	3	identified	identify	VERB
ihlr-18810	343	4	electronic	electronic	ADJ
ihlr-18810	343	5	health	health	NOUN
ihlr-18810	343	6	record	record	NOUN
ihlr-18810	343	7	data	datum	NOUN
ihlr-18810	343	8	with	with	ADP
ihlr-18810	343	9	the	the	DET
ihlr-18810	343	10	hopes	hope	NOUN
ihlr-18810	343	11	of	of	ADP
ihlr-18810	343	12	uncovering	uncover	VERB
ihlr-18810	343	13	information	information	NOUN
ihlr-18810	343	14	about	about	ADP
ihlr-18810	343	15	medical	medical	ADJ
ihlr-18810	343	16	device	device	NOUN
ihlr-18810	343	17	exposures	exposure	NOUN
ihlr-18810	343	18	and	and	CCONJ
ihlr-18810	343	19	outcomes.133	outcomes.133	VERB
ihlr-18810	343	20	while	while	SCONJ
ihlr-18810	343	21	this	this	DET
ihlr-18810	343	22	126	126	NUM
ihlr-18810	343	23	food	food	NOUN
ihlr-18810	343	24	and	and	CCONJ
ihlr-18810	343	25	drug	drug	PROPN
ihlr-18810	343	26	administration	administration	PROPN
ihlr-18810	343	27	amendments	amendment	NOUN
ihlr-18810	343	28	act	act	VERB
ihlr-18810	343	29	of	of	ADP
ihlr-18810	343	30	2007	2007	NUM
ihlr-18810	343	31	,	,	PUNCT
ihlr-18810	343	32	p.l	p.l	PROPN
ihlr-18810	343	33	.	.	NOUN
ihlr-18810	343	34	110	110	NUM
ihlr-18810	343	35	-	-	SYM
ihlr-18810	343	36	85	85	NUM
ihlr-18810	343	37	,	,	PUNCT
ihlr-18810	343	38	§	§	PROPN
ihlr-18810	343	39	226	226	NUM
ihlr-18810	343	40	,	,	PUNCT
ihlr-18810	343	41	121	121	NUM
ihlr-18810	343	42	stat	stat	NOUN
ihlr-18810	343	43	.	.	PUNCT
ihlr-18810	344	1	823	823	NUM
ihlr-18810	344	2	,	,	PUNCT
ihlr-18810	344	3	854	854	NUM
ihlr-18810	344	4	(	(	PUNCT
ihlr-18810	344	5	codified	codify	VERB
ihlr-18810	344	6	as	as	SCONJ
ihlr-18810	344	7	amended	amend	VERB
ihlr-18810	344	8	at	at	ADP
ihlr-18810	344	9	21	21	NUM
ihlr-18810	344	10	u.s.c	u.s.c	NOUN
ihlr-18810	344	11	.	.	PUNCT
ihlr-18810	345	1	360i	360i	NUM
ihlr-18810	345	2	(	(	PUNCT
ihlr-18810	345	3	2007	2007	NUM
ihlr-18810	345	4	)	)	PUNCT
ihlr-18810	345	5	)	)	PUNCT
ihlr-18810	345	6	.	.	PUNCT
ihlr-18810	346	1	127	127	NUM
ihlr-18810	346	2	iom	iom	PROPN
ihlr-18810	346	3	report	report	NOUN
ihlr-18810	346	4	,	,	PUNCT
ihlr-18810	346	5	supra	supra	PROPN
ihlr-18810	346	6	note	note	NOUN
ihlr-18810	346	7	6	6	NUM
ihlr-18810	346	8	,	,	PUNCT
ihlr-18810	346	9	at	at	ADP
ihlr-18810	346	10	133	133	NUM
ihlr-18810	346	11	.	.	PUNCT
ihlr-18810	346	12	128	128	NUM
ihlr-18810	347	1	i	i	NOUN
ihlr-18810	347	2	d.	d.	PROPN
ihlr-18810	347	3	129	129	NUM
ihlr-18810	348	1	fda	fda	PROPN
ihlr-18810	348	2	's	's	PART
ihlr-18810	348	3	sentinel	sentinel	ADJ
ihlr-18810	348	4	initiative	initiative	NOUN
ihlr-18810	348	5	background	background	NOUN
ihlr-18810	348	6	,	,	PUNCT
ihlr-18810	348	7	fda.gov	fda.gov	NUM
ihlr-18810	348	8	,	,	PUNCT
ihlr-18810	348	9	http://www.fda.gov/safety/fdassentinel	http://www.fda.gov/safety/fdassentinel	NOUN
ihlr-18810	348	10	initiative	initiative	NOUN
ihlr-18810	348	11	/	/	SYM
ihlr-18810	348	12	ucml49340.htm	ucml49340.htm	NOUN
ihlr-18810	348	13	(	(	PUNCT
ihlr-18810	348	14	last	last	ADV
ihlr-18810	348	15	visited	visit	VERB
ihlr-18810	348	16	dec	dec	PROPN
ihlr-18810	348	17	.	.	PROPN
ihlr-18810	348	18	21	21	NUM
ihlr-18810	348	19	,	,	PUNCT
ihlr-18810	348	20	2012	2012	NUM
ihlr-18810	348	21	)	)	PUNCT
ihlr-18810	349	1	[	[	X
ihlr-18810	349	2	hereinafter	hereinafter	NOUN
ihlr-18810	349	3	sentinel	sentinel	ADJ
ihlr-18810	349	4	initiative	initiative	NOUN
ihlr-18810	349	5	]	]	PUNCT
ihlr-18810	349	6	;	;	PUNCT
ihlr-18810	349	7	see	see	VERB
ihlr-18810	349	8	also	also	ADV
ihlr-18810	349	9	food	food	NOUN
ihlr-18810	349	10	and	and	CCONJ
ihlr-18810	349	11	drug	drug	PROPN
ihlr-18810	349	12	administration	administration	PROPN
ihlr-18810	349	13	amendments	amendment	NOUN
ihlr-18810	349	14	act	act	VERB
ihlr-18810	349	15	of	of	ADP
ihlr-18810	349	16	2007	2007	NUM
ihlr-18810	349	17	,	,	PUNCT
ihlr-18810	349	18	p.l	p.l	PROPN
ihlr-18810	349	19	.	.	NOUN
ihlr-18810	349	20	110	110	NUM
ihlr-18810	349	21	-	-	SYM
ihlr-18810	349	22	85	85	NUM
ihlr-18810	349	23	,	,	PUNCT
ihlr-18810	349	24	§	§	PROPN
ihlr-18810	349	25	905(a	905(a	PROPN
ihlr-18810	349	26	)	)	PUNCT
ihlr-18810	349	27	,	,	PUNCT
ihlr-18810	349	28	121	121	NUM
ihlr-18810	349	29	stat	stat	NOUN
ihlr-18810	349	30	.	.	PUNCT
ihlr-18810	350	1	823	823	NUM
ihlr-18810	350	2	,	,	PUNCT
ihlr-18810	350	3	944	944	NUM
ihlr-18810	350	4	(	(	PUNCT
ihlr-18810	350	5	codified	codify	VERB
ihlr-18810	350	6	as	as	SCONJ
ihlr-18810	350	7	amended	amend	VERB
ihlr-18810	350	8	at	at	ADP
ihlr-18810	350	9	21	21	NUM
ihlr-18810	350	10	u.s.c	u.s.c	ADJ
ihlr-18810	350	11	.	.	PUNCT
ihlr-18810	351	1	§	§	PROPN
ihlr-18810	351	2	355	355	NUM
ihlr-18810	351	3	(	(	PUNCT
ihlr-18810	351	4	2007	2007	NUM
ihlr-18810	351	5	)	)	PUNCT
ihlr-18810	351	6	)	)	PUNCT
ihlr-18810	352	1	(	(	PUNCT
ihlr-18810	352	2	noting	note	VERB
ihlr-18810	352	3	that	that	SCONJ
ihlr-18810	352	4	the	the	DET
ihlr-18810	352	5	sentinel	sentinel	ADJ
ihlr-18810	352	6	initiative	initiative	NOUN
ihlr-18810	352	7	was	be	AUX
ihlr-18810	352	8	to	to	PART
ihlr-18810	352	9	establish	establish	VERB
ihlr-18810	352	10	and	and	CCONJ
ihlr-18810	352	11	maintain	maintain	VERB
ihlr-18810	352	12	procedures	procedure	NOUN
ihlr-18810	352	13	for	for	ADP
ihlr-18810	352	14	"	"	PUNCT
ihlr-18810	352	15	risk	risk	NOUN
ihlr-18810	352	16	identification	identification	NOUN
ihlr-18810	352	17	and	and	CCONJ
ihlr-18810	352	18	analysis	analysis	NOUN
ihlr-18810	352	19	...	...	PUNCT
ihlr-18810	352	20	of	of	ADP
ihlr-18810	352	21	data	datum	NOUN
ihlr-18810	352	22	on	on	ADP
ihlr-18810	352	23	all	all	DET
ihlr-18810	352	24	serious	serious	ADJ
ihlr-18810	352	25	adverse	adverse	ADJ
ihlr-18810	352	26	drug	drug	NOUN
ihlr-18810	352	27	experiences	experience	NOUN
ihlr-18810	352	28	"	"	PUNCT
ihlr-18810	352	29	)	)	PUNCT
ihlr-18810	352	30	;	;	PUNCT
ihlr-18810	352	31	but	but	CCONJ
ihlr-18810	352	32	see	see	VERB
ihlr-18810	352	33	iom	iom	PROPN
ihlr-18810	352	34	report	report	PROPN
ihlr-18810	352	35	,	,	PUNCT
ihlr-18810	352	36	supra	supra	PROPN
ihlr-18810	352	37	note	note	NOUN
ihlr-18810	352	38	6	6	NUM
ihlr-18810	352	39	,	,	PUNCT
ihlr-18810	352	40	at	at	ADP
ihlr-18810	352	41	131	131	NUM
ihlr-18810	352	42	(	(	PUNCT
ihlr-18810	352	43	noting	note	VERB
ihlr-18810	352	44	that	that	SCONJ
ihlr-18810	352	45	the	the	DET
ihlr-18810	352	46	fda	fda	PROPN
ihlr-18810	352	47	,	,	PUNCT
ihlr-18810	352	48	through	through	ADP
ihlr-18810	352	49	its	its	PRON
ihlr-18810	352	50	general	general	ADJ
ihlr-18810	352	51	authority	authority	NOUN
ihlr-18810	352	52	under	under	ADP
ihlr-18810	352	53	fdca	fdca	ADJ
ihlr-18810	352	54	section	section	NOUN
ihlr-18810	352	55	1003(b)(2)(c	1003(b)(2)(c	NUM
ihlr-18810	352	56	)	)	PUNCT
ihlr-18810	352	57	has	have	AUX
ihlr-18810	352	58	broadened	broaden	VERB
ihlr-18810	352	59	the	the	DET
ihlr-18810	352	60	scope	scope	NOUN
ihlr-18810	352	61	of	of	ADP
ihlr-18810	352	62	the	the	DET
ihlr-18810	352	63	sentinel	sentinel	ADJ
ihlr-18810	352	64	system	system	NOUN
ihlr-18810	352	65	to	to	PART
ihlr-18810	352	66	include	include	VERB
ihlr-18810	352	67	medical	medical	ADJ
ihlr-18810	352	68	devices	device	NOUN
ihlr-18810	352	69	)	)	PUNCT
ihlr-18810	352	70	.	.	PUNCT
ihlr-18810	353	1	130	130	NUM
ihlr-18810	353	2	sentinel	sentinel	ADJ
ihlr-18810	353	3	initiative	initiative	NOUN
ihlr-18810	353	4	,	,	PUNCT
ihlr-18810	353	5	supra	supra	PROPN
ihlr-18810	353	6	notel29	notel29	PROPN
ihlr-18810	353	7	.	.	PUNCT
ihlr-18810	354	1	131	131	NUM
ihlr-18810	355	1	i	i	PRON
ihlr-18810	355	2	d.	d.	PROPN
ihlr-18810	355	3	132	132	NUM
ihlr-18810	355	4	iom	iom	PROPN
ihlr-18810	355	5	report	report	NOUN
ihlr-18810	355	6	,	,	PUNCT
ihlr-18810	355	7	supra	supra	PROPN
ihlr-18810	355	8	note	note	NOUN
ihlr-18810	355	9	6	6	NUM
ihlr-18810	355	10	,	,	PUNCT
ihlr-18810	355	11	at	at	ADP
ihlr-18810	355	12	131	131	NUM
ihlr-18810	355	13	.	.	PUNCT
ihlr-18810	356	1	133	133	NUM
ihlr-18810	356	2	i	i	PROPN
ihlr-18810	356	3	d.	d.	PROPN
ihlr-18810	356	4	;	;	PUNCT
ihlr-18810	356	5	see	see	VERB
ihlr-18810	356	6	also	also	ADV
ihlr-18810	356	7	background	background	NOUN
ihlr-18810	356	8	'	'	PUNCT
ihlr-18810	356	9	history	history	NOUN
ihlr-18810	356	10	,	,	PUNCT
ihlr-18810	356	11	mini-sentinel.org	mini-sentinel.org	NOUN
ihlr-18810	356	12	,	,	PUNCT
ihlr-18810	356	13	http://	http://	PROPN
ihlr-18810	356	14	mini-sentinel.org/aboutus/	mini-sentinel.org/aboutus/	PROPN
ihlr-18810	356	15	(	(	PUNCT
ihlr-18810	356	16	last	last	ADV
ihlr-18810	356	17	visited	visit	VERB
ihlr-18810	356	18	nov	nov	PROPN
ihlr-18810	356	19	.	.	PROPN
ihlr-18810	356	20	27	27	NUM
ihlr-18810	356	21	,	,	PUNCT
ihlr-18810	356	22	2012	2012	NUM
ihlr-18810	356	23	)	)	PUNCT
ihlr-18810	356	24	.	.	PUNCT
ihlr-18810	357	1	2013	2013	NUM
ihlr-18810	357	2	139	139	NUM
ihlr-18810	357	3	indiana	indiana	PROPN
ihlr-18810	357	4	health	health	PROPN
ihlr-18810	357	5	law	law	PROPN
ihlr-18810	357	6	review	review	NOUN
ihlr-18810	357	7	initiative	initiative	NOUN
ihlr-18810	357	8	will	will	AUX
ihlr-18810	357	9	greatly	greatly	ADV
ihlr-18810	357	10	facilitate	facilitate	VERB
ihlr-18810	357	11	the	the	DET
ihlr-18810	357	12	monitoring	monitoring	NOUN
ihlr-18810	357	13	of	of	ADP
ihlr-18810	357	14	fda	fda	PROPN
ihlr-18810	357	15	regulated	regulate	VERB
ihlr-18810	357	16	products	product	NOUN
ihlr-18810	357	17	,	,	PUNCT
ihlr-18810	357	18	its	its	PRON
ihlr-18810	357	19	ability	ability	NOUN
ihlr-18810	357	20	to	to	PART
ihlr-18810	357	21	improve	improve	VERB
ihlr-18810	357	22	the	the	DET
ihlr-18810	357	23	monitoring	monitoring	NOUN
ihlr-18810	357	24	of	of	ADP
ihlr-18810	357	25	510(k	510(k	PROPN
ihlr-18810	357	26	)	)	PUNCT
ihlr-18810	357	27	cleared	clear	VERB
ihlr-18810	357	28	devices	device	NOUN
ihlr-18810	357	29	is	be	AUX
ihlr-18810	357	30	limited	limited	ADJ
ihlr-18810	357	31	.	.	PUNCT
ihlr-18810	358	1	information	information	NOUN
ihlr-18810	358	2	about	about	ADP
ihlr-18810	358	3	many	many	ADJ
ihlr-18810	358	4	issues	issue	NOUN
ihlr-18810	358	5	,	,	PUNCT
ihlr-18810	358	6	such	such	ADJ
ihlr-18810	358	7	as	as	ADP
ihlr-18810	358	8	software	software	NOUN
ihlr-18810	358	9	problems	problem	NOUN
ihlr-18810	358	10	,	,	PUNCT
ihlr-18810	358	11	manufacturing	manufacturing	NOUN
ihlr-18810	358	12	defects	defect	NOUN
ihlr-18810	358	13	,	,	PUNCT
ihlr-18810	358	14	packaging	packaging	NOUN
ihlr-18810	358	15	and	and	CCONJ
ihlr-18810	358	16	labeling	labeling	NOUN
ihlr-18810	358	17	errors	error	NOUN
ihlr-18810	358	18	,	,	PUNCT
ihlr-18810	358	19	and	and	CCONJ
ihlr-18810	358	20	errors	error	NOUN
ihlr-18810	358	21	resulting	result	VERB
ihlr-18810	358	22	from	from	ADP
ihlr-18810	358	23	device	device	NOUN
ihlr-18810	358	24	design	design	NOUN
ihlr-18810	358	25	,	,	PUNCT
ihlr-18810	358	26	will	will	AUX
ihlr-18810	358	27	not	not	PART
ihlr-18810	358	28	be	be	AUX
ihlr-18810	358	29	gathered	gather	VERB
ihlr-18810	358	30	,	,	PUNCT
ihlr-18810	358	31	leaving	leave	VERB
ihlr-18810	358	32	many	many	ADJ
ihlr-18810	358	33	potential	potential	ADJ
ihlr-18810	358	34	safety	safety	NOUN
ihlr-18810	358	35	consequences	consequence	NOUN
ihlr-18810	358	36	of	of	ADP
ihlr-18810	358	37	510(k	510(k	PROPN
ihlr-18810	358	38	)	)	PUNCT
ihlr-18810	358	39	devices	device	NOUN
ihlr-18810	358	40	beyond	beyond	ADP
ihlr-18810	358	41	the	the	DET
ihlr-18810	358	42	scope	scope	NOUN
ihlr-18810	358	43	of	of	ADP
ihlr-18810	358	44	the	the	DET
ihlr-18810	358	45	initiative	initiative	NOUN
ihlr-18810	358	46	's	's	PART
ihlr-18810	358	47	active	active	ADJ
ihlr-18810	358	48	monitoring	monitoring	NOUN
ihlr-18810	358	49	.	.	PUNCT
ihlr-18810	359	1	134	134	NUM
ihlr-18810	359	2	the	the	DET
ihlr-18810	359	3	database	database	NOUN
ihlr-18810	359	4	created	create	VERB
ihlr-18810	359	5	by	by	ADP
ihlr-18810	359	6	the	the	DET
ihlr-18810	359	7	mini	mini	ADJ
ihlr-18810	359	8	-	-	ADJ
ihlr-18810	359	9	sentinel	sentinel	ADJ
ihlr-18810	359	10	program	program	NOUN
ihlr-18810	359	11	can	can	AUX
ihlr-18810	359	12	be	be	AUX
ihlr-18810	359	13	used	use	VERB
ihlr-18810	359	14	to	to	PART
ihlr-18810	359	15	make	make	VERB
ihlr-18810	359	16	assessments	assessment	NOUN
ihlr-18810	359	17	describing	describe	VERB
ihlr-18810	359	18	"	"	PUNCT
ihlr-18810	359	19	exposures	exposure	NOUN
ihlr-18810	359	20	to	to	ADP
ihlr-18810	359	21	medical	medical	ADJ
ihlr-18810	359	22	products	product	NOUN
ihlr-18810	359	23	,	,	PUNCT
ihlr-18810	359	24	occurrences	occurrence	NOUN
ihlr-18810	359	25	of	of	ADP
ihlr-18810	359	26	particular	particular	ADJ
ihlr-18810	359	27	diagnoses	diagnosis	NOUN
ihlr-18810	359	28	and	and	CCONJ
ihlr-18810	359	29	medical	medical	ADJ
ihlr-18810	359	30	procedures	procedure	NOUN
ihlr-18810	359	31	,	,	PUNCT
ihlr-18810	359	32	health	health	NOUN
ihlr-18810	359	33	outcomes	outcome	NOUN
ihlr-18810	359	34	among	among	ADP
ihlr-18810	359	35	individuals	individual	NOUN
ihlr-18810	359	36	exposed	expose	VERB
ihlr-18810	359	37	to	to	ADP
ihlr-18810	359	38	medical	medical	ADJ
ihlr-18810	359	39	products	product	NOUN
ihlr-18810	359	40	,	,	PUNCT
ihlr-18810	359	41	[	[	X
ihlr-18810	359	42	and	and	CCONJ
ihlr-18810	359	43	the	the	DET
ihlr-18810	359	44	]	]	X
ihlr-18810	359	45	impact	impact	NOUN
ihlr-18810	359	46	of	of	ADP
ihlr-18810	359	47	fda	fda	PROPN
ihlr-18810	359	48	's	's	PART
ihlr-18810	359	49	regulatory	regulatory	ADJ
ihlr-18810	359	50	actions	action	NOUN
ihlr-18810	359	51	and	and	CCONJ
ihlr-18810	359	52	interventions	intervention	NOUN
ihlr-18810	359	53	.	.	PUNCT
ihlr-18810	360	1	"135	"135	PROPN
ihlr-18810	360	2	another	another	DET
ihlr-18810	360	3	pilot	pilot	NOUN
ihlr-18810	360	4	program	program	NOUN
ihlr-18810	360	5	,	,	PUNCT
ihlr-18810	360	6	known	know	VERB
ihlr-18810	360	7	as	as	ADP
ihlr-18810	360	8	the	the	DET
ihlr-18810	360	9	medical	medical	ADJ
ihlr-18810	360	10	product	product	NOUN
ihlr-18810	360	11	surveillance	surveillance	NOUN
ihlr-18810	360	12	network	network	NOUN
ihlr-18810	360	13	(	(	PUNCT
ihlr-18810	360	14	medsun	medsun	NOUN
ihlr-18810	360	15	)	)	PUNCT
ihlr-18810	360	16	,	,	PUNCT
ihlr-18810	360	17	was	be	AUX
ihlr-18810	360	18	implemented	implement	VERB
ihlr-18810	360	19	in	in	ADP
ihlr-18810	360	20	an	an	DET
ihlr-18810	360	21	effort	effort	NOUN
ihlr-18810	360	22	to	to	PART
ihlr-18810	360	23	improve	improve	VERB
ihlr-18810	360	24	the	the	DET
ihlr-18810	360	25	reporting	reporting	NOUN
ihlr-18810	360	26	of	of	ADP
ihlr-18810	360	27	adverse	adverse	ADJ
ihlr-18810	360	28	events	event	NOUN
ihlr-18810	360	29	and	and	CCONJ
ihlr-18810	360	30	near	near	ADJ
ihlr-18810	360	31	misses	miss	NOUN
ihlr-18810	360	32	through	through	ADP
ihlr-18810	360	33	the	the	DET
ihlr-18810	360	34	involvement	involvement	NOUN
ihlr-18810	360	35	of	of	ADP
ihlr-18810	360	36	trained	train	VERB
ihlr-18810	360	37	risk	risk	NOUN
ihlr-18810	360	38	managers	manager	NOUN
ihlr-18810	360	39	at	at	ADP
ihlr-18810	360	40	various	various	ADJ
ihlr-18810	360	41	health	health	NOUN
ihlr-18810	360	42	facilities	facility	NOUN
ihlr-18810	360	43	.	.	PUNCT
ihlr-18810	361	1	136	136	NUM
ihlr-18810	362	1	the	the	DET
ihlr-18810	362	2	hope	hope	NOUN
ihlr-18810	362	3	is	be	AUX
ihlr-18810	362	4	that	that	SCONJ
ihlr-18810	362	5	the	the	DET
ihlr-18810	362	6	involvement	involvement	NOUN
ihlr-18810	362	7	of	of	ADP
ihlr-18810	362	8	clinical	clinical	ADJ
ihlr-18810	362	9	professionals	professional	NOUN
ihlr-18810	362	10	could	could	AUX
ihlr-18810	362	11	improve	improve	VERB
ihlr-18810	362	12	not	not	PART
ihlr-18810	362	13	only	only	ADV
ihlr-18810	362	14	the	the	DET
ihlr-18810	362	15	number	number	NOUN
ihlr-18810	362	16	of	of	ADP
ihlr-18810	362	17	events	event	NOUN
ihlr-18810	362	18	reported	report	VERB
ihlr-18810	362	19	,	,	PUNCT
ihlr-18810	362	20	but	but	CCONJ
ihlr-18810	362	21	also	also	ADV
ihlr-18810	362	22	the	the	DET
ihlr-18810	362	23	quality	quality	NOUN
ihlr-18810	362	24	of	of	ADP
ihlr-18810	362	25	the	the	DET
ihlr-18810	362	26	information	information	NOUN
ihlr-18810	362	27	reported	report	VERB
ihlr-18810	362	28	,	,	PUNCT
ihlr-18810	362	29	137	137	NUM
ihlr-18810	362	30	through	through	ADP
ihlr-18810	362	31	the	the	DET
ihlr-18810	362	32	program	program	NOUN
ihlr-18810	362	33	's	's	PART
ihlr-18810	362	34	creation	creation	NOUN
ihlr-18810	362	35	of	of	ADP
ihlr-18810	362	36	a	a	DET
ihlr-18810	362	37	two	two	NUM
ihlr-18810	362	38	-	-	PUNCT
ihlr-18810	362	39	way	way	NOUN
ihlr-18810	362	40	communication	communication	NOUN
ihlr-18810	362	41	pathway	pathway	NOUN
ihlr-18810	362	42	between	between	ADP
ihlr-18810	362	43	the	the	DET
ihlr-18810	362	44	fda	fda	PROPN
ihlr-18810	362	45	and	and	CCONJ
ihlr-18810	362	46	the	the	DET
ihlr-18810	362	47	clinical	clinical	ADJ
ihlr-18810	362	48	site	site	NOUN
ihlr-18810	362	49	of	of	ADP
ihlr-18810	362	50	care	care	NOUN
ihlr-18810	362	51	.	.	PUNCT
ihlr-18810	363	1	138	138	NUM
ihlr-18810	363	2	the	the	DET
ihlr-18810	363	3	information	information	NOUN
ihlr-18810	363	4	obtained	obtain	VERB
ihlr-18810	363	5	could	could	AUX
ihlr-18810	363	6	be	be	AUX
ihlr-18810	363	7	analyzed	analyze	VERB
ihlr-18810	363	8	to	to	PART
ihlr-18810	363	9	uncover	uncover	VERB
ihlr-18810	363	10	how	how	SCONJ
ihlr-18810	363	11	devices	device	NOUN
ihlr-18810	363	12	are	be	AUX
ihlr-18810	363	13	used	use	VERB
ihlr-18810	363	14	and	and	CCONJ
ihlr-18810	363	15	how	how	SCONJ
ihlr-18810	363	16	errors	error	NOUN
ihlr-18810	363	17	occur	occur	VERB
ihlr-18810	363	18	,	,	PUNCT
ihlr-18810	363	19	to	to	PART
ihlr-18810	363	20	prevent	prevent	VERB
ihlr-18810	363	21	injuries	injury	NOUN
ihlr-18810	363	22	from	from	ADP
ihlr-18810	363	23	reoccurring	reoccurre	VERB
ihlr-18810	363	24	in	in	ADP
ihlr-18810	363	25	future	future	ADJ
ihlr-18810	363	26	uses	use	NOUN
ihlr-18810	363	27	of	of	ADP
ihlr-18810	363	28	the	the	DET
ihlr-18810	363	29	devices	device	NOUN
ihlr-18810	363	30	,	,	PUNCT
ihlr-18810	363	31	while	while	SCONJ
ihlr-18810	363	32	also	also	ADV
ihlr-18810	363	33	identify	identify	VERB
ihlr-18810	363	34	-	-	PUNCT
ihlr-18810	363	35	ing	ing	ADJ
ihlr-18810	363	36	trends	trend	NOUN
ihlr-18810	363	37	that	that	PRON
ihlr-18810	363	38	hopefully	hopefully	ADV
ihlr-18810	363	39	could	could	AUX
ihlr-18810	363	40	identify	identify	VERB
ihlr-18810	363	41	developing	develop	VERB
ihlr-18810	363	42	problems	problem	NOUN
ihlr-18810	363	43	and	and	CCONJ
ihlr-18810	363	44	enable	enable	VERB
ihlr-18810	363	45	them	they	PRON
ihlr-18810	363	46	to	to	PART
ihlr-18810	363	47	be	be	AUX
ihlr-18810	363	48	addressed	address	VERB
ihlr-18810	363	49	earlier	early	ADV
ihlr-18810	363	50	,	,	PUNCT
ihlr-18810	363	51	to	to	PART
ihlr-18810	363	52	prevent	prevent	VERB
ihlr-18810	363	53	injuries	injury	NOUN
ihlr-18810	363	54	from	from	ADP
ihlr-18810	363	55	occurring	occur	VERB
ihlr-18810	363	56	at	at	ADP
ihlr-18810	363	57	all.139	all.139	NOUN
ihlr-18810	363	58	134	134	NUM
ihlr-18810	363	59	iom	iom	PROPN
ihlr-18810	363	60	report	report	NOUN
ihlr-18810	363	61	,	,	PUNCT
ihlr-18810	363	62	supra	supra	PROPN
ihlr-18810	363	63	note	note	NOUN
ihlr-18810	363	64	6	6	NUM
ihlr-18810	363	65	,	,	PUNCT
ihlr-18810	363	66	at	at	ADP
ihlr-18810	363	67	132	132	NUM
ihlr-18810	363	68	.	.	NOUN
ihlr-18810	363	69	135	135	NUM
ihlr-18810	363	70	types	type	NOUN
ihlr-18810	363	71	of	of	ADP
ihlr-18810	363	72	assessments	assessment	NOUN
ihlr-18810	363	73	,	,	PUNCT
ihlr-18810	363	74	minisentinel.org	minisentinel.org	X
ihlr-18810	363	75	,	,	PUNCT
ihlr-18810	363	76	http://minisentinel	http://minisentinel	X
ihlr-18810	363	77	.	.	PUNCT
ihlr-18810	363	78	org	org	ADJ
ihlr-18810	363	79	/	/	SYM
ihlr-18810	363	80	product	product	NOUN
ihlr-18810	363	81	-	-	PUNCT
ihlr-18810	363	82	evaluations/	evaluations/	NUM
ihlr-18810	363	83	default.aspx	default.aspx	NOUN
ihlr-18810	363	84	(	(	PUNCT
ihlr-18810	363	85	last	last	ADV
ihlr-18810	363	86	visited	visit	VERB
ihlr-18810	363	87	nov	nov	PROPN
ihlr-18810	363	88	.	.	PROPN
ihlr-18810	363	89	27	27	NUM
ihlr-18810	363	90	,	,	PUNCT
ihlr-18810	363	91	2012	2012	NUM
ihlr-18810	363	92	)	)	PUNCT
ihlr-18810	363	93	.	.	PUNCT
ihlr-18810	364	1	136	136	NUM
ihlr-18810	364	2	iom	iom	PROPN
ihlr-18810	364	3	report	report	NOUN
ihlr-18810	364	4	,	,	PUNCT
ihlr-18810	364	5	supra	supra	PROPN
ihlr-18810	364	6	note	note	NOUN
ihlr-18810	364	7	6	6	NUM
ihlr-18810	364	8	,	,	PUNCT
ihlr-18810	364	9	at	at	ADP
ihlr-18810	364	10	129	129	NUM
ihlr-18810	364	11	.	.	PUNCT
ihlr-18810	364	12	137	137	NUM
ihlr-18810	365	1	i	i	PROPN
ihlr-18810	365	2	d.	d.	PROPN
ihlr-18810	365	3	138	138	NUM
ihlr-18810	365	4	susan	susan	PROPN
ihlr-18810	365	5	gardner	gardner	PROPN
ihlr-18810	365	6	&	&	CCONJ
ihlr-18810	365	7	marilyn	marilyn	PROPN
ihlr-18810	365	8	flack	flack	PROPN
ihlr-18810	365	9	,	,	PUNCT
ihlr-18810	365	10	designing	design	VERB
ihlr-18810	365	11	a	a	DET
ihlr-18810	365	12	medical	medical	ADJ
ihlr-18810	365	13	device	device	NOUN
ihlr-18810	365	14	surveillance	surveillance	NOUN
ihlr-18810	365	15	network	network	NOUN
ihlr-18810	365	16	:	:	PUNCT
ihlr-18810	365	17	report	report	NOUN
ihlr-18810	365	18	to	to	ADP
ihlr-18810	365	19	congress	congress	PROPN
ihlr-18810	365	20	(	(	PUNCT
ihlr-18810	365	21	1999	1999	NUM
ihlr-18810	365	22	)	)	PUNCT
ihlr-18810	366	1	[	[	X
ihlr-18810	366	2	hereinafter	hereinafter	NOUN
ihlr-18810	366	3	medsun	medsun	NOUN
ihlr-18810	366	4	]	]	X
ihlr-18810	366	5	,	,	PUNCT
ihlr-18810	366	6	available	available	ADJ
ihlr-18810	366	7	at	at	ADP
ihlr-18810	366	8	http://www.fda.gov/medicaldevices/	http://www.fda.gov/medicaldevices/	PROPN
ihlr-18810	366	9	deviceregulationandguidance	deviceregulationandguidance	PROPN
ihlr-18810	366	10	/	/	SYM
ihlr-18810	366	11	overviewmedicaldeviceprovisionsoffdamod	overviewmedicaldeviceprovisionsoffdamod	PROPN
ihlr-18810	366	12	ernizationact	ernizationact	NOUN
ihlr-18810	366	13	/	/	SYM
ihlr-18810	366	14	ucml68938.htm	ucml68938.htm	NOUN
ihlr-18810	366	15	.	.	PUNCT
ihlr-18810	367	1	139	139	NUM
ihlr-18810	368	1	i	i	PRON
ihlr-18810	368	2	d.	d.	PROPN
ihlr-18810	368	3	at	at	ADP
ihlr-18810	368	4	§	§	PROPN
ihlr-18810	368	5	5.1	5.1	NUM
ihlr-18810	368	6	.	.	PUNCT
ihlr-18810	368	7	140	140	NUM
ihlr-18810	368	8	vol	vol	NOUN
ihlr-18810	368	9	.	.	PUNCT
ihlr-18810	369	1	10:1	10:1	NUM
ihlr-18810	369	2	510(k	510(k	NUM
ihlr-18810	369	3	)	)	PUNCT
ihlr-18810	369	4	clearance	clearance	NOUN
ihlr-18810	369	5	finally	finally	ADV
ihlr-18810	369	6	,	,	PUNCT
ihlr-18810	369	7	section	section	NOUN
ihlr-18810	369	8	522	522	NUM
ihlr-18810	369	9	of	of	ADP
ihlr-18810	369	10	the	the	DET
ihlr-18810	369	11	fdca	fdca	NOUN
ihlr-18810	369	12	grants	grant	VERB
ihlr-18810	369	13	the	the	DET
ihlr-18810	369	14	fda	fda	PROPN
ihlr-18810	369	15	the	the	DET
ihlr-18810	369	16	discretion	discretion	NOUN
ihlr-18810	369	17	to	to	PART
ihlr-18810	369	18	order	order	VERB
ihlr-18810	369	19	any	any	DET
ihlr-18810	369	20	manufacturer	manufacturer	NOUN
ihlr-18810	369	21	to	to	PART
ihlr-18810	369	22	conduct	conduct	VERB
ihlr-18810	369	23	post	post	NOUN
ihlr-18810	369	24	market	market	NOUN
ihlr-18810	369	25	surveillance	surveillance	NOUN
ihlr-18810	369	26	on	on	ADP
ihlr-18810	369	27	certain	certain	ADJ
ihlr-18810	369	28	class	class	NOUN
ihlr-18810	369	29	ii	ii	NOUN
ihlr-18810	369	30	or	or	CCONJ
ihlr-18810	369	31	class	class	NOUN
ihlr-18810	369	32	iii	iii	NOUN
ihlr-18810	369	33	devices.140	devices.140	ADJ
ihlr-18810	369	34	devices	device	NOUN
ihlr-18810	369	35	for	for	ADP
ihlr-18810	369	36	which	which	PRON
ihlr-18810	369	37	postmarket	postmarket	ADJ
ihlr-18810	369	38	surveillance	surveillance	NOUN
ihlr-18810	369	39	can	can	AUX
ihlr-18810	369	40	be	be	AUX
ihlr-18810	369	41	ordered	order	VERB
ihlr-18810	369	42	include	include	VERB
ihlr-18810	369	43	those	those	PRON
ihlr-18810	369	44	whose	whose	DET
ihlr-18810	369	45	failure	failure	NOUN
ihlr-18810	369	46	is	be	AUX
ihlr-18810	369	47	reasonably	reasonably	ADV
ihlr-18810	369	48	likely	likely	ADJ
ihlr-18810	369	49	to	to	PART
ihlr-18810	369	50	have	have	VERB
ihlr-18810	369	51	serious	serious	ADJ
ihlr-18810	369	52	adverse	adverse	ADJ
ihlr-18810	369	53	health	health	NOUN
ihlr-18810	369	54	consequences	consequence	NOUN
ihlr-18810	369	55	,	,	PUNCT
ihlr-18810	369	56	which	which	PRON
ihlr-18810	369	57	are	be	AUX
ihlr-18810	369	58	intended	intend	VERB
ihlr-18810	369	59	to	to	PART
ihlr-18810	369	60	be	be	AUX
ihlr-18810	369	61	implanted	implant	VERB
ihlr-18810	369	62	in	in	ADP
ihlr-18810	369	63	the	the	DET
ihlr-18810	369	64	body	body	NOUN
ihlr-18810	369	65	for	for	ADP
ihlr-18810	369	66	more	more	ADJ
ihlr-18810	369	67	than	than	ADP
ihlr-18810	369	68	one	one	NUM
ihlr-18810	369	69	year	year	NOUN
ihlr-18810	369	70	or	or	CCONJ
ihlr-18810	369	71	are	be	AUX
ihlr-18810	369	72	life	life	NOUN
ihlr-18810	369	73	-	-	PUNCT
ihlr-18810	369	74	sustaining	sustain	VERB
ihlr-18810	369	75	or	or	CCONJ
ihlr-18810	369	76	life	life	NOUN
ihlr-18810	369	77	-	-	PUNCT
ihlr-18810	369	78	supporting	support	VERB
ihlr-18810	369	79	devices	device	NOUN
ihlr-18810	369	80	used	use	VERB
ihlr-18810	369	81	outside	outside	ADP
ihlr-18810	369	82	of	of	ADP
ihlr-18810	369	83	a	a	DET
ihlr-18810	369	84	hospital	hospital	NOUN
ihlr-18810	369	85	facility	facility	NOUN
ihlr-18810	369	86	,	,	PUNCT
ihlr-18810	369	87	and	and	CCONJ
ihlr-18810	369	88	devices	device	NOUN
ihlr-18810	369	89	which	which	PRON
ihlr-18810	369	90	are	be	AUX
ihlr-18810	369	91	expected	expect	VERB
ihlr-18810	369	92	to	to	PART
ihlr-18810	369	93	have	have	VERB
ihlr-18810	369	94	significant	significant	ADJ
ihlr-18810	369	95	use	use	NOUN
ihlr-18810	369	96	in	in	ADP
ihlr-18810	369	97	pediatric	pediatric	ADJ
ihlr-18810	369	98	populations.141	populations.141	NOUN
ihlr-18810	369	99	manufacturers	manufacturer	NOUN
ihlr-18810	369	100	required	require	VERB
ihlr-18810	369	101	to	to	PART
ihlr-18810	369	102	conduct	conduct	VERB
ihlr-18810	369	103	this	this	DET
ihlr-18810	369	104	section	section	NOUN
ihlr-18810	369	105	522	522	NUM
ihlr-18810	369	106	surveillance	surveillance	NOUN
ihlr-18810	369	107	shall	shall	AUX
ihlr-18810	369	108	,	,	PUNCT
ihlr-18810	369	109	upon	upon	SCONJ
ihlr-18810	369	110	receipt	receipt	NOUN
ihlr-18810	369	111	of	of	ADP
ihlr-18810	369	112	the	the	DET
ihlr-18810	369	113	order	order	NOUN
ihlr-18810	369	114	,	,	PUNCT
ihlr-18810	369	115	have	have	VERB
ihlr-18810	369	116	thirty	thirty	NUM
ihlr-18810	369	117	days	day	NOUN
ihlr-18810	369	118	to	to	PART
ihlr-18810	369	119	submit	submit	VERB
ihlr-18810	369	120	a	a	DET
ihlr-18810	369	121	plain	plain	NOUN
ihlr-18810	369	122	for	for	ADP
ihlr-18810	369	123	the	the	DET
ihlr-18810	369	124	required	require	VERB
ihlr-18810	369	125	surveillance	surveillance	NOUN
ihlr-18810	369	126	,	,	PUNCT
ihlr-18810	369	127	which	which	PRON
ihlr-18810	369	128	the	the	DET
ihlr-18810	369	129	secretary	secretary	NOUN
ihlr-18810	369	130	of	of	ADP
ihlr-18810	369	131	hhs	hhs	PROPN
ihlr-18810	369	132	must	must	AUX
ihlr-18810	369	133	approve	approve	VERB
ihlr-18810	369	134	within	within	ADP
ihlr-18810	369	135	sixty	sixty	ADJ
ihlr-18810	369	136	days.142	days.142	NOUN
ihlr-18810	369	137	to	to	PART
ihlr-18810	369	138	be	be	AUX
ihlr-18810	369	139	approved	approve	VERB
ihlr-18810	369	140	,	,	PUNCT
ihlr-18810	369	141	the	the	DET
ihlr-18810	369	142	plan	plan	NOUN
ihlr-18810	369	143	must	must	AUX
ihlr-18810	369	144	effectively	effectively	ADV
ihlr-18810	369	145	facilitate	facilitate	VERB
ihlr-18810	369	146	the	the	DET
ihlr-18810	369	147	collection	collection	NOUN
ihlr-18810	369	148	of	of	ADP
ihlr-18810	369	149	data	datum	NOUN
ihlr-18810	369	150	useful	useful	ADJ
ihlr-18810	369	151	in	in	ADP
ihlr-18810	369	152	identifying	identify	VERB
ihlr-18810	369	153	previously	previously	ADV
ihlr-18810	369	154	unforeseen	unforeseen	ADJ
ihlr-18810	369	155	adverse	adverse	ADJ
ihlr-18810	369	156	events	event	NOUN
ihlr-18810	369	157	or	or	CCONJ
ihlr-18810	369	158	other	other	ADJ
ihlr-18810	369	159	similarly	similarly	ADV
ihlr-18810	369	160	helpful	helpful	ADJ
ihlr-18810	369	161	information.143	information.143	NOUN
ihlr-18810	369	162	generally	generally	ADV
ihlr-18810	369	163	,	,	PUNCT
ihlr-18810	369	164	these	these	DET
ihlr-18810	369	165	studies	study	NOUN
ihlr-18810	369	166	focus	focus	VERB
ihlr-18810	369	167	on	on	ADP
ihlr-18810	369	168	"	"	PUNCT
ihlr-18810	369	169	one	one	NUM
ihlr-18810	369	170	or	or	CCONJ
ihlr-18810	369	171	two	two	NUM
ihlr-18810	369	172	aspects	aspect	NOUN
ihlr-18810	369	173	of	of	ADP
ihlr-18810	369	174	performance	performance	NOUN
ihlr-18810	369	175	"	"	PUNCT
ihlr-18810	369	176	of	of	ADP
ihlr-18810	369	177	the	the	DET
ihlr-18810	369	178	device	device	NOUN
ihlr-18810	369	179	.	.	PUNCT
ihlr-18810	370	1	144	144	NUM
ihlr-18810	371	1	the	the	DET
ihlr-18810	371	2	surveillance	surveillance	NOUN
ihlr-18810	371	3	period	period	NOUN
ihlr-18810	371	4	may	may	AUX
ihlr-18810	371	5	be	be	AUX
ihlr-18810	371	6	ordered	order	VERB
ihlr-18810	371	7	to	to	PART
ihlr-18810	371	8	last	last	VERB
ihlr-18810	371	9	up	up	ADP
ihlr-18810	371	10	to	to	ADP
ihlr-18810	371	11	thirtysix	thirtysix	NOUN
ihlr-18810	371	12	months	month	NOUN
ihlr-18810	371	13	,	,	PUNCT
ihlr-18810	371	14	and	and	CCONJ
ihlr-18810	371	15	can	can	AUX
ihlr-18810	371	16	be	be	AUX
ihlr-18810	371	17	extended	extend	VERB
ihlr-18810	371	18	by	by	ADP
ihlr-18810	371	19	mutual	mutual	ADJ
ihlr-18810	371	20	agreement	agreement	NOUN
ihlr-18810	371	21	between	between	ADP
ihlr-18810	371	22	the	the	DET
ihlr-18810	371	23	manufacturer	manufacturer	NOUN
ihlr-18810	371	24	and	and	CCONJ
ihlr-18810	371	25	the	the	DET
ihlr-18810	371	26	secretary.145	secretary.145	NOUN
ihlr-18810	371	27	this	this	DET
ihlr-18810	371	28	time	time	NOUN
ihlr-18810	371	29	frame	frame	NOUN
ihlr-18810	371	30	is	be	AUX
ihlr-18810	371	31	too	too	ADV
ihlr-18810	371	32	short	short	ADJ
ihlr-18810	371	33	to	to	PART
ihlr-18810	371	34	enable	enable	VERB
ihlr-18810	371	35	the	the	DET
ihlr-18810	371	36	discovery	discovery	NOUN
ihlr-18810	371	37	,	,	PUNCT
ihlr-18810	371	38	through	through	ADP
ihlr-18810	371	39	these	these	DET
ihlr-18810	371	40	studies	study	NOUN
ihlr-18810	371	41	,	,	PUNCT
ihlr-18810	371	42	of	of	ADP
ihlr-18810	371	43	latent	latent	NOUN
ihlr-18810	371	44	safety	safety	NOUN
ihlr-18810	371	45	or	or	CCONJ
ihlr-18810	371	46	effectiveness	effectiveness	NOUN
ihlr-18810	371	47	problems	problem	NOUN
ihlr-18810	371	48	that	that	PRON
ihlr-18810	371	49	might	might	AUX
ihlr-18810	371	50	arise	arise	VERB
ihlr-18810	371	51	in	in	ADP
ihlr-18810	371	52	the	the	DET
ihlr-18810	371	53	use	use	NOUN
ihlr-18810	371	54	of	of	ADP
ihlr-18810	371	55	the	the	DET
ihlr-18810	371	56	device.146	device.146	PROPN
ihlr-18810	371	57	additionally	additionally	ADV
ihlr-18810	371	58	,	,	PUNCT
ihlr-18810	371	59	all	all	DET
ihlr-18810	371	60	critical	critical	ADJ
ihlr-18810	371	61	information	information	NOUN
ihlr-18810	371	62	gleaned	glean	VERB
ihlr-18810	371	63	from	from	ADP
ihlr-18810	371	64	the	the	DET
ihlr-18810	371	65	studies	study	NOUN
ihlr-18810	371	66	might	might	AUX
ihlr-18810	371	67	not	not	PART
ihlr-18810	371	68	be	be	AUX
ihlr-18810	371	69	required	require	VERB
ihlr-18810	371	70	to	to	PART
ihlr-18810	371	71	be	be	AUX
ihlr-18810	371	72	reported.147	reported.147	NOUN
ihlr-18810	371	73	140	140	NUM
ihlr-18810	371	74	federal	federal	ADJ
ihlr-18810	371	75	food	food	NOUN
ihlr-18810	371	76	,	,	PUNCT
ihlr-18810	371	77	drug	drug	NOUN
ihlr-18810	371	78	and	and	CCONJ
ihlr-18810	371	79	cosmetic	cosmetic	PROPN
ihlr-18810	371	80	act	act	NOUN
ihlr-18810	371	81	,	,	PUNCT
ihlr-18810	371	82	21	21	NUM
ihlr-18810	371	83	u.s.c	u.s.c	ADJ
ihlr-18810	371	84	.	.	PUNCT
ihlr-18810	372	1	§	§	PROPN
ihlr-18810	372	2	360i(a	360i(a	PROPN
ihlr-18810	372	3	)	)	PUNCT
ihlr-18810	372	4	(	(	PUNCT
ihlr-18810	372	5	2012	2012	NUM
ihlr-18810	372	6	)	)	PUNCT
ihlr-18810	372	7	.	.	PUNCT
ihlr-18810	373	1	141	141	NUM
ihlr-18810	374	1	i	i	PRON
ihlr-18810	374	2	d.	d.	PROPN
ihlr-18810	374	3	142	142	NUM
ihlr-18810	374	4	federal	federal	ADJ
ihlr-18810	374	5	food	food	NOUN
ihlr-18810	374	6	,	,	PUNCT
ihlr-18810	374	7	drug	drug	NOUN
ihlr-18810	374	8	and	and	CCONJ
ihlr-18810	374	9	cosmetic	cosmetic	PROPN
ihlr-18810	374	10	act	act	NOUN
ihlr-18810	374	11	,	,	PUNCT
ihlr-18810	374	12	21	21	NUM
ihlr-18810	374	13	u.s.c	u.s.c	ADJ
ihlr-18810	374	14	.	.	PUNCT
ihlr-18810	375	1	§	§	PROPN
ihlr-18810	375	2	360i(b	360i(b	NUM
ihlr-18810	375	3	)	)	PUNCT
ihlr-18810	375	4	(	(	PUNCT
ihlr-18810	375	5	2012	2012	NUM
ihlr-18810	375	6	)	)	PUNCT
ihlr-18810	375	7	.	.	PUNCT
ihlr-18810	376	1	143	143	NUM
ihlr-18810	377	1	[	[	X
ihlr-18810	377	2	d.	d.	NOUN
ihlr-18810	377	3	144	144	NUM
ihlr-18810	377	4	iom	iom	PROPN
ihlr-18810	377	5	report	report	PROPN
ihlr-18810	377	6	,	,	PUNCT
ihlr-18810	377	7	supra	supra	PROPN
ihlr-18810	377	8	note	note	NOUN
ihlr-18810	377	9	6	6	NUM
ihlr-18810	377	10	,	,	PUNCT
ihlr-18810	377	11	at	at	ADP
ihlr-18810	377	12	132	132	NUM
ihlr-18810	377	13	.	.	NOUN
ihlr-18810	377	14	145	145	NUM
ihlr-18810	377	15	federal	federal	ADJ
ihlr-18810	377	16	food	food	NOUN
ihlr-18810	377	17	,	,	PUNCT
ihlr-18810	377	18	drug	drug	NOUN
ihlr-18810	377	19	and	and	CCONJ
ihlr-18810	377	20	cosmetic	cosmetic	PROPN
ihlr-18810	377	21	act	act	NOUN
ihlr-18810	377	22	,	,	PUNCT
ihlr-18810	377	23	21	21	NUM
ihlr-18810	377	24	u.s.c	u.s.c	ADJ
ihlr-18810	377	25	.	.	PUNCT
ihlr-18810	378	1	§	§	PROPN
ihlr-18810	378	2	3601(b	3601(b	NUM
ihlr-18810	378	3	)	)	PUNCT
ihlr-18810	378	4	(	(	PUNCT
ihlr-18810	378	5	2012	2012	NUM
ihlr-18810	378	6	)	)	PUNCT
ihlr-18810	378	7	.	.	PUNCT
ihlr-18810	379	1	146	146	NUM
ihlr-18810	379	2	iom	iom	PROPN
ihlr-18810	379	3	report	report	NOUN
ihlr-18810	379	4	,	,	PUNCT
ihlr-18810	379	5	supra	supra	PROPN
ihlr-18810	379	6	note	note	NOUN
ihlr-18810	379	7	6	6	NUM
ihlr-18810	379	8	,	,	PUNCT
ihlr-18810	379	9	at	at	ADP
ihlr-18810	379	10	132	132	NUM
ihlr-18810	379	11	.	.	PUNCT
ihlr-18810	380	1	147	147	NUM
ihlr-18810	380	2	i	i	NOUN
ihlr-18810	380	3	d	d	PROPN
ihlr-18810	380	4	2013	2013	NUM
ihlr-18810	380	5	141	141	NUM
ihlr-18810	380	6	indiana	indiana	PROPN
ihlr-18810	380	7	health	health	PROPN
ihlr-18810	380	8	law	law	PROPN
ihlr-18810	380	9	review	review	NOUN
ihlr-18810	380	10	3	3	NUM
ihlr-18810	380	11	.	.	PUNCT
ihlr-18810	381	1	enforcement	enforcement	NOUN
ihlr-18810	381	2	powers	power	NOUN
ihlr-18810	381	3	a.	a.	PROPN
ihlr-18810	381	4	administrative	administrative	ADJ
ihlr-18810	381	5	while	while	SCONJ
ihlr-18810	381	6	there	there	PRON
ihlr-18810	381	7	are	be	VERB
ihlr-18810	381	8	many	many	ADJ
ihlr-18810	381	9	regulations	regulation	NOUN
ihlr-18810	381	10	in	in	ADP
ihlr-18810	381	11	place	place	NOUN
ihlr-18810	381	12	governing	govern	VERB
ihlr-18810	381	13	medical	medical	ADJ
ihlr-18810	381	14	devices	device	NOUN
ihlr-18810	381	15	,	,	PUNCT
ihlr-18810	381	16	their	their	PRON
ihlr-18810	381	17	ability	ability	NOUN
ihlr-18810	381	18	to	to	PART
ihlr-18810	381	19	protect	protect	VERB
ihlr-18810	381	20	patients	patient	NOUN
ihlr-18810	381	21	will	will	AUX
ihlr-18810	381	22	depend	depend	VERB
ihlr-18810	381	23	upon	upon	SCONJ
ihlr-18810	381	24	the	the	DET
ihlr-18810	381	25	extent	extent	NOUN
ihlr-18810	381	26	to	to	PART
ihlr-18810	381	27	which	which	PRON
ihlr-18810	381	28	the	the	DET
ihlr-18810	381	29	regulations	regulation	NOUN
ihlr-18810	381	30	can	can	AUX
ihlr-18810	381	31	be	be	AUX
ihlr-18810	381	32	enforced	enforce	VERB
ihlr-18810	381	33	.	.	PUNCT
ihlr-18810	382	1	when	when	SCONJ
ihlr-18810	382	2	there	there	PRON
ihlr-18810	382	3	is	be	VERB
ihlr-18810	382	4	a	a	DET
ihlr-18810	382	5	problem	problem	NOUN
ihlr-18810	382	6	with	with	ADP
ihlr-18810	382	7	the	the	DET
ihlr-18810	382	8	safety	safety	NOUN
ihlr-18810	382	9	or	or	CCONJ
ihlr-18810	382	10	efficacy	efficacy	NOUN
ihlr-18810	382	11	of	of	ADP
ihlr-18810	382	12	a	a	DET
ihlr-18810	382	13	device	device	NOUN
ihlr-18810	382	14	,	,	PUNCT
ihlr-18810	382	15	the	the	DET
ihlr-18810	382	16	fda	fda	PROPN
ihlr-18810	382	17	first	first	ADV
ihlr-18810	382	18	seeks	seek	VERB
ihlr-18810	382	19	to	to	PART
ihlr-18810	382	20	work	work	VERB
ihlr-18810	382	21	with	with	ADP
ihlr-18810	382	22	the	the	DET
ihlr-18810	382	23	manufacturer	manufacturer	NOUN
ihlr-18810	382	24	to	to	PART
ihlr-18810	382	25	correct	correct	VERB
ihlr-18810	382	26	the	the	DET
ihlr-18810	382	27	problem	problem	NOUN
ihlr-18810	382	28	voluntarily	voluntarily	ADV
ihlr-18810	382	29	.	.	PUNCT
ihlr-18810	383	1	in	in	ADP
ihlr-18810	383	2	an	an	DET
ihlr-18810	383	3	effort	effort	NOUN
ihlr-18810	383	4	to	to	PART
ihlr-18810	383	5	obtain	obtain	VERB
ihlr-18810	383	6	voluntary	voluntary	ADJ
ihlr-18810	383	7	compliance	compliance	NOUN
ihlr-18810	383	8	with	with	ADP
ihlr-18810	383	9	a	a	DET
ihlr-18810	383	10	request	request	NOUN
ihlr-18810	383	11	the	the	DET
ihlr-18810	383	12	agency	agency	NOUN
ihlr-18810	383	13	can	can	AUX
ihlr-18810	383	14	not	not	PART
ihlr-18810	383	15	directly	directly	ADV
ihlr-18810	383	16	impose	impose	VERB
ihlr-18810	383	17	on	on	ADP
ihlr-18810	383	18	a	a	DET
ihlr-18810	383	19	manufacturer	manufacturer	NOUN
ihlr-18810	383	20	,	,	PUNCT
ihlr-18810	383	21	the	the	DET
ihlr-18810	383	22	fda	fda	PROPN
ihlr-18810	383	23	may	may	AUX
ihlr-18810	383	24	threaten	threaten	VERB
ihlr-18810	383	25	to	to	PART
ihlr-18810	383	26	withhold	withhold	VERB
ihlr-18810	383	27	a	a	DET
ihlr-18810	383	28	benefit	benefit	NOUN
ihlr-18810	383	29	or	or	CCONJ
ihlr-18810	383	30	impose	impose	VERB
ihlr-18810	383	31	a	a	DET
ihlr-18810	383	32	sanction	sanction	NOUN
ihlr-18810	383	33	in	in	ADP
ihlr-18810	383	34	an	an	DET
ihlr-18810	383	35	effort	effort	NOUN
ihlr-18810	383	36	to	to	PART
ihlr-18810	383	37	encourage	encourage	VERB
ihlr-18810	383	38	compliance.148	compliance.148	NOUN
ihlr-18810	383	39	if	if	SCONJ
ihlr-18810	383	40	the	the	DET
ihlr-18810	383	41	manufacturer	manufacturer	NOUN
ihlr-18810	383	42	is	be	AUX
ihlr-18810	383	43	unwilling	unwilling	ADJ
ihlr-18810	383	44	,	,	PUNCT
ihlr-18810	383	45	the	the	DET
ihlr-18810	383	46	fda	fda	PROPN
ihlr-18810	383	47	has	have	VERB
ihlr-18810	383	48	a	a	DET
ihlr-18810	383	49	number	number	NOUN
ihlr-18810	383	50	of	of	ADP
ihlr-18810	383	51	legal	legal	ADJ
ihlr-18810	383	52	remedies	remedy	NOUN
ihlr-18810	383	53	available	available	ADJ
ihlr-18810	383	54	to	to	PART
ihlr-18810	383	55	use	use	VERB
ihlr-18810	383	56	in	in	ADP
ihlr-18810	383	57	the	the	DET
ihlr-18810	383	58	enforcement	enforcement	NOUN
ihlr-18810	383	59	of	of	ADP
ihlr-18810	383	60	its	its	PRON
ihlr-18810	383	61	regulations	regulation	NOUN
ihlr-18810	383	62	,	,	PUNCT
ihlr-18810	383	63	including	include	VERB
ihlr-18810	383	64	recalling	recall	VERB
ihlr-18810	383	65	the	the	DET
ihlr-18810	383	66	device	device	NOUN
ihlr-18810	383	67	,	,	PUNCT
ihlr-18810	383	68	seizure	seizure	NOUN
ihlr-18810	383	69	of	of	ADP
ihlr-18810	383	70	the	the	DET
ihlr-18810	383	71	device	device	NOUN
ihlr-18810	383	72	by	by	ADP
ihlr-18810	383	73	federal	federal	ADJ
ihlr-18810	383	74	marshals	marshal	NOUN
ihlr-18810	383	75	,	,	PUNCT
ihlr-18810	383	76	or	or	CCONJ
ihlr-18810	383	77	,	,	PUNCT
ihlr-18810	383	78	for	for	ADP
ihlr-18810	383	79	imported	import	VERB
ihlr-18810	383	80	devices	device	NOUN
ihlr-18810	383	81	,	,	PUNCT
ihlr-18810	383	82	detainment	detainment	NOUN
ihlr-18810	383	83	at	at	ADP
ihlr-18810	383	84	the	the	DET
ihlr-18810	383	85	port	port	NOUN
ihlr-18810	383	86	of	of	ADP
ihlr-18810	383	87	entry.149	entry.149	NOUN
ihlr-18810	383	88	when	when	SCONJ
ihlr-18810	383	89	a	a	DET
ihlr-18810	383	90	regulation	regulation	NOUN
ihlr-18810	383	91	governing	govern	VERB
ihlr-18810	383	92	medical	medical	ADJ
ihlr-18810	383	93	devices	device	NOUN
ihlr-18810	383	94	is	be	AUX
ihlr-18810	383	95	violated	violate	VERB
ihlr-18810	383	96	,	,	PUNCT
ihlr-18810	383	97	the	the	DET
ihlr-18810	383	98	first	first	ADJ
ihlr-18810	383	99	contact	contact	NOUN
ihlr-18810	383	100	from	from	ADP
ihlr-18810	383	101	the	the	DET
ihlr-18810	383	102	fda	fda	PROPN
ihlr-18810	383	103	is	be	AUX
ihlr-18810	383	104	often	often	ADV
ihlr-18810	383	105	a	a	DET
ihlr-18810	383	106	warning	warning	NOUN
ihlr-18810	383	107	letter	letter	NOUN
ihlr-18810	383	108	to	to	ADP
ihlr-18810	383	109	the	the	DET
ihlr-18810	383	110	responsible	responsible	ADJ
ihlr-18810	383	111	individual	individual	NOUN
ihlr-18810	383	112	or	or	CCONJ
ihlr-18810	383	113	entity	entity	NOUN
ihlr-18810	383	114	,	,	PUNCT
ihlr-18810	383	115	instructing	instruct	VERB
ihlr-18810	383	116	the	the	DET
ihlr-18810	383	117	recipient	recipient	NOUN
ihlr-18810	383	118	to	to	PART
ihlr-18810	383	119	take	take	VERB
ihlr-18810	383	120	prompt	prompt	ADJ
ihlr-18810	383	121	action	action	NOUN
ihlr-18810	383	122	to	to	PART
ihlr-18810	383	123	correct	correct	VERB
ihlr-18810	383	124	the	the	DET
ihlr-18810	383	125	violation.150	violation.150	PROPN
ihlr-18810	383	126	"	"	PUNCT
ihlr-18810	383	127	warning	warning	NOUN
ihlr-18810	383	128	letters	letter	NOUN
ihlr-18810	383	129	are	be	AUX
ihlr-18810	383	130	informal	informal	ADJ
ihlr-18810	383	131	and	and	CCONJ
ihlr-18810	383	132	advisory	advisory	ADJ
ihlr-18810	383	133	but	but	CCONJ
ihlr-18810	383	134	are	be	AUX
ihlr-18810	383	135	available	available	ADJ
ihlr-18810	383	136	to	to	ADP
ihlr-18810	383	137	the	the	DET
ihlr-18810	383	138	public	public	NOUN
ihlr-18810	383	139	on	on	ADP
ihlr-18810	383	140	the	the	DET
ihlr-18810	383	141	fda	fda	PROPN
ihlr-18810	383	142	's	's	PART
ihlr-18810	383	143	website	website	NOUN
ihlr-18810	383	144	.	.	PUNCT
ihlr-18810	384	1	"151	"151	PROPN
ihlr-18810	384	2	the	the	DET
ihlr-18810	384	3	effect	effect	NOUN
ihlr-18810	384	4	of	of	ADP
ihlr-18810	384	5	such	such	DET
ihlr-18810	384	6	a	a	DET
ihlr-18810	384	7	letter	letter	NOUN
ihlr-18810	384	8	varies	vary	VERB
ihlr-18810	384	9	depending	depend	VERB
ihlr-18810	384	10	on	on	ADP
ihlr-18810	384	11	the	the	DET
ihlr-18810	384	12	type	type	NOUN
ihlr-18810	384	13	of	of	ADP
ihlr-18810	384	14	approval	approval	NOUN
ihlr-18810	384	15	sought	seek	VERB
ihlr-18810	384	16	for	for	ADP
ihlr-18810	384	17	the	the	DET
ihlr-18810	384	18	device	device	NOUN
ihlr-18810	384	19	.	.	PUNCT
ihlr-18810	385	1	however	however	ADV
ihlr-18810	385	2	,	,	PUNCT
ihlr-18810	385	3	devices	device	NOUN
ihlr-18810	385	4	seeking	seek	VERB
ihlr-18810	385	5	510(k	510(k	NUM
ihlr-18810	385	6	)	)	PUNCT
ihlr-18810	385	7	clearance	clearance	NOUN
ihlr-18810	385	8	generally	generally	ADV
ihlr-18810	385	9	can	can	AUX
ihlr-18810	385	10	not	not	PART
ihlr-18810	385	11	be	be	AUX
ihlr-18810	385	12	blocked	block	VERB
ihlr-18810	385	13	by	by	ADP
ihlr-18810	385	14	a	a	DET
ihlr-18810	385	15	warn	warn	VERB
ihlr-18810	385	16	-	-	PUNCT
ihlr-18810	385	17	ing	ing	ADJ
ihlr-18810	385	18	letter	letter	NOUN
ihlr-18810	385	19	unless	unless	SCONJ
ihlr-18810	385	20	there	there	PRON
ihlr-18810	385	21	is	be	VERB
ihlr-18810	385	22	a	a	DET
ihlr-18810	385	23	"	"	PUNCT
ihlr-18810	385	24	substantial	substantial	ADJ
ihlr-18810	385	25	likelihood	likelihood	NOUN
ihlr-18810	385	26	"	"	PUNCT
ihlr-18810	385	27	of	of	ADP
ihlr-18810	385	28	a	a	DET
ihlr-18810	385	29	serious	serious	ADJ
ihlr-18810	385	30	risk	risk	NOUN
ihlr-18810	385	31	of	of	ADP
ihlr-18810	385	32	health	health	NOUN
ihlr-18810	385	33	from	from	ADP
ihlr-18810	385	34	the	the	DET
ihlr-18810	385	35	device	device	NOUN
ihlr-18810	385	36	because	because	SCONJ
ihlr-18810	385	37	of	of	ADP
ihlr-18810	385	38	a	a	DET
ihlr-18810	385	39	specific	specific	ADJ
ihlr-18810	385	40	gmp	gmp	PROPN
ihlr-18810	385	41	violation	violation	NOUN
ihlr-18810	385	42	.	.	PUNCT
ihlr-18810	386	1	152	152	NUM
ihlr-18810	386	2	in	in	ADP
ihlr-18810	386	3	fiscal	fiscal	ADJ
ihlr-18810	386	4	year	year	NOUN
ihlr-18810	386	5	2011	2011	NUM
ihlr-18810	386	6	,	,	PUNCT
ihlr-18810	386	7	the	the	DET
ihlr-18810	386	8	fda	fda	PROPN
ihlr-18810	386	9	's	's	PART
ihlr-18810	386	10	center	center	NOUN
ihlr-18810	386	11	for	for	ADP
ihlr-18810	386	12	devices	device	NOUN
ihlr-18810	386	13	and	and	CCONJ
ihlr-18810	386	14	radiological	radiological	ADJ
ihlr-18810	386	15	health	health	NOUN
ihlr-18810	386	16	issued	issue	VERB
ihlr-18810	386	17	175	175	NUM
ihlr-18810	386	18	warning	warning	NOUN
ihlr-18810	386	19	letters.153	letters.153	VERB
ihlr-18810	386	20	148	148	NUM
ihlr-18810	386	21	noah	noah	NOUN
ihlr-18810	386	22	,	,	PUNCT
ihlr-18810	386	23	supra	supra	PROPN
ihlr-18810	386	24	note	note	PROPN
ihlr-18810	386	25	88	88	NUM
ihlr-18810	386	26	,	,	PUNCT
ihlr-18810	386	27	at	at	ADP
ihlr-18810	386	28	906	906	NUM
ihlr-18810	386	29	.	.	NOUN
ihlr-18810	386	30	149	149	NUM
ihlr-18810	386	31	iom	iom	PROPN
ihlr-18810	386	32	report	report	NOUN
ihlr-18810	386	33	,	,	PUNCT
ihlr-18810	386	34	supra	supra	PROPN
ihlr-18810	386	35	note	note	NOUN
ihlr-18810	386	36	6	6	NUM
ihlr-18810	386	37	,	,	PUNCT
ihlr-18810	386	38	at	at	ADP
ihlr-18810	386	39	133	133	NUM
ihlr-18810	386	40	.	.	PUNCT
ihlr-18810	387	1	150	150	NUM
ihlr-18810	388	1	i	i	PRON
ihlr-18810	388	2	d.	d.	NOUN
ihlr-18810	388	3	at	at	ADP
ihlr-18810	388	4	134	134	NUM
ihlr-18810	388	5	.	.	PUNCT
ihlr-18810	389	1	151	151	NUM
ihlr-18810	389	2	i	i	NOUN
ihlr-18810	389	3	d	d	PROPN
ihlr-18810	389	4	152	152	NUM
ihlr-18810	390	1	i	i	PROPN
ihlr-18810	390	2	d.	d.	PROPN
ihlr-18810	390	3	153	153	NUM
ihlr-18810	390	4	warning	warning	NOUN
ihlr-18810	390	5	letters	letter	NOUN
ihlr-18810	390	6	by	by	ADP
ihlr-18810	390	7	fda	fda	PROPN
ihlr-18810	390	8	center	center	PROPN
ihlr-18810	390	9	fscal	fscal	ADJ
ihlr-18810	390	10	year	year	NOUN
ihlr-18810	390	11	2011	2011	NUM
ihlr-18810	390	12	,	,	PUNCT
ihlr-18810	390	13	fda.gov	fda.gov	NUM
ihlr-18810	390	14	,	,	PUNCT
ihlr-18810	390	15	http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781	http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781	PROPN
ihlr-18810	390	16	.	.	PUNCT
ihlr-18810	390	17	pdf	pdf	NOUN
ihlr-18810	390	18	.	.	PUNCT
ihlr-18810	391	1	vol	vol	NOUN
ihlr-18810	391	2	.	.	PUNCT
ihlr-18810	392	1	10:1142	10:1142	NUM
ihlr-18810	392	2	510(k	510(k	X
ihlr-18810	392	3	)	)	PUNCT
ihlr-18810	392	4	clearance	clearance	NOUN
ihlr-18810	392	5	the	the	DET
ihlr-18810	392	6	fda	fda	PROPN
ihlr-18810	392	7	defines	define	VERB
ihlr-18810	392	8	a	a	DET
ihlr-18810	392	9	recall	recall	NOUN
ihlr-18810	392	10	as	as	ADP
ihlr-18810	392	11	"	"	PUNCT
ihlr-18810	392	12	the	the	DET
ihlr-18810	392	13	correction	correction	NOUN
ihlr-18810	392	14	or	or	CCONJ
ihlr-18810	392	15	removal	removal	NOUN
ihlr-18810	392	16	of	of	ADP
ihlr-18810	392	17	a	a	DET
ihlr-18810	392	18	device	device	NOUN
ihlr-18810	392	19	for	for	ADP
ihlr-18810	392	20	human	human	ADJ
ihlr-18810	392	21	use	use	NOUN
ihlr-18810	392	22	where	where	SCONJ
ihlr-18810	392	23	fda	fda	PROPN
ihlr-18810	392	24	finds	find	VERB
ihlr-18810	392	25	that	that	SCONJ
ihlr-18810	392	26	there	there	PRON
ihlr-18810	392	27	is	be	VERB
ihlr-18810	392	28	a	a	DET
ihlr-18810	392	29	reasonable	reasonable	ADJ
ihlr-18810	392	30	probability	probability	NOUN
ihlr-18810	392	31	that	that	SCONJ
ihlr-18810	392	32	the	the	DET
ihlr-18810	392	33	device	device	NOUN
ihlr-18810	392	34	would	would	AUX
ihlr-18810	392	35	cause	cause	VERB
ihlr-18810	392	36	serious	serious	ADJ
ihlr-18810	392	37	,	,	PUNCT
ihlr-18810	392	38	adverse	adverse	ADJ
ihlr-18810	392	39	health	health	NOUN
ihlr-18810	392	40	consequences	consequence	NOUN
ihlr-18810	392	41	or	or	CCONJ
ihlr-18810	392	42	death	death	NOUN
ihlr-18810	392	43	.	.	PUNCT
ihlr-18810	393	1	"154	"154	PROPN
ihlr-18810	393	2	recalls	recall	VERB
ihlr-18810	393	3	are	be	AUX
ihlr-18810	393	4	usually	usually	ADV
ihlr-18810	393	5	voluntary	voluntary	ADJ
ihlr-18810	393	6	,	,	PUNCT
ihlr-18810	393	7	and	and	CCONJ
ihlr-18810	393	8	are	be	AUX
ihlr-18810	393	9	undertaken	undertake	VERB
ihlr-18810	393	10	by	by	ADP
ihlr-18810	393	11	manufacturers	manufacturer	NOUN
ihlr-18810	393	12	and	and	CCONJ
ihlr-18810	393	13	distributers	distributer	NOUN
ihlr-18810	393	14	in	in	ADP
ihlr-18810	393	15	an	an	DET
ihlr-18810	393	16	effort	effort	NOUN
ihlr-18810	393	17	to	to	PART
ihlr-18810	393	18	carry	carry	VERB
ihlr-18810	393	19	out	out	ADP
ihlr-18810	393	20	their	their	PRON
ihlr-18810	393	21	responsibilities	responsibility	NOUN
ihlr-18810	393	22	to	to	PART
ihlr-18810	393	23	protect	protect	VERB
ihlr-18810	393	24	the	the	DET
ihlr-18810	393	25	public	public	NOUN
ihlr-18810	393	26	from	from	ADP
ihlr-18810	393	27	a	a	DET
ihlr-18810	393	28	risk	risk	NOUN
ihlr-18810	393	29	of	of	ADP
ihlr-18810	393	30	injury	injury	NOUN
ihlr-18810	393	31	from	from	ADP
ihlr-18810	393	32	their	their	PRON
ihlr-18810	393	33	product(s	product(s	NOUN
ihlr-18810	393	34	)	)	PUNCT
ihlr-18810	393	35	as	as	ADP
ihlr-18810	393	36	an	an	DET
ihlr-18810	393	37	alternative	alternative	NOUN
ihlr-18810	393	38	to	to	ADP
ihlr-18810	393	39	an	an	DET
ihlr-18810	393	40	fda	fda	PROPN
ihlr-18810	393	41	initiated	initiate	VERB
ihlr-18810	393	42	seizure	seizure	NOUN
ihlr-18810	393	43	or	or	CCONJ
ihlr-18810	393	44	other	other	ADJ
ihlr-18810	393	45	court	court	NOUN
ihlr-18810	393	46	action.155	action.155	AUX
ihlr-18810	393	47	recalls	recall	NOUN
ihlr-18810	393	48	include	include	VERB
ihlr-18810	393	49	not	not	PART
ihlr-18810	393	50	only	only	ADV
ihlr-18810	393	51	a	a	DET
ihlr-18810	393	52	request	request	NOUN
ihlr-18810	393	53	for	for	ADP
ihlr-18810	393	54	the	the	DET
ihlr-18810	393	55	return	return	NOUN
ihlr-18810	393	56	of	of	ADP
ihlr-18810	393	57	the	the	DET
ihlr-18810	393	58	product	product	NOUN
ihlr-18810	393	59	,	,	PUNCT
ihlr-18810	393	60	but	but	CCONJ
ihlr-18810	393	61	also	also	ADV
ihlr-18810	393	62	any	any	DET
ihlr-18810	393	63	measures	measure	NOUN
ihlr-18810	393	64	taken	take	VERB
ihlr-18810	393	65	to	to	PART
ihlr-18810	393	66	correct	correct	VERB
ihlr-18810	393	67	any	any	DET
ihlr-18810	393	68	unsafe	unsafe	ADJ
ihlr-18810	393	69	features	feature	NOUN
ihlr-18810	393	70	of	of	ADP
ihlr-18810	393	71	the	the	DET
ihlr-18810	393	72	device	device	NOUN
ihlr-18810	393	73	,	,	PUNCT
ihlr-18810	393	74	such	such	ADJ
ihlr-18810	393	75	as	as	ADP
ihlr-18810	393	76	software	software	NOUN
ihlr-18810	393	77	patches	patch	NOUN
ihlr-18810	393	78	,	,	PUNCT
ihlr-18810	393	79	placing	place	VERB
ihlr-18810	393	80	stickers	sticker	NOUN
ihlr-18810	393	81	on	on	ADP
ihlr-18810	393	82	packaging	packaging	NOUN
ihlr-18810	393	83	,	,	PUNCT
ihlr-18810	393	84	revisions	revision	NOUN
ihlr-18810	393	85	of	of	ADP
ihlr-18810	393	86	labeling	labeling	NOUN
ihlr-18810	393	87	(	(	PUNCT
ihlr-18810	393	88	adding	add	VERB
ihlr-18810	393	89	warnings	warning	NOUN
ihlr-18810	393	90	or	or	CCONJ
ihlr-18810	393	91	clarifying	clarify	VERB
ihlr-18810	393	92	instructions	instruction	NOUN
ihlr-18810	393	93	)	)	PUNCT
ihlr-18810	393	94	,	,	PUNCT
ihlr-18810	393	95	informational	informational	ADJ
ihlr-18810	393	96	letters	letter	NOUN
ihlr-18810	393	97	,	,	PUNCT
ihlr-18810	393	98	and	and	CCONJ
ihlr-18810	393	99	servicing	servicing	NOUN
ihlr-18810	393	100	in	in	ADP
ihlr-18810	393	101	the	the	DET
ihlr-18810	393	102	field.156	field.156	NOUN
ihlr-18810	393	103	additionally	additionally	ADV
ihlr-18810	393	104	,	,	PUNCT
ihlr-18810	393	105	manufacturers	manufacturer	NOUN
ihlr-18810	393	106	and	and	CCONJ
ihlr-18810	393	107	importers	importer	NOUN
ihlr-18810	393	108	are	be	AUX
ihlr-18810	393	109	required	require	VERB
ihlr-18810	393	110	to	to	PART
ihlr-18810	393	111	report	report	VERB
ihlr-18810	393	112	to	to	ADP
ihlr-18810	393	113	the	the	DET
ihlr-18810	393	114	fda	fda	PROPN
ihlr-18810	393	115	any	any	DET
ihlr-18810	393	116	voluntary	voluntary	ADJ
ihlr-18810	393	117	corrections	correction	NOUN
ihlr-18810	393	118	or	or	CCONJ
ihlr-18810	393	119	removals	removal	NOUN
ihlr-18810	393	120	they	they	PRON
ihlr-18810	393	121	take	take	VERB
ihlr-18810	393	122	to	to	PART
ihlr-18810	393	123	reduce	reduce	VERB
ihlr-18810	393	124	a	a	DET
ihlr-18810	393	125	health	health	NOUN
ihlr-18810	393	126	risk	risk	NOUN
ihlr-18810	393	127	posed	pose	VERB
ihlr-18810	393	128	by	by	ADP
ihlr-18810	393	129	a	a	DET
ihlr-18810	393	130	device	device	NOUN
ihlr-18810	393	131	.	.	PUNCT
ihlr-18810	394	1	15	15	NUM
ihlr-18810	394	2	7	7	NUM
ihlr-18810	394	3	the	the	DET
ihlr-18810	394	4	fda	fda	PROPN
ihlr-18810	394	5	classifies	classify	VERB
ihlr-18810	394	6	recalls	recall	VERB
ihlr-18810	394	7	"	"	PUNCT
ihlr-18810	394	8	according	accord	VERB
ihlr-18810	394	9	to	to	ADP
ihlr-18810	394	10	the	the	DET
ihlr-18810	394	11	degree	degree	NOUN
ihlr-18810	394	12	of	of	ADP
ihlr-18810	394	13	hazard	hazard	NOUN
ihlr-18810	394	14	"	"	PUNCT
ihlr-18810	394	15	posed	pose	VERB
ihlr-18810	394	16	by	by	ADP
ihlr-18810	394	17	the	the	DET
ihlr-18810	394	18	device.158	device.158	PROPN
ihlr-18810	394	19	the	the	DET
ihlr-18810	394	20	most	most	ADV
ihlr-18810	394	21	serious	serious	ADJ
ihlr-18810	394	22	recalls	recall	NOUN
ihlr-18810	394	23	,	,	PUNCT
ihlr-18810	394	24	class	class	NOUN
ihlr-18810	394	25	i	i	PROPN
ihlr-18810	394	26	,	,	PUNCT
ihlr-18810	394	27	are	be	AUX
ihlr-18810	394	28	reserved	reserve	VERB
ihlr-18810	394	29	for	for	ADP
ihlr-18810	394	30	situations	situation	NOUN
ihlr-18810	394	31	where	where	SCONJ
ihlr-18810	394	32	there	there	PRON
ihlr-18810	394	33	is	be	VERB
ihlr-18810	394	34	a	a	DET
ihlr-18810	394	35	"	"	PUNCT
ihlr-18810	394	36	reasonable	reasonable	ADJ
ihlr-18810	394	37	probability	probability	NOUN
ihlr-18810	394	38	that	that	SCONJ
ihlr-18810	394	39	use	use	NOUN
ihlr-18810	394	40	of	of	ADP
ihlr-18810	394	41	or	or	CCONJ
ihlr-18810	394	42	exposure	exposure	NOUN
ihlr-18810	394	43	to	to	ADP
ihlr-18810	394	44	a	a	DET
ihlr-18810	394	45	violative	violative	ADJ
ihlr-18810	394	46	product	product	NOUN
ihlr-18810	394	47	will	will	AUX
ihlr-18810	394	48	cause	cause	VERB
ihlr-18810	394	49	serious	serious	ADJ
ihlr-18810	394	50	adverse	adverse	ADJ
ihlr-18810	394	51	health	health	NOUN
ihlr-18810	394	52	consequences	consequence	NOUN
ihlr-18810	394	53	or	or	CCONJ
ihlr-18810	394	54	death	death	NOUN
ihlr-18810	394	55	.	.	PUNCT
ihlr-18810	395	1	"159	"159	PROPN
ihlr-18810	395	2	class	class	PROPN
ihlr-18810	395	3	ii	ii	PROPN
ihlr-18810	395	4	recalls	recall	VERB
ihlr-18810	395	5	are	be	AUX
ihlr-18810	395	6	the	the	DET
ihlr-18810	395	7	most	most	ADV
ihlr-18810	395	8	common	common	ADJ
ihlr-18810	395	9	,	,	PUNCT
ihlr-18810	395	10	and	and	CCONJ
ihlr-18810	395	11	are	be	AUX
ihlr-18810	395	12	used	use	VERB
ihlr-18810	395	13	when	when	SCONJ
ihlr-18810	395	14	a	a	DET
ihlr-18810	395	15	product	product	NOUN
ihlr-18810	395	16	may	may	AUX
ihlr-18810	395	17	cause	cause	VERB
ihlr-18810	395	18	temporary	temporary	ADJ
ihlr-18810	395	19	adverse	adverse	ADJ
ihlr-18810	395	20	effects	effect	NOUN
ihlr-18810	395	21	,	,	PUNCT
ihlr-18810	395	22	but	but	CCONJ
ihlr-18810	395	23	in	in	ADP
ihlr-18810	395	24	which	which	PRON
ihlr-18810	395	25	there	there	PRON
ihlr-18810	395	26	is	be	VERB
ihlr-18810	395	27	a	a	DET
ihlr-18810	395	28	remote	remote	ADJ
ihlr-18810	395	29	possibility	possibility	NOUN
ihlr-18810	395	30	of	of	ADP
ihlr-18810	395	31	irreversible	irreversible	ADJ
ihlr-18810	395	32	consequences	consequence	NOUN
ihlr-18810	395	33	.	.	PUNCT
ihlr-18810	396	1	160	160	NUM
ihlr-18810	396	2	class	class	NOUN
ihlr-18810	396	3	iii	iii	NOUN
ihlr-18810	396	4	recalls	recall	VERB
ihlr-18810	396	5	are	be	AUX
ihlr-18810	396	6	used	use	VERB
ihlr-18810	396	7	when	when	SCONJ
ihlr-18810	396	8	the	the	DET
ihlr-18810	396	9	use	use	NOUN
ihlr-18810	396	10	of	of	ADP
ihlr-18810	396	11	a	a	DET
ihlr-18810	396	12	product	product	NOUN
ihlr-18810	396	13	is	be	AUX
ihlr-18810	396	14	not	not	PART
ihlr-18810	396	15	likely	likely	ADJ
ihlr-18810	396	16	to	to	PART
ihlr-18810	396	17	cause	cause	VERB
ihlr-18810	396	18	adverse	adverse	ADJ
ihlr-18810	396	19	consequences	consequence	NOUN
ihlr-18810	396	20	,	,	PUNCT
ihlr-18810	396	21	but	but	CCONJ
ihlr-18810	396	22	for	for	ADP
ihlr-18810	396	23	which	which	PRON
ihlr-18810	396	24	there	there	PRON
ihlr-18810	396	25	is	be	VERB
ihlr-18810	396	26	enough	enough	ADJ
ihlr-18810	396	27	likelihood	likelihood	NOUN
ihlr-18810	396	28	to	to	PART
ihlr-18810	396	29	justify	justify	VERB
ihlr-18810	396	30	a	a	DET
ihlr-18810	396	31	recall.11	recall.11	NOUN
ihlr-18810	396	32	although	although	SCONJ
ihlr-18810	396	33	recalls	recall	VERB
ihlr-18810	396	34	can	can	AUX
ihlr-18810	396	35	be	be	AUX
ihlr-18810	396	36	helpful	helpful	ADJ
ihlr-18810	396	37	in	in	ADP
ihlr-18810	396	38	providing	provide	VERB
ihlr-18810	396	39	information	information	NOUN
ihlr-18810	396	40	regarding	regard	VERB
ihlr-18810	396	41	signs	sign	NOUN
ihlr-18810	396	42	of	of	ADP
ihlr-18810	396	43	device	device	NOUN
ihlr-18810	396	44	safety	safety	NOUN
ihlr-18810	396	45	,	,	PUNCT
ihlr-18810	396	46	as	as	ADV
ihlr-18810	396	47	well	well	ADV
ihlr-18810	396	48	as	as	ADP
ihlr-18810	396	49	the	the	DET
ihlr-18810	396	50	point	point	NOUN
ihlr-18810	396	51	in	in	ADP
ihlr-18810	396	52	a	a	DET
ihlr-18810	396	53	154	154	NUM
ihlr-18810	396	54	21	21	NUM
ihlr-18810	396	55	c.f.r	c.f.r	NOUN
ihlr-18810	396	56	.	.	PUNCT
ihlr-18810	397	1	§	§	PROPN
ihlr-18810	397	2	810.2(j	810.2(j	PROPN
ihlr-18810	397	3	)	)	PUNCT
ihlr-18810	397	4	(	(	PUNCT
ihlr-18810	397	5	2012	2012	NUM
ihlr-18810	397	6	)	)	PUNCT
ihlr-18810	397	7	.	.	PUNCT
ihlr-18810	398	1	155	155	NUM
ihlr-18810	398	2	21	21	NUM
ihlr-18810	398	3	c.f.r	c.f.r	NOUN
ihlr-18810	398	4	.	.	PUNCT
ihlr-18810	399	1	§	§	PROPN
ihlr-18810	399	2	7.40	7.40	NUM
ihlr-18810	399	3	(	(	PUNCT
ihlr-18810	399	4	2012	2012	NUM
ihlr-18810	399	5	)	)	PUNCT
ihlr-18810	399	6	.	.	PUNCT
ihlr-18810	400	1	156	156	NUM
ihlr-18810	400	2	iom	iom	PROPN
ihlr-18810	400	3	report	report	NOUN
ihlr-18810	400	4	,	,	PUNCT
ihlr-18810	400	5	supra	supra	PROPN
ihlr-18810	400	6	note	note	NOUN
ihlr-18810	400	7	6	6	NUM
ihlr-18810	400	8	,	,	PUNCT
ihlr-18810	400	9	at	at	ADP
ihlr-18810	400	10	134	134	NUM
ihlr-18810	400	11	-	-	SYM
ihlr-18810	400	12	35	35	NUM
ihlr-18810	400	13	.	.	PUNCT
ihlr-18810	401	1	157	157	NUM
ihlr-18810	401	2	21	21	NUM
ihlr-18810	401	3	c.f.r	c.f.r	NOUN
ihlr-18810	401	4	.	.	PUNCT
ihlr-18810	402	1	§	§	PROPN
ihlr-18810	402	2	806.10	806.10	NUM
ihlr-18810	402	3	(	(	PUNCT
ihlr-18810	402	4	2012	2012	NUM
ihlr-18810	402	5	)	)	PUNCT
ihlr-18810	402	6	.	.	PUNCT
ihlr-18810	403	1	158	158	NUM
ihlr-18810	403	2	iom	iom	PROPN
ihlr-18810	403	3	report	report	NOUN
ihlr-18810	403	4	,	,	PUNCT
ihlr-18810	403	5	supra	supra	PROPN
ihlr-18810	403	6	note	note	NOUN
ihlr-18810	403	7	6	6	NUM
ihlr-18810	403	8	,	,	PUNCT
ihlr-18810	403	9	at	at	ADP
ihlr-18810	403	10	135	135	NUM
ihlr-18810	403	11	(	(	PUNCT
ihlr-18810	403	12	noting	note	VERB
ihlr-18810	403	13	that	that	SCONJ
ihlr-18810	403	14	degree	degree	NOUN
ihlr-18810	403	15	of	of	ADP
ihlr-18810	403	16	hazard	hazard	NOUN
ihlr-18810	403	17	determinations	determination	NOUN
ihlr-18810	403	18	are	be	AUX
ihlr-18810	403	19	"	"	PUNCT
ihlr-18810	403	20	based	base	VERB
ihlr-18810	403	21	on	on	ADP
ihlr-18810	403	22	injuries	injury	NOUN
ihlr-18810	403	23	or	or	CCONJ
ihlr-18810	403	24	deaths	death	NOUN
ihlr-18810	403	25	that	that	PRON
ihlr-18810	403	26	have	have	AUX
ihlr-18810	403	27	occurred	occur	VERB
ihlr-18810	403	28	,	,	PUNCT
ihlr-18810	403	29	the	the	DET
ihlr-18810	403	30	likelihood	likelihood	NOUN
ihlr-18810	403	31	of	of	ADP
ihlr-18810	403	32	occurrence	occurrence	NOUN
ihlr-18810	403	33	,	,	PUNCT
ihlr-18810	403	34	the	the	DET
ihlr-18810	403	35	population	population	NOUN
ihlr-18810	403	36	exposed	expose	VERB
ihlr-18810	403	37	,	,	PUNCT
ihlr-18810	403	38	and	and	CCONJ
ihlr-18810	403	39	the	the	DET
ihlr-18810	403	40	immediate	immediate	ADJ
ihlr-18810	403	41	and	and	CCONJ
ihlr-18810	403	42	long	long	ADJ
ihlr-18810	403	43	-	-	PUNCT
ihlr-18810	403	44	term	term	NOUN
ihlr-18810	403	45	consequences	consequence	NOUN
ihlr-18810	403	46	"	"	PUNCT
ihlr-18810	403	47	)	)	PUNCT
ihlr-18810	403	48	.	.	PUNCT
ihlr-18810	404	1	159	159	NUM
ihlr-18810	404	2	21	21	NUM
ihlr-18810	404	3	cfr	cfr	NOUN
ihlr-18810	404	4	§	§	PROPN
ihlr-18810	404	5	7.3(m)(1	7.3(m)(1	PROPN
ihlr-18810	404	6	)	)	PUNCT
ihlr-18810	404	7	.	.	PUNCT
ihlr-18810	405	1	160	160	NUM
ihlr-18810	405	2	21	21	NUM
ihlr-18810	405	3	cfr	cfr	NOUN
ihlr-18810	405	4	§	§	PROPN
ihlr-18810	405	5	7.3(m)(2	7.3(m)(2	PROPN
ihlr-18810	405	6	)	)	PUNCT
ihlr-18810	405	7	.	.	PUNCT
ihlr-18810	406	1	161	161	NUM
ihlr-18810	406	2	21	21	NUM
ihlr-18810	406	3	cfr	cfr	NOUN
ihlr-18810	406	4	§	§	PROPN
ihlr-18810	406	5	7.3(m)(3	7.3(m)(3	PROPN
ihlr-18810	406	6	)	)	PUNCT
ihlr-18810	406	7	.	.	PUNCT
ihlr-18810	407	1	2013	2013	NUM
ihlr-18810	407	2	143	143	NUM
ihlr-18810	407	3	indiana	indiana	PROPN
ihlr-18810	407	4	health	health	PROPN
ihlr-18810	407	5	law	law	PROPN
ihlr-18810	407	6	review	review	NOUN
ihlr-18810	407	7	product	product	NOUN
ihlr-18810	407	8	's	's	PART
ihlr-18810	407	9	life	life	NOUN
ihlr-18810	407	10	cycle	cycle	NOUN
ihlr-18810	407	11	at	at	ADP
ihlr-18810	407	12	which	which	PRON
ihlr-18810	407	13	safety	safety	NOUN
ihlr-18810	407	14	problems	problem	NOUN
ihlr-18810	407	15	may	may	AUX
ihlr-18810	407	16	begin	begin	VERB
ihlr-18810	407	17	to	to	PART
ihlr-18810	407	18	arise	arise	VERB
ihlr-18810	407	19	,	,	PUNCT
ihlr-18810	407	20	improved	improve	VERB
ihlr-18810	407	21	postmarket	postmarket	ADJ
ihlr-18810	407	22	surveillance	surveillance	NOUN
ihlr-18810	407	23	will	will	AUX
ihlr-18810	407	24	still	still	ADV
ihlr-18810	407	25	be	be	AUX
ihlr-18810	407	26	required	require	VERB
ihlr-18810	407	27	to	to	PART
ihlr-18810	407	28	provide	provide	VERB
ihlr-18810	407	29	the	the	DET
ihlr-18810	407	30	full	full	ADJ
ihlr-18810	407	31	story	story	NOUN
ihlr-18810	407	32	of	of	ADP
ihlr-18810	407	33	the	the	DET
ihlr-18810	407	34	safety	safety	NOUN
ihlr-18810	407	35	of	of	ADP
ihlr-18810	407	36	devices	device	NOUN
ihlr-18810	407	37	in	in	ADP
ihlr-18810	407	38	clinical	clinical	ADJ
ihlr-18810	407	39	use.162	use.162	NOUN
ihlr-18810	407	40	for	for	ADP
ihlr-18810	407	41	example	example	NOUN
ihlr-18810	407	42	,	,	PUNCT
ihlr-18810	407	43	it	it	PRON
ihlr-18810	407	44	is	be	AUX
ihlr-18810	407	45	easy	easy	ADJ
ihlr-18810	407	46	to	to	PART
ihlr-18810	407	47	assume	assume	VERB
ihlr-18810	407	48	that	that	SCONJ
ihlr-18810	407	49	all	all	DET
ihlr-18810	407	50	devices	device	NOUN
ihlr-18810	407	51	which	which	PRON
ihlr-18810	407	52	have	have	AUX
ihlr-18810	407	53	not	not	PART
ihlr-18810	407	54	been	be	AUX
ihlr-18810	407	55	recalled	recall	VERB
ihlr-18810	407	56	by	by	ADP
ihlr-18810	407	57	the	the	DET
ihlr-18810	407	58	fda	fda	PROPN
ihlr-18810	407	59	are	be	AUX
ihlr-18810	407	60	safe	safe	ADJ
ihlr-18810	407	61	and	and	CCONJ
ihlr-18810	407	62	pose	pose	VERB
ihlr-18810	407	63	no	no	DET
ihlr-18810	407	64	potential	potential	ADJ
ihlr-18810	407	65	safety	safety	NOUN
ihlr-18810	407	66	problems	problem	NOUN
ihlr-18810	407	67	;	;	PUNCT
ihlr-18810	407	68	however	however	ADV
ihlr-18810	407	69	,	,	PUNCT
ihlr-18810	407	70	the	the	DET
ihlr-18810	407	71	possibility	possibility	NOUN
ihlr-18810	407	72	remains	remain	VERB
ihlr-18810	407	73	that	that	SCONJ
ihlr-18810	407	74	some	some	PRON
ihlr-18810	407	75	of	of	ADP
ihlr-18810	407	76	these	these	DET
ihlr-18810	407	77	devices	device	NOUN
ihlr-18810	407	78	could	could	AUX
ihlr-18810	407	79	have	have	VERB
ihlr-18810	407	80	safety	safety	NOUN
ihlr-18810	407	81	problems	problem	NOUN
ihlr-18810	407	82	that	that	PRON
ihlr-18810	407	83	have	have	AUX
ihlr-18810	407	84	so	so	ADV
ihlr-18810	407	85	far	far	ADV
ihlr-18810	407	86	remained	remain	VERB
ihlr-18810	407	87	undetected	undetected	ADJ
ihlr-18810	407	88	.	.	PUNCT
ihlr-18810	408	1	a	a	DET
ihlr-18810	408	2	study	study	NOUN
ihlr-18810	408	3	of	of	ADP
ihlr-18810	408	4	510(k	510(k	PROPN
ihlr-18810	408	5	)	)	PUNCT
ihlr-18810	408	6	devices	device	NOUN
ihlr-18810	408	7	cleared	clear	VERB
ihlr-18810	408	8	between	between	ADP
ihlr-18810	408	9	1996	1996	NUM
ihlr-18810	408	10	and	and	CCONJ
ihlr-18810	408	11	2009	2009	NUM
ihlr-18810	408	12	revealed	reveal	VERB
ihlr-18810	408	13	that	that	SCONJ
ihlr-18810	408	14	3,132	3,132	NUM
ihlr-18810	408	15	devices	device	NOUN
ihlr-18810	408	16	,	,	PUNCT
ihlr-18810	408	17	or	or	CCONJ
ihlr-18810	408	18	6.47	6.47	NUM
ihlr-18810	408	19	%	%	NOUN
ihlr-18810	408	20	,	,	PUNCT
ihlr-18810	408	21	were	be	AUX
ihlr-18810	408	22	recalled	recall	VERB
ihlr-18810	408	23	between	between	ADP
ihlr-18810	408	24	2003	2003	NUM
ihlr-18810	408	25	and	and	CCONJ
ihlr-18810	408	26	2009	2009	NUM
ihlr-18810	408	27	,	,	PUNCT
ihlr-18810	408	28	and	and	CCONJ
ihlr-18810	408	29	of	of	ADP
ihlr-18810	408	30	those	those	DET
ihlr-18810	408	31	devices	device	NOUN
ihlr-18810	408	32	,	,	PUNCT
ihlr-18810	408	33	26.1	26.1	NUM
ihlr-18810	408	34	%	%	NOUN
ihlr-18810	408	35	were	be	AUX
ihlr-18810	408	36	recalled	recall	VERB
ihlr-18810	408	37	multiple	multiple	ADJ
ihlr-18810	408	38	times.163	times.163	PRON
ihlr-18810	408	39	most	most	ADJ
ihlr-18810	408	40	of	of	ADP
ihlr-18810	408	41	these	these	PRON
ihlr-18810	408	42	recalls	recall	VERB
ihlr-18810	408	43	were	be	AUX
ihlr-18810	408	44	due	due	ADJ
ihlr-18810	408	45	to	to	ADP
ihlr-18810	408	46	errors	error	NOUN
ihlr-18810	408	47	in	in	ADP
ihlr-18810	408	48	device	device	NOUN
ihlr-18810	408	49	manufacture	manufacture	NOUN
ihlr-18810	408	50	or	or	CCONJ
ihlr-18810	408	51	design	design	NOUN
ihlr-18810	408	52	,	,	PUNCT
ihlr-18810	408	53	28.8	28.8	NUM
ihlr-18810	408	54	%	%	NOUN
ihlr-18810	408	55	and	and	CCONJ
ihlr-18810	408	56	28.4	28.4	NUM
ihlr-18810	408	57	%	%	NOUN
ihlr-18810	408	58	respectively.164	respectively.164	NOUN
ihlr-18810	408	59	among	among	ADP
ihlr-18810	408	60	the	the	DET
ihlr-18810	408	61	devices	device	NOUN
ihlr-18810	408	62	cleared	clear	VERB
ihlr-18810	408	63	after	after	ADP
ihlr-18810	408	64	2003	2003	NUM
ihlr-18810	408	65	,	,	PUNCT
ihlr-18810	408	66	the	the	DET
ihlr-18810	408	67	vast	vast	ADJ
ihlr-18810	408	68	majority	majority	NOUN
ihlr-18810	408	69	,	,	PUNCT
ihlr-18810	408	70	91.5	91.5	NUM
ihlr-18810	408	71	%	%	NOUN
ihlr-18810	408	72	remained	remain	VERB
ihlr-18810	408	73	free	free	ADJ
ihlr-18810	408	74	of	of	ADP
ihlr-18810	408	75	recalls	recall	VERB
ihlr-18810	408	76	six	six	NUM
ihlr-18810	408	77	years	year	NOUN
ihlr-18810	408	78	after	after	ADP
ihlr-18810	408	79	clearance	clearance	NOUN
ihlr-18810	408	80	.	.	PUNCT
ihlr-18810	408	81	'	'	PUNCT
ihlr-18810	409	1	65	65	NUM
ihlr-18810	409	2	in	in	ADP
ihlr-18810	409	3	2011	2011	NUM
ihlr-18810	409	4	,	,	PUNCT
ihlr-18810	409	5	the	the	DET
ihlr-18810	409	6	fda	fda	PROPN
ihlr-18810	409	7	's	's	PART
ihlr-18810	409	8	center	center	NOUN
ihlr-18810	409	9	for	for	ADP
ihlr-18810	409	10	devices	device	NOUN
ihlr-18810	409	11	and	and	CCONJ
ihlr-18810	409	12	radiological	radiological	ADJ
ihlr-18810	409	13	health	health	NOUN
ihlr-18810	409	14	recalled	recall	VERB
ihlr-18810	409	15	3,211	3,211	NUM
ihlr-18810	409	16	devices.166	devices.166	NOUN
ihlr-18810	409	17	the	the	DET
ihlr-18810	409	18	fda	fda	PROPN
ihlr-18810	409	19	has	have	VERB
ihlr-18810	409	20	many	many	ADJ
ihlr-18810	409	21	enforcement	enforcement	NOUN
ihlr-18810	409	22	options	option	NOUN
ihlr-18810	409	23	available	available	ADJ
ihlr-18810	409	24	to	to	ADP
ihlr-18810	409	25	it	it	PRON
ihlr-18810	409	26	,	,	PUNCT
ihlr-18810	409	27	and	and	CCONJ
ihlr-18810	409	28	consequently	consequently	ADV
ihlr-18810	409	29	many	many	ADJ
ihlr-18810	409	30	mechanisms	mechanism	NOUN
ihlr-18810	409	31	by	by	ADP
ihlr-18810	409	32	which	which	PRON
ihlr-18810	409	33	to	to	PART
ihlr-18810	409	34	ensure	ensure	VERB
ihlr-18810	409	35	compliance	compliance	NOUN
ihlr-18810	409	36	with	with	ADP
ihlr-18810	409	37	its	its	PRON
ihlr-18810	409	38	regulations	regulation	NOUN
ihlr-18810	409	39	,	,	PUNCT
ihlr-18810	409	40	but	but	CCONJ
ihlr-18810	409	41	it	it	PRON
ihlr-18810	409	42	is	be	AUX
ihlr-18810	409	43	the	the	DET
ihlr-18810	409	44	actual	actual	ADJ
ihlr-18810	409	45	utilization	utilization	NOUN
ihlr-18810	409	46	of	of	ADP
ihlr-18810	409	47	these	these	DET
ihlr-18810	409	48	powers	power	NOUN
ihlr-18810	409	49	that	that	PRON
ihlr-18810	409	50	improves	improve	VERB
ihlr-18810	409	51	the	the	DET
ihlr-18810	409	52	safety	safety	NOUN
ihlr-18810	409	53	of	of	ADP
ihlr-18810	409	54	devices	device	NOUN
ihlr-18810	409	55	on	on	ADP
ihlr-18810	409	56	the	the	DET
ihlr-18810	409	57	market	market	NOUN
ihlr-18810	409	58	.	.	PUNCT
ihlr-18810	410	1	there	there	PRON
ihlr-18810	410	2	has	have	AUX
ihlr-18810	410	3	been	be	AUX
ihlr-18810	410	4	a	a	DET
ihlr-18810	410	5	decline	decline	NOUN
ihlr-18810	410	6	in	in	ADP
ihlr-18810	410	7	fda	fda	PROPN
ihlr-18810	410	8	enforcement	enforcement	NOUN
ihlr-18810	410	9	actions	action	NOUN
ihlr-18810	410	10	,	,	PUNCT
ihlr-18810	410	11	however	however	ADV
ihlr-18810	410	12	.	.	PUNCT
ihlr-18810	411	1	the	the	DET
ihlr-18810	411	2	issuance	issuance	NOUN
ihlr-18810	411	3	of	of	ADP
ihlr-18810	411	4	warning	warning	NOUN
ihlr-18810	411	5	letters	letter	NOUN
ihlr-18810	411	6	declined	decline	VERB
ihlr-18810	411	7	by	by	ADP
ihlr-18810	411	8	50	50	NUM
ihlr-18810	411	9	%	%	NOUN
ihlr-18810	411	10	between	between	ADP
ihlr-18810	411	11	2000	2000	NUM
ihlr-18810	411	12	and	and	CCONJ
ihlr-18810	411	13	2005	2005	NUM
ihlr-18810	411	14	,	,	PUNCT
ihlr-18810	411	15	reaching	reach	VERB
ihlr-18810	411	16	a	a	DET
ihlr-18810	411	17	fifteen	fifteen	NUM
ihlr-18810	411	18	year	year	NOUN
ihlr-18810	411	19	low.167	low.167	NOUN
ihlr-18810	411	20	the	the	DET
ihlr-18810	411	21	fda	fda	PROPN
ihlr-18810	411	22	center	center	NOUN
ihlr-18810	411	23	with	with	ADP
ihlr-18810	411	24	the	the	DET
ihlr-18810	411	25	largest	large	ADJ
ihlr-18810	411	26	decrease	decrease	NOUN
ihlr-18810	411	27	was	be	AUX
ihlr-18810	411	28	the	the	DET
ihlr-18810	411	29	center	center	NOUN
ihlr-18810	411	30	for	for	ADP
ihlr-18810	411	31	devices	device	NOUN
ihlr-18810	411	32	and	and	CCONJ
ihlr-18810	411	33	radiological	radiological	ADJ
ihlr-18810	411	34	health	health	NOUN
ihlr-18810	411	35	which	which	PRON
ihlr-18810	411	36	,	,	PUNCT
ihlr-18810	411	37	even	even	ADV
ihlr-18810	411	38	in	in	ADP
ihlr-18810	411	39	light	light	NOUN
ihlr-18810	411	40	of	of	ADP
ihlr-18810	411	41	growing	grow	VERB
ihlr-18810	411	42	reports	report	NOUN
ihlr-18810	411	43	of	of	ADP
ihlr-18810	411	44	device	device	NOUN
ihlr-18810	411	45	162	162	NUM
ihlr-18810	411	46	iom	iom	PROPN
ihlr-18810	411	47	report	report	NOUN
ihlr-18810	411	48	,	,	PUNCT
ihlr-18810	411	49	supra	supra	PROPN
ihlr-18810	411	50	note	note	NOUN
ihlr-18810	411	51	6	6	NUM
ihlr-18810	411	52	,	,	PUNCT
ihlr-18810	411	53	at	at	ADP
ihlr-18810	411	54	135	135	NUM
ihlr-18810	411	55	163	163	NUM
ihlr-18810	411	56	william	william	PROPN
ihlr-18810	411	57	h.	h.	PROPN
ihlr-18810	411	58	maisel	maisel	PROPN
ihlr-18810	411	59	,	,	PUNCT
ihlr-18810	411	60	510(k	510(k	NUM
ihlr-18810	411	61	)	)	PUNCT
ihlr-18810	411	62	premarket	premarket	NOUN
ihlr-18810	411	63	notification	notification	NOUN
ihlr-18810	411	64	analysis	analysis	NOUN
ihlr-18810	411	65	of	of	ADP
ihlr-18810	411	66	fda	fda	PROPN
ihlr-18810	411	67	recall	recall	PROPN
ihlr-18810	411	68	data	data	PROPN
ihlr-18810	411	69	,	,	PUNCT
ihlr-18810	411	70	in	in	ADP
ihlr-18810	411	71	public	public	ADJ
ihlr-18810	411	72	health	health	NOUN
ihlr-18810	411	73	effectiveness	effectiveness	NOUN
ihlr-18810	411	74	of	of	ADP
ihlr-18810	411	75	the	the	DET
ihlr-18810	411	76	fda	fda	PROPN
ihlr-18810	411	77	510(k	510(k	PROPN
ihlr-18810	411	78	)	)	PUNCT
ihlr-18810	411	79	clearance	clearance	NOUN
ihlr-18810	411	80	process	process	NOUN
ihlr-18810	411	81	:	:	PUNCT
ihlr-18810	411	82	measuring	measure	VERB
ihlr-18810	411	83	postmarket	postmarket	ADJ
ihlr-18810	411	84	performance	performance	NOUN
ihlr-18810	411	85	and	and	CCONJ
ihlr-18810	411	86	other	other	ADJ
ihlr-18810	411	87	select	select	ADJ
ihlr-18810	411	88	topics	topic	NOUN
ihlr-18810	411	89	:	:	PUNCT
ihlr-18810	411	90	workshop	workshop	NOUN
ihlr-18810	411	91	report	report	NOUN
ihlr-18810	411	92	73	73	NUM
ihlr-18810	411	93	(	(	PUNCT
ihlr-18810	411	94	theresa	theresa	PROPN
ihlr-18810	411	95	wizemann	wizemann	PROPN
ihlr-18810	411	96	ed	ed	PROPN
ihlr-18810	411	97	.	.	PROPN
ihlr-18810	411	98	,	,	PUNCT
ihlr-18810	411	99	2011	2011	NUM
ihlr-18810	411	100	)	)	PUNCT
ihlr-18810	411	101	.	.	PUNCT
ihlr-18810	412	1	164	164	NUM
ihlr-18810	413	1	i	i	PRON
ihlr-18810	413	2	d.	d.	NOUN
ihlr-18810	413	3	at	at	ADP
ihlr-18810	413	4	73	73	NUM
ihlr-18810	413	5	-	-	SYM
ihlr-18810	413	6	74	74	NUM
ihlr-18810	413	7	.	.	PUNCT
ihlr-18810	414	1	165	165	NUM
ihlr-18810	415	1	i	i	PRON
ihlr-18810	415	2	d.	d.	PROPN
ihlr-18810	415	3	at	at	ADP
ihlr-18810	415	4	73	73	NUM
ihlr-18810	415	5	.	.	PUNCT
ihlr-18810	416	1	166	166	NUM
ihlr-18810	416	2	total	total	ADJ
ihlr-18810	416	3	recalled	recall	VERB
ihlr-18810	416	4	products	product	NOUN
ihlr-18810	416	5	by	by	ADP
ihlr-18810	416	6	fda	fda	PROPN
ihlr-18810	416	7	center	center	PROPN
ihlr-18810	416	8	fiscal	fiscal	ADJ
ihlr-18810	416	9	year	year	NOUN
ihlr-18810	416	10	2011	2011	NUM
ihlr-18810	416	11	,	,	PUNCT
ihlr-18810	416	12	fda.gov	fda.gov	NUM
ihlr-18810	416	13	,	,	PUNCT
ihlr-18810	416	14	http://www.fda.gov/downloads/iceci/enforcementactions/	http://www.fda.gov/downloads/iceci/enforcementactions/	PROPN
ihlr-18810	416	15	ucm285781.pdf	ucm285781.pdf	NOUN
ihlr-18810	416	16	.	.	PUNCT
ihlr-18810	417	1	167	167	NUM
ihlr-18810	417	2	u.s	u.s	PROPN
ihlr-18810	417	3	.	.	PROPN
ihlr-18810	417	4	house	house	PROPN
ihlr-18810	417	5	of	of	ADP
ihlr-18810	417	6	reps	reps	PROPN
ihlr-18810	417	7	.	.	PROPN
ihlr-18810	417	8	comm	comm	NOUN
ihlr-18810	417	9	.	.	PUNCT
ihlr-18810	418	1	on	on	ADP
ihlr-18810	418	2	gov't	gov't	NOUN
ihlr-18810	418	3	reform	reform	NOUN
ihlr-18810	418	4	minority	minority	NOUN
ihlr-18810	418	5	staff	staff	NOUN
ihlr-18810	418	6	special	special	ADJ
ihlr-18810	418	7	investigation	investigation	NOUN
ihlr-18810	418	8	div	div	PROPN
ihlr-18810	418	9	.	.	PROPN
ihlr-18810	418	10	,	,	PUNCT
ihlr-18810	418	11	prescription	prescription	NOUN
ihlr-18810	418	12	for	for	ADP
ihlr-18810	418	13	harm	harm	NOUN
ihlr-18810	418	14	:	:	PUNCT
ihlr-18810	418	15	the	the	DET
ihlr-18810	418	16	decline	decline	NOUN
ihlr-18810	418	17	in	in	ADP
ihlr-18810	418	18	fda	fda	PROPN
ihlr-18810	418	19	enforcement	enforcement	NOUN
ihlr-18810	418	20	activity	activity	NOUN
ihlr-18810	418	21	i	i	PRON
ihlr-18810	418	22	(	(	PUNCT
ihlr-18810	418	23	2006	2006	NUM
ihlr-18810	418	24	)	)	PUNCT
ihlr-18810	419	1	[	[	X
ihlr-18810	419	2	hereinafter	hereinafter	NOUN
ihlr-18810	419	3	decline	decline	NOUN
ihlr-18810	419	4	in	in	ADP
ihlr-18810	419	5	enforcement	enforcement	NOUN
ihlr-18810	419	6	]	]	PUNCT
ihlr-18810	419	7	,	,	PUNCT
ihlr-18810	419	8	available	available	ADJ
ihlr-18810	419	9	at	at	ADP
ihlr-18810	419	10	http://oversight-archive.waxman	http://oversight-archive.waxman	PROPN
ihlr-18810	419	11	.	.	PUNCT
ihlr-18810	420	1	house.gov/documents/	house.gov/documents/	NOUN
ihlr-18810	420	2	20060627101434-98349.pdf	20060627101434-98349.pdf	NOUN
ihlr-18810	420	3	.	.	PUNCT
ihlr-18810	421	1	vol	vol	NOUN
ihlr-18810	421	2	.	.	PUNCT
ihlr-18810	422	1	10	10	NUM
ihlr-18810	422	2	:	:	SYM
ihlr-18810	422	3	1144	1144	NUM
ihlr-18810	422	4	510(k	510(k	NUM
ihlr-18810	422	5	)	)	PUNCT
ihlr-18810	422	6	clearance	clearance	NOUN
ihlr-18810	422	7	malfunctions	malfunction	NOUN
ihlr-18810	422	8	during	during	ADP
ihlr-18810	422	9	this	this	DET
ihlr-18810	422	10	period	period	NOUN
ihlr-18810	422	11	,	,	PUNCT
ihlr-18810	422	12	issued	issue	VERB
ihlr-18810	422	13	65	65	NUM
ihlr-18810	422	14	%	%	NOUN
ihlr-18810	422	15	fewer	few	ADJ
ihlr-18810	422	16	warning	warning	NOUN
ihlr-18810	422	17	letters	letter	NOUN
ihlr-18810	422	18	in	in	ADP
ihlr-18810	422	19	2005	2005	NUM
ihlr-18810	422	20	than	than	ADP
ihlr-18810	422	21	2000.168	2000.168	NUM
ihlr-18810	422	22	this	this	PRON
ihlr-18810	422	23	is	be	AUX
ihlr-18810	422	24	an	an	DET
ihlr-18810	422	25	alarming	alarming	ADJ
ihlr-18810	422	26	statistic	statistic	NOUN
ihlr-18810	422	27	,	,	PUNCT
ihlr-18810	422	28	particularly	particularly	ADV
ihlr-18810	422	29	since	since	SCONJ
ihlr-18810	422	30	reports	report	NOUN
ihlr-18810	422	31	have	have	AUX
ihlr-18810	422	32	shown	show	VERB
ihlr-18810	422	33	that	that	SCONJ
ihlr-18810	422	34	the	the	DET
ihlr-18810	422	35	number	number	NOUN
ihlr-18810	422	36	of	of	ADP
ihlr-18810	422	37	violations	violation	NOUN
ihlr-18810	422	38	the	the	DET
ihlr-18810	422	39	fda	fda	PROPN
ihlr-18810	422	40	has	have	AUX
ihlr-18810	422	41	observed	observe	VERB
ihlr-18810	422	42	during	during	ADP
ihlr-18810	422	43	field	field	NOUN
ihlr-18810	422	44	inspections	inspection	NOUN
ihlr-18810	422	45	has	have	AUX
ihlr-18810	422	46	remained	remain	VERB
ihlr-18810	422	47	fairly	fairly	ADV
ihlr-18810	422	48	constant	constant	ADJ
ihlr-18810	422	49	over	over	ADP
ihlr-18810	422	50	the	the	DET
ihlr-18810	422	51	years	year	NOUN
ihlr-18810	422	52	.	.	PUNCT
ihlr-18810	423	1	169	169	NUM
ihlr-18810	423	2	b.	b.	PROPN
ihlr-18810	423	3	judicial	judicial	NOUN
ihlr-18810	423	4	if	if	SCONJ
ihlr-18810	423	5	the	the	DET
ihlr-18810	423	6	administrative	administrative	ADJ
ihlr-18810	423	7	powers	power	NOUN
ihlr-18810	423	8	discussed	discuss	VERB
ihlr-18810	423	9	above	above	ADV
ihlr-18810	423	10	are	be	AUX
ihlr-18810	423	11	not	not	PART
ihlr-18810	423	12	appropriate	appropriate	ADJ
ihlr-18810	423	13	for	for	ADP
ihlr-18810	423	14	a	a	DET
ihlr-18810	423	15	particular	particular	ADJ
ihlr-18810	423	16	device	device	NOUN
ihlr-18810	423	17	,	,	PUNCT
ihlr-18810	423	18	the	the	DET
ihlr-18810	423	19	fda	fda	PROPN
ihlr-18810	423	20	also	also	ADV
ihlr-18810	423	21	has	have	VERB
ihlr-18810	423	22	the	the	DET
ihlr-18810	423	23	authority	authority	NOUN
ihlr-18810	423	24	to	to	PART
ihlr-18810	423	25	exercise	exercise	VERB
ihlr-18810	423	26	a	a	DET
ihlr-18810	423	27	number	number	NOUN
ihlr-18810	423	28	of	of	ADP
ihlr-18810	423	29	judicial	judicial	ADJ
ihlr-18810	423	30	enforcement	enforcement	NOUN
ihlr-18810	423	31	powers	power	NOUN
ihlr-18810	423	32	.	.	PUNCT
ihlr-18810	424	1	section	section	PROPN
ihlr-18810	424	2	304(g	304(g	PROPN
ihlr-18810	424	3	)	)	PUNCT
ihlr-18810	424	4	of	of	ADP
ihlr-18810	424	5	the	the	DET
ihlr-18810	424	6	fdca	fdca	NOUN
ihlr-18810	424	7	provides	provide	VERB
ihlr-18810	424	8	that	that	SCONJ
ihlr-18810	424	9	the	the	DET
ihlr-18810	424	10	fda	fda	PROPN
ihlr-18810	424	11	can	can	AUX
ihlr-18810	424	12	detain	detain	VERB
ihlr-18810	424	13	devices	device	NOUN
ihlr-18810	424	14	for	for	ADP
ihlr-18810	424	15	up	up	ADP
ihlr-18810	424	16	to	to	PART
ihlr-18810	424	17	thirty	thirty	NUM
ihlr-18810	424	18	days	day	NOUN
ihlr-18810	424	19	if	if	SCONJ
ihlr-18810	424	20	it	it	PRON
ihlr-18810	424	21	has	have	VERB
ihlr-18810	424	22	reason	reason	NOUN
ihlr-18810	424	23	to	to	PART
ihlr-18810	424	24	believe	believe	VERB
ihlr-18810	424	25	the	the	DET
ihlr-18810	424	26	devices	device	NOUN
ihlr-18810	424	27	are	be	AUX
ihlr-18810	424	28	adulterated	adulterate	VERB
ihlr-18810	424	29	or	or	CCONJ
ihlr-18810	424	30	misbranded	misbrande	VERB
ihlr-18810	424	31	.	.	PROPN
ihlr-18810	424	32	170	170	NUM
ihlr-18810	424	33	the	the	DET
ihlr-18810	424	34	most	most	ADV
ihlr-18810	424	35	common	common	ADJ
ihlr-18810	424	36	method	method	NOUN
ihlr-18810	424	37	for	for	ADP
ihlr-18810	424	38	detaining	detain	VERB
ihlr-18810	424	39	products	product	NOUN
ihlr-18810	424	40	is	be	AUX
ihlr-18810	424	41	seizure	seizure	VERB
ihlr-18810	424	42	,	,	PUNCT
ihlr-18810	424	43	which	which	PRON
ihlr-18810	424	44	can	can	AUX
ihlr-18810	424	45	occur	occur	VERB
ihlr-18810	424	46	anytime	anytime	ADV
ihlr-18810	424	47	a	a	DET
ihlr-18810	424	48	suspected	suspect	VERB
ihlr-18810	424	49	adulterated	adulterate	VERB
ihlr-18810	424	50	or	or	CCONJ
ihlr-18810	424	51	misbranded	misbrande	VERB
ihlr-18810	424	52	device	device	NOUN
ihlr-18810	424	53	is	be	AUX
ihlr-18810	424	54	in	in	ADP
ihlr-18810	424	55	interstate	interstate	PROPN
ihlr-18810	424	56	commerce	commerce	NOUN
ihlr-18810	424	57	,	,	PUNCT
ihlr-18810	424	58	held	hold	VERB
ihlr-18810	424	59	for	for	ADP
ihlr-18810	424	60	sale	sale	NOUN
ihlr-18810	424	61	,	,	PUNCT
ihlr-18810	424	62	or	or	CCONJ
ihlr-18810	424	63	any	any	DET
ihlr-18810	424	64	time	time	NOUN
ihlr-18810	424	65	after.171	after.171	VERB
ihlr-18810	424	66	the	the	DET
ihlr-18810	424	67	devices	device	NOUN
ihlr-18810	424	68	will	will	AUX
ihlr-18810	424	69	be	be	AUX
ihlr-18810	424	70	held	hold	VERB
ihlr-18810	424	71	until	until	SCONJ
ihlr-18810	424	72	a	a	DET
ihlr-18810	424	73	condemnation	condemnation	NOUN
ihlr-18810	424	74	decree	decree	NOUN
ihlr-18810	424	75	is	be	AUX
ihlr-18810	424	76	rendered	render	VERB
ihlr-18810	424	77	by	by	ADP
ihlr-18810	424	78	a	a	DET
ihlr-18810	424	79	court	court	NOUN
ihlr-18810	424	80	,	,	PUNCT
ihlr-18810	424	81	at	at	ADP
ihlr-18810	424	82	which	which	DET
ihlr-18810	424	83	point	point	NOUN
ihlr-18810	424	84	they	they	PRON
ihlr-18810	424	85	may	may	AUX
ihlr-18810	424	86	be	be	AUX
ihlr-18810	424	87	destroyed	destroy	VERB
ihlr-18810	424	88	as	as	ADP
ihlr-18810	424	89	the	the	DET
ihlr-18810	424	90	court	court	NOUN
ihlr-18810	424	91	directs.172	directs.172	PROPN
ihlr-18810	424	92	although	although	SCONJ
ihlr-18810	424	93	this	this	PRON
ihlr-18810	424	94	may	may	AUX
ihlr-18810	424	95	be	be	AUX
ihlr-18810	424	96	an	an	DET
ihlr-18810	424	97	effective	effective	ADJ
ihlr-18810	424	98	way	way	NOUN
ihlr-18810	424	99	to	to	PART
ihlr-18810	424	100	prevent	prevent	VERB
ihlr-18810	424	101	consumers	consumer	NOUN
ihlr-18810	424	102	from	from	ADP
ihlr-18810	424	103	suffering	suffer	VERB
ihlr-18810	424	104	harm	harm	NOUN
ihlr-18810	424	105	from	from	ADP
ihlr-18810	424	106	adulterated	adulterate	VERB
ihlr-18810	424	107	or	or	CCONJ
ihlr-18810	424	108	misbranded	misbranded	ADJ
ihlr-18810	424	109	devices	device	NOUN
ihlr-18810	424	110	,	,	PUNCT
ihlr-18810	424	111	this	this	DET
ihlr-18810	424	112	enforcement	enforcement	NOUN
ihlr-18810	424	113	action	action	NOUN
ihlr-18810	424	114	will	will	AUX
ihlr-18810	424	115	not	not	PART
ihlr-18810	424	116	offer	offer	VERB
ihlr-18810	424	117	much	much	ADJ
ihlr-18810	424	118	help	help	NOUN
ihlr-18810	424	119	in	in	ADP
ihlr-18810	424	120	protecting	protect	VERB
ihlr-18810	424	121	the	the	DET
ihlr-18810	424	122	public	public	NOUN
ihlr-18810	424	123	from	from	ADP
ihlr-18810	424	124	unsafe	unsafe	ADJ
ihlr-18810	424	125	devices	device	NOUN
ihlr-18810	424	126	cleared	clear	VERB
ihlr-18810	424	127	through	through	ADP
ihlr-18810	424	128	the	the	DET
ihlr-18810	424	129	510(k	510(k	PROPN
ihlr-18810	424	130	)	)	PUNCT
ihlr-18810	424	131	process	process	NOUN
ihlr-18810	424	132	,	,	PUNCT
ihlr-18810	424	133	because	because	SCONJ
ihlr-18810	424	134	these	these	DET
ihlr-18810	424	135	actions	action	NOUN
ihlr-18810	424	136	do	do	AUX
ihlr-18810	424	137	not	not	PART
ihlr-18810	424	138	reach	reach	VERB
ihlr-18810	424	139	products	product	NOUN
ihlr-18810	424	140	that	that	PRON
ihlr-18810	424	141	may	may	AUX
ihlr-18810	424	142	be	be	AUX
ihlr-18810	424	143	injurious	injurious	ADJ
ihlr-18810	424	144	due	due	ADP
ihlr-18810	424	145	to	to	ADP
ihlr-18810	424	146	their	their	PRON
ihlr-18810	424	147	design.173	design.173	NOUN
ihlr-18810	424	148	in	in	ADP
ihlr-18810	424	149	fiscal	fiscal	ADJ
ihlr-18810	424	150	year	year	NOUN
ihlr-18810	424	151	2011	2011	NUM
ihlr-18810	424	152	,	,	PUNCT
ihlr-18810	424	153	the	the	DET
ihlr-18810	424	154	fda	fda	PROPN
ihlr-18810	424	155	's	's	PART
ihlr-18810	424	156	center	center	NOUN
ihlr-18810	424	157	for	for	ADP
ihlr-18810	424	158	devices	device	NOUN
ihlr-18810	424	159	and	and	CCONJ
ihlr-18810	424	160	radiological	radiological	ADJ
ihlr-18810	424	161	health	health	NOUN
ihlr-18810	424	162	seized	seize	VERB
ihlr-18810	424	163	only	only	ADV
ihlr-18810	424	164	one	one	NUM
ihlr-18810	424	165	device.174	device.174	PROPN
ihlr-18810	424	166	the	the	DET
ihlr-18810	424	167	fda	fda	PROPN
ihlr-18810	424	168	also	also	ADV
ihlr-18810	424	169	has	have	VERB
ihlr-18810	424	170	the	the	DET
ihlr-18810	424	171	authority	authority	NOUN
ihlr-18810	424	172	to	to	PART
ihlr-18810	424	173	seek	seek	VERB
ihlr-18810	424	174	injunctions	injunction	NOUN
ihlr-18810	424	175	.	.	PUNCT
ihlr-18810	425	1	75	75	NUM
ihlr-18810	425	2	168	168	NUM
ihlr-18810	425	3	i	i	PRON
ihlr-18810	425	4	d.	d.	PROPN
ihlr-18810	425	5	169	169	NUM
ihlr-18810	426	1	i	i	PROPN
ihlr-18810	426	2	d.	d.	PROPN
ihlr-18810	426	3	170	170	NUM
ihlr-18810	426	4	inspections	inspection	NOUN
ihlr-18810	426	5	,	,	PUNCT
ihlr-18810	426	6	compliance	compliance	NOUN
ihlr-18810	426	7	,	,	PUNCT
ihlr-18810	426	8	enforcement	enforcement	NOUN
ihlr-18810	426	9	,	,	PUNCT
ihlr-18810	426	10	and	and	CCONJ
ihlr-18810	426	11	criminal	criminal	ADJ
ihlr-18810	426	12	investigations	investigation	NOUN
ihlr-18810	426	13	administrative	administrative	ADJ
ihlr-18810	426	14	detention	detention	NOUN
ihlr-18810	426	15	of	of	ADP
ihlr-18810	426	16	devices	device	NOUN
ihlr-18810	426	17	,	,	PUNCT
ihlr-18810	426	18	fdagov	fdagov	NOUN
ihlr-18810	426	19	,	,	PUNCT
ihlr-18810	426	20	http://www.fda.gov/iceci/compliancemanuals/regulatoryprocedures	http://www.fda.gov/iceci/compliancemanuals/regulatoryprocedure	VERB
ihlr-18810	426	21	manuallucml76980.htm	manuallucml76980.htm	NOUN
ihlr-18810	426	22	(	(	PUNCT
ihlr-18810	426	23	last	last	ADV
ihlr-18810	426	24	visited	visit	VERB
ihlr-18810	426	25	dec	dec	PROPN
ihlr-18810	426	26	.	.	PROPN
ihlr-18810	426	27	21	21	NUM
ihlr-18810	426	28	,	,	PUNCT
ihlr-18810	426	29	2012	2012	NUM
ihlr-18810	426	30	)	)	PUNCT
ihlr-18810	426	31	.	.	PUNCT
ihlr-18810	427	1	171	171	NUM
ihlr-18810	427	2	21	21	NUM
ihlr-18810	427	3	u.s.c	u.s.c	NOUN
ihlr-18810	427	4	.	.	PUNCT
ihlr-18810	428	1	§	§	PROPN
ihlr-18810	428	2	334(a)(1	334(a)(1	NUM
ihlr-18810	428	3	)	)	PUNCT
ihlr-18810	428	4	(	(	PUNCT
ihlr-18810	428	5	2012	2012	NUM
ihlr-18810	428	6	)	)	PUNCT
ihlr-18810	428	7	.	.	PUNCT
ihlr-18810	429	1	172	172	NUM
ihlr-18810	429	2	21	21	NUM
ihlr-18810	429	3	u.s.c	u.s.c	NOUN
ihlr-18810	429	4	.	.	PUNCT
ihlr-18810	430	1	§	§	PROPN
ihlr-18810	430	2	334(d	334(d	PROPN
ihlr-18810	430	3	)	)	PUNCT
ihlr-18810	430	4	(	(	PUNCT
ihlr-18810	430	5	2012	2012	NUM
ihlr-18810	430	6	)	)	PUNCT
ihlr-18810	430	7	.	.	PUNCT
ihlr-18810	431	1	173	173	NUM
ihlr-18810	431	2	21	21	NUM
ihlr-18810	431	3	.	.	PUNCT
ihlr-18810	432	1	u.s.c	u.s.c	ADJ
ihlr-18810	432	2	.	.	PUNCT
ihlr-18810	433	1	§	§	PROPN
ihlr-18810	433	2	334(a)(1	334(a)(1	NUM
ihlr-18810	433	3	)	)	PUNCT
ihlr-18810	433	4	(	(	PUNCT
ihlr-18810	433	5	2012	2012	NUM
ihlr-18810	433	6	)	)	PUNCT
ihlr-18810	433	7	.	.	PUNCT
ihlr-18810	434	1	174	174	NUM
ihlr-18810	434	2	seizures	seizure	NOUN
ihlr-18810	434	3	by	by	ADP
ihlr-18810	434	4	fda	fda	PROPN
ihlr-18810	434	5	center	center	PROPN
ihlr-18810	434	6	fiscal	fiscal	ADJ
ihlr-18810	434	7	year	year	NOUN
ihlr-18810	434	8	2011	2011	NUM
ihlr-18810	434	9	,	,	PUNCT
ihlr-18810	434	10	fda.gov	fda.gov	NUM
ihlr-18810	434	11	,	,	PUNCT
ihlr-18810	434	12	http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781	http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781	PROPN
ihlr-18810	434	13	.	.	PUNCT
ihlr-18810	434	14	pdf	pdf	NOUN
ihlr-18810	434	15	.	.	PUNCT
ihlr-18810	435	1	175	175	NUM
ihlr-18810	435	2	21	21	NUM
ihlr-18810	435	3	u.s.c	u.s.c	NOUN
ihlr-18810	435	4	.	.	PUNCT
ihlr-18810	436	1	§	§	PROPN
ihlr-18810	436	2	332(a	332(a	PROPN
ihlr-18810	436	3	)	)	PUNCT
ihlr-18810	436	4	(	(	PUNCT
ihlr-18810	436	5	2012	2012	NUM
ihlr-18810	436	6	)	)	PUNCT
ihlr-18810	436	7	.	.	PUNCT
ihlr-18810	437	1	2013	2013	NUM
ihlr-18810	437	2	145	145	NUM
ihlr-18810	437	3	indiana	indiana	PROPN
ihlr-18810	437	4	health	health	PROPN
ihlr-18810	437	5	law	law	PROPN
ihlr-18810	437	6	review	review	VERB
ihlr-18810	437	7	the	the	DET
ihlr-18810	437	8	fdca	fdca	NOUN
ihlr-18810	437	9	provides	provide	VERB
ihlr-18810	437	10	that	that	SCONJ
ihlr-18810	437	11	courts	court	NOUN
ihlr-18810	437	12	shall	shall	AUX
ihlr-18810	437	13	have	have	VERB
ihlr-18810	437	14	jurisdiction	jurisdiction	NOUN
ihlr-18810	437	15	,	,	PUNCT
ihlr-18810	437	16	when	when	SCONJ
ihlr-18810	437	17	cause	cause	NOUN
ihlr-18810	437	18	is	be	AUX
ihlr-18810	437	19	shown	show	VERB
ihlr-18810	437	20	,	,	PUNCT
ihlr-18810	437	21	to	to	PART
ihlr-18810	437	22	restrain	restrain	VERB
ihlr-18810	437	23	violations	violation	NOUN
ihlr-18810	437	24	of	of	ADP
ihlr-18810	437	25	the	the	DET
ihlr-18810	437	26	fdca.176	fdca.176	NOUN
ihlr-18810	437	27	injunctions	injunction	NOUN
ihlr-18810	437	28	can	can	AUX
ihlr-18810	437	29	be	be	AUX
ihlr-18810	437	30	sought	seek	VERB
ihlr-18810	437	31	for	for	ADP
ihlr-18810	437	32	any	any	DET
ihlr-18810	437	33	significant	significant	ADJ
ihlr-18810	437	34	failure	failure	NOUN
ihlr-18810	437	35	to	to	PART
ihlr-18810	437	36	comply	comply	VERB
ihlr-18810	437	37	with	with	ADP
ihlr-18810	437	38	fda	fda	PROPN
ihlr-18810	437	39	regulation	regulation	PROPN
ihlr-18810	437	40	,	,	PUNCT
ihlr-18810	437	41	especially	especially	ADV
ihlr-18810	437	42	when	when	SCONJ
ihlr-18810	437	43	the	the	DET
ihlr-18810	437	44	noncompliance	noncompliance	NOUN
ihlr-18810	437	45	has	have	AUX
ihlr-18810	437	46	been	be	AUX
ihlr-18810	437	47	identified	identify	VERB
ihlr-18810	437	48	as	as	ADP
ihlr-18810	437	49	hazardous	hazardous	ADJ
ihlr-18810	437	50	to	to	ADP
ihlr-18810	437	51	health.177	health.177	PROPN
ihlr-18810	437	52	this	this	PRON
ihlr-18810	437	53	does	do	AUX
ihlr-18810	437	54	not	not	PART
ihlr-18810	437	55	happen	happen	VERB
ihlr-18810	437	56	very	very	ADV
ihlr-18810	437	57	frequently	frequently	ADV
ihlr-18810	437	58	,	,	PUNCT
ihlr-18810	437	59	however	however	ADV
ihlr-18810	437	60	,	,	PUNCT
ihlr-18810	437	61	and	and	CCONJ
ihlr-18810	437	62	in	in	ADP
ihlr-18810	437	63	fiscal	fiscal	ADJ
ihlr-18810	437	64	year	year	NOUN
ihlr-18810	437	65	2011	2011	NUM
ihlr-18810	437	66	,	,	PUNCT
ihlr-18810	437	67	no	no	DET
ihlr-18810	437	68	injunctions	injunction	NOUN
ihlr-18810	437	69	were	be	AUX
ihlr-18810	437	70	filed	file	VERB
ihlr-18810	437	71	against	against	ADP
ihlr-18810	437	72	any	any	DET
ihlr-18810	437	73	devices	device	NOUN
ihlr-18810	437	74	.	.	PUNCT
ihlr-18810	438	1	7	7	NUM
ihlr-18810	438	2	8	8	NUM
ihlr-18810	438	3	the	the	DET
ihlr-18810	438	4	timeliness	timeliness	NOUN
ihlr-18810	438	5	of	of	ADP
ihlr-18810	438	6	the	the	DET
ihlr-18810	438	7	evidence	evidence	NOUN
ihlr-18810	438	8	presented	present	VERB
ihlr-18810	438	9	in	in	ADP
ihlr-18810	438	10	support	support	NOUN
ihlr-18810	438	11	of	of	ADP
ihlr-18810	438	12	the	the	DET
ihlr-18810	438	13	injunction	injunction	NOUN
ihlr-18810	438	14	is	be	AUX
ihlr-18810	438	15	critically	critically	ADV
ihlr-18810	438	16	important	important	ADJ
ihlr-18810	438	17	;	;	PUNCT
ihlr-18810	438	18	the	the	DET
ihlr-18810	438	19	currentness	currentness	NOUN
ihlr-18810	438	20	of	of	ADP
ihlr-18810	438	21	the	the	DET
ihlr-18810	438	22	information	information	NOUN
ihlr-18810	438	23	makes	make	VERB
ihlr-18810	438	24	the	the	DET
ihlr-18810	438	25	action	action	NOUN
ihlr-18810	438	26	credible	credible	ADJ
ihlr-18810	438	27	and	and	CCONJ
ihlr-18810	438	28	limitations	limitation	NOUN
ihlr-18810	438	29	on	on	ADP
ihlr-18810	438	30	the	the	DET
ihlr-18810	438	31	need	need	NOUN
ihlr-18810	438	32	to	to	PART
ihlr-18810	438	33	update	update	VERB
ihlr-18810	438	34	the	the	DET
ihlr-18810	438	35	evidence	evidence	NOUN
ihlr-18810	438	36	are	be	AUX
ihlr-18810	438	37	important.179	important.179	NOUN
ihlr-18810	438	38	courts	court	NOUN
ihlr-18810	438	39	will	will	AUX
ihlr-18810	438	40	,	,	PUNCT
ihlr-18810	438	41	in	in	ADP
ihlr-18810	438	42	considering	consider	VERB
ihlr-18810	438	43	an	an	DET
ihlr-18810	438	44	injunction	injunction	NOUN
ihlr-18810	438	45	,	,	PUNCT
ihlr-18810	438	46	evaluate	evaluate	VERB
ihlr-18810	438	47	the	the	DET
ihlr-18810	438	48	seriousness	seriousness	NOUN
ihlr-18810	438	49	of	of	ADP
ihlr-18810	438	50	the	the	DET
ihlr-18810	438	51	offense	offense	NOUN
ihlr-18810	438	52	,	,	PUNCT
ihlr-18810	438	53	the	the	DET
ihlr-18810	438	54	potential	potential	ADJ
ihlr-18810	438	55	impact	impact	NOUN
ihlr-18810	438	56	to	to	ADP
ihlr-18810	438	57	the	the	DET
ihlr-18810	438	58	public	public	NOUN
ihlr-18810	438	59	,	,	PUNCT
ihlr-18810	438	60	whether	whether	SCONJ
ihlr-18810	438	61	alternative	alternative	ADJ
ihlr-18810	438	62	corrective	corrective	ADJ
ihlr-18810	438	63	actions	action	NOUN
ihlr-18810	438	64	could	could	AUX
ihlr-18810	438	65	be	be	AUX
ihlr-18810	438	66	as	as	ADV
ihlr-18810	438	67	effective	effective	ADJ
ihlr-18810	438	68	as	as	ADP
ihlr-18810	438	69	an	an	DET
ihlr-18810	438	70	injunction	injunction	NOUN
ihlr-18810	438	71	,	,	PUNCT
ihlr-18810	438	72	and	and	CCONJ
ihlr-18810	438	73	whether	whether	SCONJ
ihlr-18810	438	74	there	there	PRON
ihlr-18810	438	75	is	be	VERB
ihlr-18810	438	76	a	a	DET
ihlr-18810	438	77	likelihood	likelihood	NOUN
ihlr-18810	438	78	of	of	ADP
ihlr-18810	438	79	continued	continue	VERB
ihlr-18810	438	80	violation	violation	NOUN
ihlr-18810	438	81	of	of	ADP
ihlr-18810	438	82	fda	fda	PROPN
ihlr-18810	438	83	regulations	regulation	NOUN
ihlr-18810	438	84	in	in	ADP
ihlr-18810	438	85	the	the	DET
ihlr-18810	438	86	absence	absence	NOUN
ihlr-18810	438	87	of	of	ADP
ihlr-18810	438	88	an	an	DET
ihlr-18810	438	89	injunction.o8	injunction.o8	PROPN
ihlr-18810	438	90	0	0	NUM
ihlr-18810	438	91	injunctions	injunction	NOUN
ihlr-18810	438	92	are	be	AUX
ihlr-18810	438	93	best	well	ADV
ihlr-18810	438	94	suited	suit	VERB
ihlr-18810	438	95	for	for	ADP
ihlr-18810	438	96	situations	situation	NOUN
ihlr-18810	438	97	where	where	SCONJ
ihlr-18810	438	98	a	a	DET
ihlr-18810	438	99	definite	definite	ADJ
ihlr-18810	438	100	health	health	NOUN
ihlr-18810	438	101	hazard	hazard	NOUN
ihlr-18810	438	102	or	or	CCONJ
ihlr-18810	438	103	strong	strong	ADJ
ihlr-18810	438	104	consumer	consumer	NOUN
ihlr-18810	438	105	deception	deception	NOUN
ihlr-18810	438	106	with	with	ADP
ihlr-18810	438	107	regard	regard	NOUN
ihlr-18810	438	108	to	to	ADP
ihlr-18810	438	109	the	the	DET
ihlr-18810	438	110	device	device	NOUN
ihlr-18810	438	111	exists	exist	VERB
ihlr-18810	438	112	,	,	PUNCT
ihlr-18810	438	113	when	when	SCONJ
ihlr-18810	438	114	recall	recall	VERB
ihlr-18810	438	115	or	or	CCONJ
ihlr-18810	438	116	seizure	seizure	NOUN
ihlr-18810	438	117	is	be	AUX
ihlr-18810	438	118	impractical	impractical	ADJ
ihlr-18810	438	119	,	,	PUNCT
ihlr-18810	438	120	or	or	CCONJ
ihlr-18810	438	121	when	when	SCONJ
ihlr-18810	438	122	the	the	DET
ihlr-18810	438	123	noncompliant	noncompliant	ADJ
ihlr-18810	438	124	practices	practice	NOUN
ihlr-18810	438	125	are	be	AUX
ihlr-18810	438	126	long	long	ADV
ihlr-18810	438	127	-	-	PUNCT
ihlr-18810	438	128	standing	stand	VERB
ihlr-18810	438	129	and	and	CCONJ
ihlr-18810	438	130	previously	previously	ADV
ihlr-18810	438	131	uncorrected	uncorrecte	VERB
ihlr-18810	438	132	by	by	ADP
ihlr-18810	438	133	other	other	ADJ
ihlr-18810	438	134	means	mean	NOUN
ihlr-18810	438	135	.	.	PUNCT
ihlr-18810	439	1	181	181	NUM
ihlr-18810	439	2	seeking	seek	VERB
ihlr-18810	439	3	an	an	DET
ihlr-18810	439	4	injunction	injunction	NOUN
ihlr-18810	439	5	does	do	AUX
ihlr-18810	439	6	not	not	PART
ihlr-18810	439	7	preclude	preclude	VERB
ihlr-18810	439	8	any	any	PRON
ihlr-18810	439	9	of	of	ADP
ihlr-18810	439	10	the	the	DET
ihlr-18810	439	11	other	other	ADJ
ihlr-18810	439	12	enforcement	enforcement	NOUN
ihlr-18810	439	13	mechanisms	mechanism	NOUN
ihlr-18810	439	14	available	available	ADJ
ihlr-18810	439	15	to	to	ADP
ihlr-18810	439	16	the	the	DET
ihlr-18810	439	17	fda	fda	PROPN
ihlr-18810	439	18	.	.	PUNCT
ihlr-18810	440	1	this	this	DET
ihlr-18810	440	2	enforcement	enforcement	NOUN
ihlr-18810	440	3	mechanism	mechanism	NOUN
ihlr-18810	440	4	will	will	AUX
ihlr-18810	440	5	be	be	AUX
ihlr-18810	440	6	helpful	helpful	ADJ
ihlr-18810	440	7	for	for	ADP
ihlr-18810	440	8	510(k	510(k	PROPN
ihlr-18810	440	9	)	)	PUNCT
ihlr-18810	440	10	cleared	clear	VERB
ihlr-18810	440	11	devices	device	NOUN
ihlr-18810	440	12	rendered	render	VERB
ihlr-18810	440	13	unsafe	unsafe	ADJ
ihlr-18810	440	14	due	due	ADJ
ihlr-18810	440	15	to	to	ADP
ihlr-18810	440	16	failures	failure	NOUN
ihlr-18810	440	17	in	in	ADP
ihlr-18810	440	18	gmp	gmp	PROPN
ihlr-18810	440	19	,	,	PUNCT
ihlr-18810	440	20	labeling	labeling	NOUN
ihlr-18810	440	21	,	,	PUNCT
ihlr-18810	440	22	or	or	CCONJ
ihlr-18810	440	23	instruction	instruction	NOUN
ihlr-18810	440	24	,	,	PUNCT
ihlr-18810	440	25	but	but	CCONJ
ihlr-18810	440	26	it	it	PRON
ihlr-18810	440	27	will	will	AUX
ihlr-18810	440	28	not	not	PART
ihlr-18810	440	29	be	be	AUX
ihlr-18810	440	30	helpful	helpful	ADJ
ihlr-18810	440	31	in	in	ADP
ihlr-18810	440	32	removing	remove	VERB
ihlr-18810	440	33	devices	device	NOUN
ihlr-18810	440	34	found	find	VERB
ihlr-18810	440	35	to	to	PART
ihlr-18810	440	36	be	be	AUX
ihlr-18810	440	37	substantially	substantially	ADV
ihlr-18810	440	38	equivalent	equivalent	ADJ
ihlr-18810	440	39	to	to	ADP
ihlr-18810	440	40	pre-1976	pre-1976	NOUN
ihlr-18810	440	41	devices	device	NOUN
ihlr-18810	440	42	,	,	PUNCT
ihlr-18810	440	43	because	because	SCONJ
ihlr-18810	440	44	no	no	DET
ihlr-18810	440	45	regulations	regulation	NOUN
ihlr-18810	440	46	pertaining	pertain	VERB
ihlr-18810	440	47	to	to	ADP
ihlr-18810	440	48	176	176	NUM
ihlr-18810	440	49	21	21	NUM
ihlr-18810	440	50	u.s.c	u.s.c	NOUN
ihlr-18810	440	51	.	.	PUNCT
ihlr-18810	441	1	§	§	PROPN
ihlr-18810	441	2	332(a	332(a	PROPN
ihlr-18810	441	3	)	)	PUNCT
ihlr-18810	441	4	(	(	PUNCT
ihlr-18810	441	5	2012	2012	NUM
ihlr-18810	441	6	)	)	PUNCT
ihlr-18810	441	7	;	;	PUNCT
ihlr-18810	441	8	see	see	VERB
ihlr-18810	441	9	also	also	ADV
ihlr-18810	441	10	21	21	NUM
ihlr-18810	441	11	u.s.c	u.s.c	ADJ
ihlr-18810	441	12	.	.	PUNCT
ihlr-18810	442	1	§	§	PROPN
ihlr-18810	442	2	331	331	NUM
ihlr-18810	442	3	(	(	PUNCT
ihlr-18810	442	4	2012	2012	NUM
ihlr-18810	442	5	)	)	PUNCT
ihlr-18810	442	6	(	(	PUNCT
ihlr-18810	442	7	enumerating	enumerate	VERB
ihlr-18810	442	8	prohibited	prohibit	VERB
ihlr-18810	442	9	acts	act	NOUN
ihlr-18810	442	10	)	)	PUNCT
ihlr-18810	442	11	.	.	PUNCT
ihlr-18810	443	1	177	177	NUM
ihlr-18810	443	2	inspections	inspection	NOUN
ihlr-18810	443	3	,	,	PUNCT
ihlr-18810	443	4	compliance	compliance	NOUN
ihlr-18810	443	5	,	,	PUNCT
ihlr-18810	443	6	enforcement	enforcement	NOUN
ihlr-18810	443	7	,	,	PUNCT
ihlr-18810	443	8	and	and	CCONJ
ihlr-18810	443	9	criminal	criminal	ADJ
ihlr-18810	443	10	investigations	investigation	NOUN
ihlr-18810	443	11	injunctions	injunction	NOUN
ihlr-18810	443	12	,	,	PUNCT
ihlr-18810	443	13	fda.gov	fda.gov	NUM
ihlr-18810	443	14	,	,	PUNCT
ihlr-18810	443	15	http://www.fda.gov/icecii	http://www.fda.gov/icecii	PROPN
ihlr-18810	443	16	compliancemanuals	compliancemanual	NOUN
ihlr-18810	443	17	/	/	SYM
ihlr-18810	443	18	regulatoryproceduresmanuallucml76734.htm	regulatoryproceduresmanuallucml76734.htm	NOUN
ihlr-18810	443	19	(	(	PUNCT
ihlr-18810	443	20	last	last	ADV
ihlr-18810	443	21	visited	visit	VERB
ihlr-18810	443	22	dec	dec	PROPN
ihlr-18810	443	23	.	.	PROPN
ihlr-18810	443	24	21	21	NUM
ihlr-18810	443	25	,	,	PUNCT
ihlr-18810	443	26	2012	2012	NUM
ihlr-18810	443	27	)	)	PUNCT
ihlr-18810	444	1	[	[	X
ihlr-18810	444	2	hereinafter	hereinafter	NOUN
ihlr-18810	444	3	injunctions	injunction	NOUN
ihlr-18810	444	4	]	]	PUNCT
ihlr-18810	444	5	.	.	PUNCT
ihlr-18810	445	1	178	178	NUM
ihlr-18810	445	2	injunctions	injunction	NOUN
ihlr-18810	445	3	by	by	ADP
ihlr-18810	445	4	fda	fda	PROPN
ihlr-18810	445	5	center	center	PROPN
ihlr-18810	445	6	iscal	iscal	ADJ
ihlr-18810	445	7	year	year	NOUN
ihlr-18810	445	8	2011	2011	NUM
ihlr-18810	445	9	,	,	PUNCT
ihlr-18810	445	10	fda.gov	fda.gov	NUM
ihlr-18810	445	11	,	,	PUNCT
ihlr-18810	445	12	http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781	http://www.fda.gov/downloads/iceci/enforcementactions/ucm285781	PROPN
ihlr-18810	445	13	.	.	PUNCT
ihlr-18810	445	14	pdf	pdf	NOUN
ihlr-18810	445	15	.	.	PUNCT
ihlr-18810	446	1	179	179	NUM
ihlr-18810	446	2	injunctions	injunction	NOUN
ihlr-18810	446	3	,	,	PUNCT
ihlr-18810	446	4	supra	supra	PROPN
ihlr-18810	446	5	note	note	NOUN
ihlr-18810	446	6	178	178	NUM
ihlr-18810	446	7	.	.	PUNCT
ihlr-18810	447	1	180	180	NUM
ihlr-18810	447	2	i	i	NOUN
ihlr-18810	447	3	d	d	PROPN
ihlr-18810	447	4	181	181	NUM
ihlr-18810	448	1	i	i	NOUN
ihlr-18810	448	2	d	d	PROPN
ihlr-18810	448	3	146	146	NUM
ihlr-18810	448	4	vol	vol	NOUN
ihlr-18810	448	5	.	.	PUNCT
ihlr-18810	449	1	10:1	10:1	NUM
ihlr-18810	449	2	510(k	510(k	X
ihlr-18810	449	3	)	)	PUNCT
ihlr-18810	449	4	clearance	clearance	NOUN
ihlr-18810	449	5	product	product	NOUN
ihlr-18810	449	6	design	design	NOUN
ihlr-18810	449	7	have	have	AUX
ihlr-18810	449	8	been	be	AUX
ihlr-18810	449	9	imposed	impose	VERB
ihlr-18810	449	10	which	which	PRON
ihlr-18810	449	11	can	can	AUX
ihlr-18810	449	12	be	be	AUX
ihlr-18810	449	13	violated	violate	VERB
ihlr-18810	449	14	.	.	PUNCT
ihlr-18810	450	1	182	182	NUM
ihlr-18810	450	2	finally	finally	ADV
ihlr-18810	450	3	,	,	PUNCT
ihlr-18810	450	4	the	the	DET
ihlr-18810	450	5	fda	fda	PROPN
ihlr-18810	450	6	is	be	AUX
ihlr-18810	450	7	able	able	ADJ
ihlr-18810	450	8	to	to	PART
ihlr-18810	450	9	report	report	VERB
ihlr-18810	450	10	violations	violation	NOUN
ihlr-18810	450	11	to	to	ADP
ihlr-18810	450	12	the	the	DET
ihlr-18810	450	13	department	department	PROPN
ihlr-18810	450	14	of	of	ADP
ihlr-18810	450	15	justice	justice	PROPN
ihlr-18810	450	16	(	(	PUNCT
ihlr-18810	450	17	doj	doj	PROPN
ihlr-18810	450	18	)	)	PUNCT
ihlr-18810	450	19	for	for	ADP
ihlr-18810	450	20	criminal	criminal	ADJ
ihlr-18810	450	21	prosecution	prosecution	NOUN
ihlr-18810	450	22	.	.	PUNCT
ihlr-18810	451	1	the	the	DET
ihlr-18810	451	2	fdca	fdca	NOUN
ihlr-18810	451	3	provides	provide	VERB
ihlr-18810	451	4	penalties	penalty	NOUN
ihlr-18810	451	5	for	for	ADP
ihlr-18810	451	6	violations	violation	NOUN
ihlr-18810	451	7	of	of	ADP
ihlr-18810	451	8	the	the	DET
ihlr-18810	451	9	act	act	NOUN
ihlr-18810	451	10	,	,	PUNCT
ihlr-18810	451	11	including	include	VERB
ihlr-18810	451	12	one	one	NUM
ihlr-18810	451	13	year	year	NOUN
ihlr-18810	451	14	's	's	PART
ihlr-18810	451	15	imprisonment	imprisonment	NOUN
ihlr-18810	451	16	andlor	andlor	NOUN
ihlr-18810	451	17	fines	fine	NOUN
ihlr-18810	451	18	up	up	ADP
ihlr-18810	451	19	to	to	PART
ihlr-18810	451	20	$	$	SYM
ihlr-18810	451	21	1,000	1,000	NUM
ihlr-18810	451	22	for	for	ADP
ihlr-18810	451	23	first	first	ADJ
ihlr-18810	451	24	time	time	NOUN
ihlr-18810	451	25	or	or	CCONJ
ihlr-18810	451	26	unintentional	unintentional	ADJ
ihlr-18810	451	27	violations	violation	NOUN
ihlr-18810	451	28	,	,	PUNCT
ihlr-18810	451	29	and	and	CCONJ
ihlr-18810	451	30	three	three	NUM
ihlr-18810	451	31	years	year	NOUN
ihlr-18810	451	32	imprisonment	imprisonment	NOUN
ihlr-18810	451	33	andlor	andlor	VERB
ihlr-18810	451	34	a	a	DET
ihlr-18810	451	35	$	$	SYM
ihlr-18810	451	36	10,000	10,000	NUM
ihlr-18810	451	37	fine	fine	NOUN
ihlr-18810	451	38	for	for	ADP
ihlr-18810	451	39	intentional	intentional	ADJ
ihlr-18810	451	40	or	or	CCONJ
ihlr-18810	451	41	repeated	repeat	VERB
ihlr-18810	451	42	violations	violation	NOUN
ihlr-18810	451	43	.	.	PUNCT
ihlr-18810	452	1	183	183	NUM
ihlr-18810	452	2	before	before	SCONJ
ihlr-18810	452	3	a	a	DET
ihlr-18810	452	4	punishment	punishment	NOUN
ihlr-18810	452	5	of	of	ADP
ihlr-18810	452	6	this	this	DET
ihlr-18810	452	7	nature	nature	NOUN
ihlr-18810	452	8	may	may	AUX
ihlr-18810	452	9	be	be	AUX
ihlr-18810	452	10	imposed	impose	VERB
ihlr-18810	452	11	,	,	PUNCT
ihlr-18810	452	12	due	due	ADJ
ihlr-18810	452	13	process	process	NOUN
ihlr-18810	452	14	requires	require	VERB
ihlr-18810	452	15	that	that	SCONJ
ihlr-18810	452	16	any	any	DET
ihlr-18810	452	17	potential	potential	ADJ
ihlr-18810	452	18	defendant	defendant	NOUN
ihlr-18810	452	19	have	have	VERB
ihlr-18810	452	20	notice	notice	NOUN
ihlr-18810	452	21	and	and	CCONJ
ihlr-18810	452	22	an	an	DET
ihlr-18810	452	23	op	op	NOUN
ihlr-18810	452	24	-	-	PUNCT
ihlr-18810	452	25	portunity	portunity	NOUN
ihlr-18810	452	26	to	to	PART
ihlr-18810	452	27	present	present	VERB
ihlr-18810	452	28	their	their	PRON
ihlr-18810	452	29	own	own	ADJ
ihlr-18810	452	30	facts	fact	NOUN
ihlr-18810	452	31	.	.	PUNCT
ihlr-18810	453	1	184	184	NUM
ihlr-18810	453	2	"	"	PUNCT
ihlr-18810	453	3	the	the	DET
ihlr-18810	453	4	office	office	NOUN
ihlr-18810	453	5	of	of	ADP
ihlr-18810	453	6	criminal	criminal	ADJ
ihlr-18810	453	7	investigations	investigation	NOUN
ihlr-18810	453	8	(	(	PUNCT
ihlr-18810	453	9	oci	oci	X
ihlr-18810	453	10	)	)	PUNCT
ihlr-18810	453	11	is	be	AUX
ihlr-18810	453	12	responsible	responsible	ADJ
ihlr-18810	453	13	for	for	ADP
ihlr-18810	453	14	reviewing	review	VERB
ihlr-18810	453	15	all	all	DET
ihlr-18810	453	16	fda	fda	PROPN
ihlr-18810	453	17	matters	matter	VERB
ihlr-18810	453	18	for	for	ADP
ihlr-18810	453	19	which	which	PRON
ihlr-18810	453	20	a	a	DET
ihlr-18810	453	21	criminal	criminal	ADJ
ihlr-18810	453	22	investigation	investigation	NOUN
ihlr-18810	453	23	is	be	AUX
ihlr-18810	453	24	recommended	recommend	VERB
ihlr-18810	453	25	.	.	PUNCT
ihlr-18810	454	1	"1	"1	NOUN
ihlr-18810	454	2	8	8	NUM
ihlr-18810	454	3	5	5	NUM
ihlr-18810	454	4	if	if	SCONJ
ihlr-18810	454	5	,	,	PUNCT
ihlr-18810	454	6	upon	upon	SCONJ
ihlr-18810	454	7	review	review	NOUN
ihlr-18810	454	8	of	of	ADP
ihlr-18810	454	9	the	the	DET
ihlr-18810	454	10	all	all	PRON
ihlr-18810	454	11	of	of	ADP
ihlr-18810	454	12	the	the	DET
ihlr-18810	454	13	available	available	ADJ
ihlr-18810	454	14	information	information	NOUN
ihlr-18810	454	15	,	,	PUNCT
ihlr-18810	454	16	the	the	DET
ihlr-18810	454	17	oci	oci	PROPN
ihlr-18810	454	18	decides	decide	VERB
ihlr-18810	454	19	that	that	SCONJ
ihlr-18810	454	20	the	the	DET
ihlr-18810	454	21	request	request	NOUN
ihlr-18810	454	22	for	for	ADP
ihlr-18810	454	23	a	a	DET
ihlr-18810	454	24	criminal	criminal	ADJ
ihlr-18810	454	25	investigation	investigation	NOUN
ihlr-18810	454	26	should	should	AUX
ihlr-18810	454	27	be	be	AUX
ihlr-18810	454	28	referred	refer	VERB
ihlr-18810	454	29	,	,	PUNCT
ihlr-18810	454	30	it	it	PRON
ihlr-18810	454	31	will	will	AUX
ihlr-18810	454	32	be	be	AUX
ihlr-18810	454	33	referred	refer	VERB
ihlr-18810	454	34	to	to	ADP
ihlr-18810	454	35	the	the	DET
ihlr-18810	454	36	oci	oci	NOUN
ihlr-18810	454	37	's	's	PART
ihlr-18810	454	38	office	office	NOUN
ihlr-18810	454	39	of	of	ADP
ihlr-18810	454	40	the	the	DET
ihlr-18810	454	41	chief	chief	ADJ
ihlr-18810	454	42	counsel	counsel	NOUN
ihlr-18810	454	43	,	,	PUNCT
ihlr-18810	454	44	where	where	SCONJ
ihlr-18810	454	45	documents	document	NOUN
ihlr-18810	454	46	will	will	AUX
ihlr-18810	454	47	be	be	AUX
ihlr-18810	454	48	prepared	prepare	VERB
ihlr-18810	454	49	before	before	ADP
ihlr-18810	454	50	being	be	AUX
ihlr-18810	454	51	forwarded	forward	VERB
ihlr-18810	454	52	to	to	ADP
ihlr-18810	454	53	the	the	DET
ihlr-18810	454	54	doj.186	doj.186	PROPN
ihlr-18810	454	55	c.	c.	NOUN
ihlr-18810	454	56	when	when	SCONJ
ihlr-18810	454	57	the	the	DET
ihlr-18810	454	58	regulatory	regulatory	ADJ
ihlr-18810	454	59	process	process	NOUN
ihlr-18810	454	60	fails	fail	VERB
ihlr-18810	454	61	:	:	PUNCT
ihlr-18810	454	62	'	'	PUNCT
ihlr-18810	454	63	the	the	DET
ihlr-18810	454	64	tort	tort	NOUN
ihlr-18810	454	65	system	system	NOUN
ihlr-18810	454	66	the	the	DET
ihlr-18810	454	67	primary	primary	ADJ
ihlr-18810	454	68	reason	reason	NOUN
ihlr-18810	454	69	for	for	ADP
ihlr-18810	454	70	the	the	DET
ihlr-18810	454	71	enactment	enactment	NOUN
ihlr-18810	454	72	of	of	ADP
ihlr-18810	454	73	the	the	DET
ihlr-18810	454	74	fdca	fdca	NOUN
ihlr-18810	454	75	and	and	CCONJ
ihlr-18810	454	76	the	the	DET
ihlr-18810	454	77	mda	mda	PROPN
ihlr-18810	454	78	and	and	CCONJ
ihlr-18810	454	79	the	the	DET
ihlr-18810	454	80	creation	creation	NOUN
ihlr-18810	454	81	of	of	ADP
ihlr-18810	454	82	the	the	DET
ihlr-18810	454	83	fda	fda	PROPN
ihlr-18810	454	84	was	be	AUX
ihlr-18810	454	85	to	to	PART
ihlr-18810	454	86	protect	protect	VERB
ihlr-18810	454	87	consumers	consumer	NOUN
ihlr-18810	454	88	of	of	ADP
ihlr-18810	454	89	medical	medical	ADJ
ihlr-18810	454	90	drugs	drug	NOUN
ihlr-18810	454	91	and	and	CCONJ
ihlr-18810	454	92	devices	device	NOUN
ihlr-18810	454	93	.	.	PUNCT
ihlr-18810	455	1	the	the	DET
ihlr-18810	455	2	fda	fda	PROPN
ihlr-18810	455	3	does	do	AUX
ihlr-18810	455	4	not	not	PART
ihlr-18810	455	5	act	act	VERB
ihlr-18810	455	6	alone	alone	ADV
ihlr-18810	455	7	in	in	ADP
ihlr-18810	455	8	protecting	protect	VERB
ihlr-18810	455	9	consumers	consumer	NOUN
ihlr-18810	455	10	,	,	PUNCT
ihlr-18810	455	11	however	however	ADV
ihlr-18810	455	12	.	.	PUNCT
ihlr-18810	456	1	the	the	DET
ihlr-18810	456	2	tort	tort	NOUN
ihlr-18810	456	3	system	system	NOUN
ihlr-18810	456	4	also	also	ADV
ihlr-18810	456	5	seeks	seek	VERB
ihlr-18810	456	6	to	to	PART
ihlr-18810	456	7	protect	protect	VERB
ihlr-18810	456	8	consumers	consumer	NOUN
ihlr-18810	456	9	of	of	ADP
ihlr-18810	456	10	medical	medical	ADJ
ihlr-18810	456	11	products	product	NOUN
ihlr-18810	456	12	by	by	ADP
ihlr-18810	456	13	providing	provide	VERB
ihlr-18810	456	14	compensation	compensation	NOUN
ihlr-18810	456	15	to	to	ADP
ihlr-18810	456	16	those	those	PRON
ihlr-18810	456	17	harmed	harm	VERB
ihlr-18810	456	18	by	by	ADP
ihlr-18810	456	19	defective	defective	ADJ
ihlr-18810	456	20	products	product	NOUN
ihlr-18810	456	21	,	,	PUNCT
ihlr-18810	456	22	as	as	ADV
ihlr-18810	456	23	well	well	ADV
ihlr-18810	456	24	as	as	ADP
ihlr-18810	456	25	providing	provide	VERB
ihlr-18810	456	26	incentives	incentive	NOUN
ihlr-18810	456	27	for	for	ADP
ihlr-18810	456	28	manufacturers	manufacturer	NOUN
ihlr-18810	456	29	182	182	NUM
ihlr-18810	456	30	compare	compare	ADJ
ihlr-18810	456	31	medical	medical	ADJ
ihlr-18810	456	32	devices	device	NOUN
ihlr-18810	456	33	:	:	PUNCT
ihlr-18810	456	34	premarket	premarket	NOUN
ihlr-18810	456	35	approvals	approval	NOUN
ihlr-18810	456	36	,	,	PUNCT
ihlr-18810	456	37	u.s	u.s	PROPN
ihlr-18810	456	38	.	.	PROPN
ihlr-18810	456	39	food	food	NOUN
ihlr-18810	456	40	and	and	CCONJ
ihlr-18810	456	41	drug	drug	NOUN
ihlr-18810	456	42	admin	admin	PROPN
ihlr-18810	456	43	.	.	PROPN
ihlr-18810	456	44	,	,	PUNCT
ihlr-18810	456	45	http://www.fda.gov/medicaldevices/productsandmedical	http://www.fda.gov/medicaldevices/productsandmedical	PROPN
ihlr-18810	456	46	procedures	procedure	NOUN
ihlr-18810	456	47	/	/	SYM
ihlr-18810	456	48	deviceapprovalsandclearances	deviceapprovalsandclearance	NOUN
ihlr-18810	456	49	/	/	SYM
ihlr-18810	456	50	pmaapprovals	pmaapproval	NOUN
ihlr-18810	456	51	/	/	SYM
ihlr-18810	456	52	default.htm	default.htm	X
ihlr-18810	456	53	(	(	PUNCT
ihlr-18810	456	54	last	last	ADV
ihlr-18810	456	55	visited	visit	VERB
ihlr-18810	456	56	nov	nov	PROPN
ihlr-18810	456	57	.	.	PROPN
ihlr-18810	456	58	26	26	NUM
ihlr-18810	456	59	,	,	PUNCT
ihlr-18810	456	60	2012	2012	NUM
ihlr-18810	456	61	)	)	PUNCT
ihlr-18810	456	62	with	with	ADP
ihlr-18810	456	63	fda	fda	PROPN
ihlr-18810	456	64	,	,	PUNCT
ihlr-18810	456	65	medical	medical	ADJ
ihlr-18810	456	66	devices	device	NOUN
ihlr-18810	456	67	:	:	PUNCT
ihlr-18810	456	68	premarket	premarket	NOUN
ihlr-18810	456	69	notification	notification	NOUN
ihlr-18810	456	70	(	(	PUNCT
ihlr-18810	456	71	510k	510k	PROPN
ihlr-18810	456	72	)	)	PUNCT
ihlr-18810	456	73	,	,	PUNCT
ihlr-18810	456	74	http://www.da.gov/medicaldevices/deviceregulationand	http://www.da.gov/medicaldevices/deviceregulationand	NOUN
ihlr-18810	456	75	guidance	guidance	NOUN
ihlr-18810	456	76	/	/	SYM
ihlr-18810	456	77	howtomarketyourdevicepremarketsubmissions	howtomarketyourdevicepremarketsubmission	NOUN
ihlr-18810	456	78	/	/	SYM
ihlr-18810	456	79	premarketnotification	premarketnotification	NOUN
ihlr-18810	456	80	510k	510k	PROPN
ihlr-18810	456	81	/	/	SYM
ihlr-18810	456	82	default.htm	default.htm	PROPN
ihlr-18810	456	83	183	183	NUM
ihlr-18810	456	84	21	21	NUM
ihlr-18810	456	85	u.s.c	u.s.c	NOUN
ihlr-18810	456	86	.	.	PUNCT
ihlr-18810	457	1	§	§	PROPN
ihlr-18810	457	2	333(a	333(a	PROPN
ihlr-18810	457	3	)	)	PUNCT
ihlr-18810	457	4	(	(	PUNCT
ihlr-18810	457	5	2012	2012	NUM
ihlr-18810	457	6	)	)	PUNCT
ihlr-18810	457	7	.	.	PUNCT
ihlr-18810	458	1	184	184	NUM
ihlr-18810	458	2	21	21	NUM
ihlr-18810	458	3	u.s.c	u.s.c	NOUN
ihlr-18810	458	4	.	.	PUNCT
ihlr-18810	459	1	§	§	PROPN
ihlr-18810	459	2	335	335	NUM
ihlr-18810	459	3	(	(	PUNCT
ihlr-18810	459	4	2012	2012	NUM
ihlr-18810	459	5	)	)	PUNCT
ihlr-18810	459	6	.	.	PUNCT
ihlr-18810	460	1	185	185	NUM
ihlr-18810	460	2	inspections	inspection	NOUN
ihlr-18810	460	3	,	,	PUNCT
ihlr-18810	460	4	compliance	compliance	NOUN
ihlr-18810	460	5	,	,	PUNCT
ihlr-18810	460	6	enforcement	enforcement	NOUN
ihlr-18810	460	7	,	,	PUNCT
ihlr-18810	460	8	and	and	CCONJ
ihlr-18810	460	9	criminal	criminal	ADJ
ihlr-18810	460	10	investigations	investigation	NOUN
ihlr-18810	460	11	prosecution	prosecution	NOUN
ihlr-18810	460	12	,	,	PUNCT
ihlr-18810	460	13	fda.gov	fda.gov	NUM
ihlr-18810	460	14	,	,	PUNCT
ihlr-18810	460	15	http://www.fda.gov/iceci/	http://www.fda.gov/iceci/	PROPN
ihlr-18810	460	16	compliancemanuals	compliancemanual	NOUN
ihlr-18810	460	17	/	/	SYM
ihlr-18810	460	18	regulatoryproceduresmanuallucml76738.htm	regulatoryproceduresmanuallucml76738.htm	PROPN
ihlr-18810	460	19	(	(	PUNCT
ihlr-18810	460	20	last	last	ADV
ihlr-18810	460	21	visited	visit	VERB
ihlr-18810	460	22	dec	dec	PROPN
ihlr-18810	460	23	.	.	PROPN
ihlr-18810	460	24	21	21	NUM
ihlr-18810	460	25	,	,	PUNCT
ihlr-18810	460	26	2012	2012	NUM
ihlr-18810	460	27	)	)	PUNCT
ihlr-18810	460	28	.	.	PUNCT
ihlr-18810	461	1	186	186	NUM
ihlr-18810	462	1	i	i	PRON
ihlr-18810	462	2	d.	d.	PROPN
ihlr-18810	462	3	2013	2013	NUM
ihlr-18810	462	4	147	147	NUM
ihlr-18810	462	5	indiana	indiana	PROPN
ihlr-18810	462	6	health	health	PROPN
ihlr-18810	462	7	law	law	PROPN
ihlr-18810	462	8	review	review	NOUN
ihlr-18810	462	9	to	to	PART
ihlr-18810	462	10	design	design	VERB
ihlr-18810	462	11	safe	safe	ADJ
ihlr-18810	462	12	products.1	products.1	NOUN
ihlr-18810	462	13	87	87	NUM
ihlr-18810	462	14	the	the	DET
ihlr-18810	462	15	administrative	administrative	ADJ
ihlr-18810	462	16	and	and	CCONJ
ihlr-18810	462	17	tort	tort	NOUN
ihlr-18810	462	18	systems	system	NOUN
ihlr-18810	462	19	can	can	AUX
ihlr-18810	462	20	work	work	VERB
ihlr-18810	462	21	together	together	ADV
ihlr-18810	462	22	to	to	PART
ihlr-18810	462	23	protect	protect	VERB
ihlr-18810	462	24	consumers	consumer	NOUN
ihlr-18810	462	25	;	;	PUNCT
ihlr-18810	462	26	the	the	DET
ihlr-18810	462	27	fda	fda	PROPN
ihlr-18810	462	28	can	can	AUX
ihlr-18810	462	29	impose	impose	VERB
ihlr-18810	462	30	a	a	DET
ihlr-18810	462	31	risk	risk	NOUN
ihlr-18810	462	32	/	/	SYM
ihlr-18810	462	33	benefit	benefit	NOUN
ihlr-18810	462	34	analysis	analysis	NOUN
ihlr-18810	462	35	before	before	SCONJ
ihlr-18810	462	36	the	the	DET
ihlr-18810	462	37	product	product	NOUN
ihlr-18810	462	38	can	can	AUX
ihlr-18810	462	39	go	go	VERB
ihlr-18810	462	40	to	to	ADP
ihlr-18810	462	41	market	market	NOUN
ihlr-18810	462	42	,	,	PUNCT
ihlr-18810	462	43	setting	set	VERB
ihlr-18810	462	44	a	a	DET
ihlr-18810	462	45	floor	floor	NOUN
ihlr-18810	462	46	for	for	ADP
ihlr-18810	462	47	product	product	NOUN
ihlr-18810	462	48	safety	safety	NOUN
ihlr-18810	462	49	,	,	PUNCT
ihlr-18810	462	50	and	and	CCONJ
ihlr-18810	462	51	the	the	DET
ihlr-18810	462	52	tort	tort	NOUN
ihlr-18810	462	53	system	system	NOUN
ihlr-18810	462	54	can	can	AUX
ihlr-18810	462	55	incentivize	incentivize	VERB
ihlr-18810	462	56	manufacturers	manufacturer	NOUN
ihlr-18810	462	57	to	to	PART
ihlr-18810	462	58	make	make	VERB
ihlr-18810	462	59	products	product	NOUN
ihlr-18810	462	60	increasingly	increasingly	ADV
ihlr-18810	462	61	more	more	ADV
ihlr-18810	462	62	safe	safe	ADJ
ihlr-18810	462	63	as	as	SCONJ
ihlr-18810	462	64	new	new	ADJ
ihlr-18810	462	65	information	information	NOUN
ihlr-18810	462	66	makes	make	VERB
ihlr-18810	462	67	improvements	improvement	NOUN
ihlr-18810	462	68	in	in	ADP
ihlr-18810	462	69	product	product	NOUN
ihlr-18810	462	70	design	design	NOUN
ihlr-18810	462	71	or	or	CCONJ
ihlr-18810	462	72	labeling	labeling	NOUN
ihlr-18810	462	73	reasonable.188	reasonable.188	VERB
ihlr-18810	462	74	the	the	DET
ihlr-18810	462	75	ability	ability	NOUN
ihlr-18810	462	76	of	of	ADP
ihlr-18810	462	77	the	the	DET
ihlr-18810	462	78	tort	tort	NOUN
ihlr-18810	462	79	system	system	NOUN
ihlr-18810	462	80	to	to	PART
ihlr-18810	462	81	help	help	VERB
ihlr-18810	462	82	regulate	regulate	VERB
ihlr-18810	462	83	the	the	DET
ihlr-18810	462	84	safety	safety	NOUN
ihlr-18810	462	85	of	of	ADP
ihlr-18810	462	86	medical	medical	ADJ
ihlr-18810	462	87	devices	device	NOUN
ihlr-18810	462	88	can	can	AUX
ihlr-18810	462	89	be	be	AUX
ihlr-18810	462	90	difficult	difficult	ADJ
ihlr-18810	462	91	,	,	PUNCT
ihlr-18810	462	92	however	however	ADV
ihlr-18810	462	93	.	.	PUNCT
ihlr-18810	463	1	the	the	DET
ihlr-18810	463	2	mda	mda	PROPN
ihlr-18810	463	3	contains	contain	VERB
ihlr-18810	463	4	an	an	DET
ihlr-18810	463	5	express	express	ADJ
ihlr-18810	463	6	preemption	preemption	NOUN
ihlr-18810	463	7	clause	clause	NOUN
ihlr-18810	463	8	in	in	ADP
ihlr-18810	463	9	§	§	PROPN
ihlr-18810	463	10	360k	360k	PROPN
ihlr-18810	463	11	,	,	PUNCT
ihlr-18810	463	12	which	which	PRON
ihlr-18810	463	13	provides	provide	VERB
ihlr-18810	463	14	that	that	PRON
ihlr-18810	463	15	:	:	PUNCT
ihlr-18810	464	1	[	[	X
ihlr-18810	464	2	n1o	n1o	ADP
ihlr-18810	464	3	state	state	NOUN
ihlr-18810	464	4	or	or	CCONJ
ihlr-18810	464	5	political	political	ADJ
ihlr-18810	464	6	subdivision	subdivision	NOUN
ihlr-18810	464	7	of	of	ADP
ihlr-18810	464	8	a	a	DET
ihlr-18810	464	9	state	state	NOUN
ihlr-18810	464	10	may	may	AUX
ihlr-18810	464	11	establish	establish	VERB
ihlr-18810	464	12	or	or	CCONJ
ihlr-18810	464	13	continue	continue	VERB
ihlr-18810	464	14	in	in	ADP
ihlr-18810	464	15	effect	effect	NOUN
ihlr-18810	464	16	with	with	ADP
ihlr-18810	464	17	respect	respect	NOUN
ihlr-18810	464	18	to	to	ADP
ihlr-18810	464	19	a	a	DET
ihlr-18810	464	20	device	device	NOUN
ihlr-18810	464	21	intended	intend	VERB
ihlr-18810	464	22	for	for	ADP
ihlr-18810	464	23	human	human	ADJ
ihlr-18810	464	24	use	use	NOUN
ihlr-18810	464	25	any	any	DET
ihlr-18810	464	26	requirement-(1	requirement-(1	NOUN
ihlr-18810	464	27	)	)	PUNCT
ihlr-18810	464	28	which	which	PRON
ihlr-18810	464	29	is	be	AUX
ihlr-18810	464	30	different	different	ADJ
ihlr-18810	464	31	from	from	ADP
ihlr-18810	464	32	,	,	PUNCT
ihlr-18810	464	33	or	or	CCONJ
ihlr-18810	464	34	in	in	ADP
ihlr-18810	464	35	addition	addition	NOUN
ihlr-18810	464	36	to	to	ADP
ihlr-18810	464	37	,	,	PUNCT
ihlr-18810	464	38	any	any	DET
ihlr-18810	464	39	requirement	requirement	NOUN
ihlr-18810	464	40	applicable	applicable	ADJ
ihlr-18810	464	41	under	under	ADP
ihlr-18810	464	42	this	this	DET
ihlr-18810	464	43	chapter	chapter	NOUN
ihlr-18810	464	44	to	to	ADP
ihlr-18810	464	45	the	the	DET
ihlr-18810	464	46	device	device	NOUN
ihlr-18810	464	47	,	,	PUNCT
ihlr-18810	464	48	and	and	CCONJ
ihlr-18810	464	49	(	(	PUNCT
ihlr-18810	464	50	2	2	X
ihlr-18810	464	51	)	)	PUNCT
ihlr-18810	464	52	which	which	PRON
ihlr-18810	464	53	relates	relate	VERB
ihlr-18810	464	54	to	to	ADP
ihlr-18810	464	55	the	the	DET
ihlr-18810	464	56	safety	safety	NOUN
ihlr-18810	464	57	or	or	CCONJ
ihlr-18810	464	58	effectiveness	effectiveness	NOUN
ihlr-18810	464	59	of	of	ADP
ihlr-18810	464	60	the	the	DET
ihlr-18810	464	61	device	device	NOUN
ihlr-18810	464	62	or	or	CCONJ
ihlr-18810	464	63	to	to	ADP
ihlr-18810	464	64	any	any	DET
ihlr-18810	464	65	other	other	ADJ
ihlr-18810	464	66	matter	matter	NOUN
ihlr-18810	464	67	included	include	VERB
ihlr-18810	464	68	in	in	ADP
ihlr-18810	464	69	a	a	DET
ihlr-18810	464	70	requirement	requirement	NOUN
ihlr-18810	464	71	applicable	applicable	ADJ
ihlr-18810	464	72	to	to	ADP
ihlr-18810	464	73	the	the	DET
ihlr-18810	464	74	device	device	NOUN
ihlr-18810	464	75	under	under	ADP
ihlr-18810	464	76	this	this	DET
ihlr-18810	464	77	chapter.189	chapter.189	PROPN
ihlr-18810	464	78	section	section	NOUN
ihlr-18810	464	79	360k	360k	PROPN
ihlr-18810	464	80	raises	raise	VERB
ihlr-18810	464	81	many	many	ADJ
ihlr-18810	464	82	challenges	challenge	NOUN
ihlr-18810	464	83	to	to	PART
ihlr-18810	464	84	even	even	ADV
ihlr-18810	464	85	bringing	bring	VERB
ihlr-18810	464	86	a	a	DET
ihlr-18810	464	87	suit	suit	NOUN
ihlr-18810	464	88	that	that	PRON
ihlr-18810	464	89	alleges	allege	VERB
ihlr-18810	464	90	a	a	DET
ihlr-18810	464	91	device	device	NOUN
ihlr-18810	464	92	is	be	AUX
ihlr-18810	464	93	unsafe	unsafe	ADJ
ihlr-18810	464	94	in	in	ADP
ihlr-18810	464	95	any	any	DET
ihlr-18810	464	96	way	way	NOUN
ihlr-18810	464	97	,	,	PUNCT
ihlr-18810	464	98	causing	cause	VERB
ihlr-18810	464	99	injury	injury	NOUN
ihlr-18810	464	100	to	to	ADP
ihlr-18810	464	101	the	the	DET
ihlr-18810	464	102	patient	patient	NOUN
ihlr-18810	464	103	.	.	PUNCT
ihlr-18810	465	1	the	the	DET
ihlr-18810	465	2	collaborative	collaborative	ADJ
ihlr-18810	465	3	view	view	NOUN
ihlr-18810	465	4	of	of	ADP
ihlr-18810	465	5	the	the	DET
ihlr-18810	465	6	fda	fda	PROPN
ihlr-18810	465	7	and	and	CCONJ
ihlr-18810	465	8	the	the	DET
ihlr-18810	465	9	tort	tort	NOUN
ihlr-18810	465	10	system	system	NOUN
ihlr-18810	465	11	has	have	AUX
ihlr-18810	465	12	changed	change	VERB
ihlr-18810	465	13	in	in	ADP
ihlr-18810	465	14	recent	recent	ADJ
ihlr-18810	465	15	years	year	NOUN
ihlr-18810	465	16	as	as	SCONJ
ihlr-18810	465	17	pressure	pressure	NOUN
ihlr-18810	465	18	to	to	PART
ihlr-18810	465	19	increase	increase	VERB
ihlr-18810	465	20	innovation	innovation	NOUN
ihlr-18810	465	21	and	and	CCONJ
ihlr-18810	465	22	bring	bring	VERB
ihlr-18810	465	23	more	more	ADJ
ihlr-18810	465	24	products	product	NOUN
ihlr-18810	465	25	to	to	ADP
ihlr-18810	465	26	market	market	NOUN
ihlr-18810	465	27	has	have	AUX
ihlr-18810	465	28	grown.190	grown.190	VERB
ihlr-18810	465	29	some	some	PRON
ihlr-18810	465	30	believe	believe	VERB
ihlr-18810	465	31	that	that	SCONJ
ihlr-18810	465	32	fda	fda	PROPN
ihlr-18810	465	33	regulation	regulation	PROPN
ihlr-18810	465	34	and	and	CCONJ
ihlr-18810	465	35	review	review	NOUN
ihlr-18810	465	36	constitutes	constitute	VERB
ihlr-18810	465	37	both	both	PRON
ihlr-18810	465	38	a	a	DET
ihlr-18810	465	39	floor	floor	NOUN
ihlr-18810	465	40	and	and	CCONJ
ihlr-18810	465	41	a	a	DET
ihlr-18810	465	42	ceiling	ceiling	NOUN
ihlr-18810	465	43	;	;	PUNCT
ihlr-18810	465	44	that	that	SCONJ
ihlr-18810	465	45	the	the	DET
ihlr-18810	465	46	tort	tort	NOUN
ihlr-18810	465	47	system	system	NOUN
ihlr-18810	465	48	is	be	AUX
ihlr-18810	465	49	counterproductive	counterproductive	ADJ
ihlr-18810	465	50	to	to	ADP
ihlr-18810	465	51	ensuring	ensure	VERB
ihlr-18810	465	52	consumer	consumer	NOUN
ihlr-18810	465	53	safety	safety	NOUN
ihlr-18810	465	54	and	and	CCONJ
ihlr-18810	465	55	that	that	SCONJ
ihlr-18810	465	56	it	it	PRON
ihlr-18810	465	57	deters	deter	VERB
ihlr-18810	465	58	manufacturers	manufacturer	NOUN
ihlr-18810	465	59	from	from	ADP
ihlr-18810	465	60	developing	develop	VERB
ihlr-18810	465	61	much	much	ADV
ihlr-18810	465	62	-	-	PUNCT
ihlr-18810	465	63	needed	need	VERB
ihlr-18810	465	64	new	new	ADJ
ihlr-18810	465	65	technologies	technology	NOUN
ihlr-18810	465	66	due	due	ADP
ihlr-18810	465	67	to	to	ADP
ihlr-18810	465	68	a	a	DET
ihlr-18810	465	69	fear	fear	NOUN
ihlr-18810	465	70	of	of	ADP
ihlr-18810	465	71	tort	tort	NOUN
ihlr-18810	465	72	liability.191	liability.191	VERB
ihlr-18810	465	73	furthermore	furthermore	ADV
ihlr-18810	465	74	,	,	PUNCT
ihlr-18810	465	75	critics	critic	NOUN
ihlr-18810	465	76	have	have	AUX
ihlr-18810	465	77	also	also	ADV
ihlr-18810	465	78	argued	argue	VERB
ihlr-18810	465	79	that	that	SCONJ
ihlr-18810	465	80	lay	lie	VERB
ihlr-18810	465	81	juries	jury	NOUN
ihlr-18810	465	82	are	be	AUX
ihlr-18810	465	83	incapable	incapable	ADJ
ihlr-18810	465	84	of	of	ADP
ihlr-18810	465	85	187	187	NUM
ihlr-18810	465	86	struve	struve	NOUN
ihlr-18810	465	87	,	,	PUNCT
ihlr-18810	465	88	supra	supra	PROPN
ihlr-18810	465	89	note	note	PROPN
ihlr-18810	465	90	106	106	NUM
ihlr-18810	465	91	,	,	PUNCT
ihlr-18810	465	92	at	at	ADP
ihlr-18810	465	93	587	587	NUM
ihlr-18810	465	94	.	.	PUNCT
ihlr-18810	466	1	188	188	NUM
ihlr-18810	466	2	i	i	PROPN
ihlr-18810	466	3	d.	d.	PROPN
ihlr-18810	466	4	189	189	NUM
ihlr-18810	466	5	21	21	NUM
ihlr-18810	466	6	u.s.c	u.s.c	NOUN
ihlr-18810	466	7	.	.	PUNCT
ihlr-18810	467	1	§	§	PROPN
ihlr-18810	467	2	360k	360k	PROPN
ihlr-18810	467	3	(	(	PUNCT
ihlr-18810	467	4	2012	2012	NUM
ihlr-18810	467	5	)	)	PUNCT
ihlr-18810	467	6	.	.	PUNCT
ihlr-18810	468	1	190	190	NUM
ihlr-18810	468	2	struve	struve	PROPN
ihlr-18810	468	3	,	,	PUNCT
ihlr-18810	468	4	supra	supra	PROPN
ihlr-18810	468	5	note	note	PROPN
ihlr-18810	468	6	106	106	NUM
ihlr-18810	468	7	,	,	PUNCT
ihlr-18810	468	8	at	at	ADP
ihlr-18810	468	9	587	587	NUM
ihlr-18810	468	10	-	-	SYM
ihlr-18810	468	11	88	88	NUM
ihlr-18810	468	12	.	.	PUNCT
ihlr-18810	468	13	191	191	NUM
ihlr-18810	469	1	i	i	PRON
ihlr-18810	469	2	d.	d.	NOUN
ihlr-18810	469	3	at	at	ADP
ihlr-18810	469	4	588	588	NUM
ihlr-18810	469	5	.	.	PUNCT
ihlr-18810	470	1	vol	vol	NOUN
ihlr-18810	470	2	.	.	PUNCT
ihlr-18810	471	1	10	10	NUM
ihlr-18810	471	2	:	:	SYM
ihlr-18810	471	3	1148	1148	NUM
ihlr-18810	471	4	510(k	510(k	NUM
ihlr-18810	471	5	)	)	PUNCT
ihlr-18810	471	6	clearance	clearance	NOUN
ihlr-18810	471	7	understanding	understand	VERB
ihlr-18810	471	8	the	the	DET
ihlr-18810	471	9	scientific	scientific	ADJ
ihlr-18810	471	10	and	and	CCONJ
ihlr-18810	471	11	statistical	statistical	ADJ
ihlr-18810	471	12	evidence	evidence	NOUN
ihlr-18810	471	13	that	that	PRON
ihlr-18810	471	14	is	be	AUX
ihlr-18810	471	15	relevant	relevant	ADJ
ihlr-18810	471	16	to	to	ADP
ihlr-18810	471	17	determinations	determination	NOUN
ihlr-18810	471	18	of	of	ADP
ihlr-18810	471	19	a	a	DET
ihlr-18810	471	20	medical	medical	ADJ
ihlr-18810	471	21	product	product	NOUN
ihlr-18810	471	22	's	's	PART
ihlr-18810	471	23	safety	safety	NOUN
ihlr-18810	471	24	,	,	PUNCT
ihlr-18810	471	25	and	and	CCONJ
ihlr-18810	471	26	are	be	AUX
ihlr-18810	471	27	consequently	consequently	ADV
ihlr-18810	471	28	overly	overly	ADV
ihlr-18810	471	29	willing	willing	ADJ
ihlr-18810	471	30	to	to	PART
ihlr-18810	471	31	help	help	VERB
ihlr-18810	471	32	injured	injure	VERB
ihlr-18810	471	33	plaintiffs	plaintiff	NOUN
ihlr-18810	471	34	by	by	ADP
ihlr-18810	471	35	overlooking	overlook	VERB
ihlr-18810	471	36	the	the	DET
ihlr-18810	471	37	many	many	ADJ
ihlr-18810	471	38	other	other	ADJ
ihlr-18810	471	39	consumers	consumer	NOUN
ihlr-18810	471	40	who	who	PRON
ihlr-18810	471	41	could	could	AUX
ihlr-18810	471	42	benefit	benefit	VERB
ihlr-18810	471	43	from	from	ADP
ihlr-18810	471	44	the	the	DET
ihlr-18810	471	45	product	product	NOUN
ihlr-18810	471	46	.	.	PUNCT
ihlr-18810	472	1	192	192	NUM
ihlr-18810	472	2	these	these	DET
ihlr-18810	472	3	perspectives	perspective	NOUN
ihlr-18810	472	4	have	have	AUX
ihlr-18810	472	5	affected	affect	VERB
ihlr-18810	472	6	the	the	DET
ihlr-18810	472	7	decisions	decision	NOUN
ihlr-18810	472	8	rendered	render	VERB
ihlr-18810	472	9	by	by	ADP
ihlr-18810	472	10	courts	court	NOUN
ihlr-18810	472	11	regarding	regard	VERB
ihlr-18810	472	12	the	the	DET
ihlr-18810	472	13	preemptive	preemptive	ADJ
ihlr-18810	472	14	effect	effect	NOUN
ihlr-18810	472	15	of	of	ADP
ihlr-18810	472	16	the	the	DET
ihlr-18810	472	17	mda's.preemption	mda's.preemption	ADJ
ihlr-18810	472	18	clause	clause	NOUN
ihlr-18810	472	19	.	.	PUNCT
ihlr-18810	473	1	the	the	DET
ihlr-18810	473	2	supremacy	supremacy	NOUN
ihlr-18810	473	3	clause	clause	NOUN
ihlr-18810	473	4	of	of	ADP
ihlr-18810	473	5	the	the	DET
ihlr-18810	473	6	constitution	constitution	NOUN
ihlr-18810	473	7	gives	give	VERB
ihlr-18810	473	8	congress	congress	PROPN
ihlr-18810	473	9	the	the	DET
ihlr-18810	473	10	authority	authority	NOUN
ihlr-18810	473	11	to	to	PART
ihlr-18810	473	12	pre	pre	VERB
ihlr-18810	473	13	-	-	VERB
ihlr-18810	473	14	empt	empt	VERB
ihlr-18810	473	15	any	any	DET
ihlr-18810	473	16	state	state	NOUN
ihlr-18810	473	17	law	law	NOUN
ihlr-18810	473	18	that	that	PRON
ihlr-18810	473	19	comes	come	VERB
ihlr-18810	473	20	into	into	ADP
ihlr-18810	473	21	conflict	conflict	NOUN
ihlr-18810	473	22	with	with	ADP
ihlr-18810	473	23	the	the	DET
ihlr-18810	473	24	exercise	exercise	NOUN
ihlr-18810	473	25	of	of	ADP
ihlr-18810	473	26	federal	federal	ADJ
ihlr-18810	473	27	power	power	NOUN
ihlr-18810	473	28	.	.	PUNCT
ihlr-18810	474	1	193	193	NUM
ihlr-18810	474	2	first	first	ADV
ihlr-18810	474	3	it	it	PRON
ihlr-18810	474	4	must	must	AUX
ihlr-18810	474	5	be	be	AUX
ihlr-18810	474	6	determined	determine	VERB
ihlr-18810	474	7	whether	whether	SCONJ
ihlr-18810	474	8	congress	congress	PROPN
ihlr-18810	474	9	explicitly	explicitly	ADV
ihlr-18810	474	10	intended	intend	VERB
ihlr-18810	474	11	to	to	PART
ihlr-18810	474	12	either	either	CCONJ
ihlr-18810	474	13	preempt	preempt	VERB
ihlr-18810	474	14	the	the	DET
ihlr-18810	474	15	state	state	NOUN
ihlr-18810	474	16	law	law	NOUN
ihlr-18810	474	17	claim	claim	NOUN
ihlr-18810	474	18	,	,	PUNCT
ihlr-18810	474	19	or	or	CCONJ
ihlr-18810	474	20	leave	leave	VERB
ihlr-18810	474	21	the	the	DET
ihlr-18810	474	22	state	state	NOUN
ihlr-18810	474	23	law	law	NOUN
ihlr-18810	474	24	claim	claim	NOUN
ihlr-18810	474	25	available	available	ADJ
ihlr-18810	474	26	.	.	PUNCT
ihlr-18810	475	1	194	194	NUM
ihlr-18810	475	2	such	such	ADJ
ihlr-18810	475	3	intention	intention	NOUN
ihlr-18810	475	4	can	can	AUX
ihlr-18810	475	5	be	be	AUX
ihlr-18810	475	6	manifested	manifest	VERB
ihlr-18810	475	7	in	in	ADP
ihlr-18810	475	8	an	an	DET
ihlr-18810	475	9	express	express	ADJ
ihlr-18810	475	10	preemption	preemption	NOUN
ihlr-18810	475	11	or	or	CCONJ
ihlr-18810	475	12	savings	saving	NOUN
ihlr-18810	475	13	clause	clause	NOUN
ihlr-18810	475	14	.	.	PUNCT
ihlr-18810	476	1	9	9	NUM
ihlr-18810	476	2	5	5	NUM
ihlr-18810	476	3	as	as	SCONJ
ihlr-18810	476	4	noted	note	VERB
ihlr-18810	476	5	above	above	ADV
ihlr-18810	476	6	,	,	PUNCT
ihlr-18810	476	7	the	the	DET
ihlr-18810	476	8	mda	mda	PROPN
ihlr-18810	476	9	contains	contain	VERB
ihlr-18810	476	10	an	an	DET
ihlr-18810	476	11	express	express	ADJ
ihlr-18810	476	12	preemption	preemption	NOUN
ihlr-18810	476	13	provision	provision	NOUN
ihlr-18810	476	14	,	,	PUNCT
ihlr-18810	476	15	and	and	CCONJ
ihlr-18810	476	16	therefore	therefore	ADV
ihlr-18810	476	17	preempts	preempt	VERB
ihlr-18810	476	18	state	state	NOUN
ihlr-18810	476	19	law	law	NOUN
ihlr-18810	476	20	.	.	PUNCT
ihlr-18810	477	1	however	however	ADV
ihlr-18810	477	2	,	,	PUNCT
ihlr-18810	477	3	state	state	NOUN
ihlr-18810	477	4	law	law	NOUN
ihlr-18810	477	5	claims	claim	NOUN
ihlr-18810	477	6	against	against	ADP
ihlr-18810	477	7	product	product	NOUN
ihlr-18810	477	8	features	feature	NOUN
ihlr-18810	477	9	that	that	PRON
ihlr-18810	477	10	violate	violate	VERB
ihlr-18810	477	11	federal	federal	ADJ
ihlr-18810	477	12	law	law	NOUN
ihlr-18810	477	13	will	will	AUX
ihlr-18810	477	14	not	not	PART
ihlr-18810	477	15	be	be	AUX
ihlr-18810	477	16	preempted	preempt	VERB
ihlr-18810	477	17	because	because	SCONJ
ihlr-18810	477	18	they	they	PRON
ihlr-18810	477	19	are	be	AUX
ihlr-18810	477	20	parallel	parallel	ADJ
ihlr-18810	477	21	to	to	ADP
ihlr-18810	477	22	,	,	PUNCT
ihlr-18810	477	23	and	and	CCONJ
ihlr-18810	477	24	therefore	therefore	ADV
ihlr-18810	477	25	not	not	PART
ihlr-18810	477	26	in	in	ADP
ihlr-18810	477	27	conflict	conflict	NOUN
ihlr-18810	477	28	with	with	ADP
ihlr-18810	477	29	,	,	PUNCT
ihlr-18810	477	30	federal	federal	ADJ
ihlr-18810	477	31	law	law	NOUN
ihlr-18810	477	32	.	.	PUNCT
ihlr-18810	478	1	196	196	NUM
ihlr-18810	478	2	the	the	DET
ihlr-18810	478	3	supreme	supreme	PROPN
ihlr-18810	478	4	court	court	PROPN
ihlr-18810	478	5	has	have	AUX
ihlr-18810	478	6	decided	decide	VERB
ihlr-18810	478	7	one	one	NUM
ihlr-18810	478	8	case	case	NOUN
ihlr-18810	478	9	regarding	regard	VERB
ihlr-18810	478	10	a	a	DET
ihlr-18810	478	11	device	device	NOUN
ihlr-18810	478	12	that	that	PRON
ihlr-18810	478	13	reached	reach	VERB
ihlr-18810	478	14	the	the	DET
ihlr-18810	478	15	market	market	NOUN
ihlr-18810	478	16	through	through	ADP
ihlr-18810	478	17	the	the	DET
ihlr-18810	478	18	510(k	510(k	PROPN
ihlr-18810	478	19	)	)	PUNCT
ihlr-18810	478	20	process	process	NOUN
ihlr-18810	478	21	,	,	PUNCT
ihlr-18810	478	22	finding	find	VERB
ihlr-18810	478	23	the	the	DET
ihlr-18810	478	24	state	state	NOUN
ihlr-18810	478	25	tort	tort	NOUN
ihlr-18810	478	26	claims	claim	NOUN
ihlr-18810	478	27	were	be	AUX
ihlr-18810	478	28	not	not	PART
ihlr-18810	478	29	pre	pre	ADJ
ihlr-18810	478	30	-	-	VERB
ihlr-18810	478	31	empted	empte	VERB
ihlr-18810	478	32	.	.	PUNCT
ihlr-18810	479	1	in	in	ADP
ihlr-18810	479	2	medtronic	medtronic	PROPN
ihlr-18810	479	3	,	,	PUNCT
ihlr-18810	479	4	inc	inc	PROPN
ihlr-18810	479	5	.	.	PROPN
ihlr-18810	479	6	v.	v.	PROPN
ihlr-18810	479	7	lohr	lohr	PROPN
ihlr-18810	479	8	,	,	PUNCT
ihlr-18810	479	9	the	the	DET
ihlr-18810	479	10	court	court	NOUN
ihlr-18810	479	11	held	hold	VERB
ihlr-18810	479	12	that	that	SCONJ
ihlr-18810	479	13	the	the	DET
ihlr-18810	479	14	mda	mda	PROPN
ihlr-18810	479	15	demands	demand	VERB
ihlr-18810	479	16	three	three	NUM
ihlr-18810	479	17	things	thing	NOUN
ihlr-18810	479	18	be	be	AUX
ihlr-18810	479	19	present	present	ADJ
ihlr-18810	479	20	for	for	SCONJ
ihlr-18810	479	21	preemption	preemption	NOUN
ihlr-18810	479	22	to	to	PART
ihlr-18810	479	23	apply	apply	VERB
ihlr-18810	479	24	:	:	PUNCT
ihlr-18810	479	25	1	1	X
ihlr-18810	479	26	)	)	PUNCT
ihlr-18810	479	27	a	a	DET
ihlr-18810	479	28	specific	specific	ADJ
ihlr-18810	479	29	federal	federal	ADJ
ihlr-18810	479	30	requirement	requirement	NOUN
ihlr-18810	479	31	2	2	NUM
ihlr-18810	479	32	)	)	PUNCT
ihlr-18810	479	33	that	that	PRON
ihlr-18810	479	34	applies	apply	VERB
ihlr-18810	479	35	to	to	ADP
ihlr-18810	479	36	a	a	DET
ihlr-18810	479	37	specific	specific	ADJ
ihlr-18810	479	38	medical	medical	ADJ
ihlr-18810	479	39	device	device	NOUN
ihlr-18810	479	40	,	,	PUNCT
ihlr-18810	479	41	and	and	CCONJ
ihlr-18810	479	42	3	3	X
ihlr-18810	479	43	)	)	PUNCT
ihlr-18810	479	44	which	which	PRON
ihlr-18810	479	45	governs	govern	VERB
ihlr-18810	479	46	the	the	DET
ihlr-18810	479	47	safety	safety	NOUN
ihlr-18810	479	48	and	and	CCONJ
ihlr-18810	479	49	effectiveness	effectiveness	NOUN
ihlr-18810	479	50	of	of	ADP
ihlr-18810	479	51	the	the	DET
ihlr-18810	479	52	device.197	device.197	NOUN
ihlr-18810	479	53	therefore	therefore	ADV
ihlr-18810	479	54	,	,	PUNCT
ihlr-18810	479	55	the	the	DET
ihlr-18810	479	56	mda	mda	PROPN
ihlr-18810	479	57	does	do	AUX
ihlr-18810	479	58	not	not	PART
ihlr-18810	479	59	192	192	NUM
ihlr-18810	479	60	i	i	PRON
ihlr-18810	479	61	d.	d.	PROPN
ihlr-18810	479	62	193	193	NUM
ihlr-18810	480	1	u.s	u.s	PROPN
ihlr-18810	480	2	.	.	PROPN
ihlr-18810	480	3	const	const	PROPN
ihlr-18810	480	4	.	.	PUNCT
ihlr-18810	481	1	art	art	NOUN
ihlr-18810	481	2	.	.	PUNCT
ihlr-18810	482	1	vi	vi	PROPN
ihlr-18810	482	2	,	,	PUNCT
ihlr-18810	482	3	§	§	PROPN
ihlr-18810	482	4	1	1	NUM
ihlr-18810	482	5	,	,	PUNCT
ihlr-18810	482	6	cl	cl	NOUN
ihlr-18810	482	7	.	.	NOUN
ihlr-18810	483	1	2	2	NUM
ihlr-18810	483	2	.	.	SYM
ihlr-18810	483	3	194	194	NUM
ihlr-18810	483	4	leflar	leflar	PROPN
ihlr-18810	483	5	&	&	CCONJ
ihlr-18810	483	6	adler	adler	PROPN
ihlr-18810	483	7	,	,	PUNCT
ihlr-18810	483	8	supra	supra	PROPN
ihlr-18810	483	9	note	note	PROPN
ihlr-18810	483	10	16	16	NUM
ihlr-18810	483	11	,	,	PUNCT
ihlr-18810	483	12	at	at	ADP
ihlr-18810	483	13	710	710	NUM
ihlr-18810	483	14	.	.	PUNCT
ihlr-18810	484	1	195	195	NUM
ihlr-18810	484	2	i	i	PROPN
ihlr-18810	484	3	d.	d.	PROPN
ihlr-18810	484	4	;	;	PUNCT
ihlr-18810	484	5	cf	cf	PROPN
ihlr-18810	484	6	victor	victor	PROPN
ihlr-18810	484	7	e.	e.	PROPN
ihlr-18810	484	8	schwartz	schwartz	PROPN
ihlr-18810	484	9	&	&	CCONJ
ihlr-18810	484	10	cary	cary	PROPN
ihlr-18810	484	11	silverman	silverman	PROPN
ihlr-18810	484	12	,	,	PUNCT
ihlr-18810	484	13	preemption	preemption	NOUN
ihlr-18810	484	14	of	of	ADP
ihlr-18810	484	15	state	state	NOUN
ihlr-18810	484	16	common	common	ADJ
ihlr-18810	484	17	law	law	NOUN
ihlr-18810	484	18	by	by	ADP
ihlr-18810	484	19	federal	federal	ADJ
ihlr-18810	484	20	agency	agency	NOUN
ihlr-18810	484	21	action	action	NOUN
ihlr-18810	484	22	:	:	PUNCT
ihlr-18810	484	23	striking	strike	VERB
ihlr-18810	484	24	the	the	DET
ihlr-18810	484	25	appropriate	appropriate	ADJ
ihlr-18810	484	26	balance	balance	NOUN
ihlr-18810	484	27	that	that	PRON
ihlr-18810	484	28	protects	protect	VERB
ihlr-18810	484	29	public	public	ADJ
ihlr-18810	484	30	safety	safety	NOUN
ihlr-18810	484	31	,	,	PUNCT
ihlr-18810	484	32	84	84	NUM
ihlr-18810	484	33	tul	tul	NOUN
ihlr-18810	484	34	.	.	PUNCT
ihlr-18810	484	35	l.	l.	PROPN
ihlr-18810	484	36	rev	rev	PROPN
ihlr-18810	484	37	.	.	PROPN
ihlr-18810	484	38	1203	1203	NUM
ihlr-18810	484	39	,	,	PUNCT
ihlr-18810	484	40	1205	1205	NUM
ihlr-18810	484	41	-	-	SYM
ihlr-18810	484	42	06	06	NUM
ihlr-18810	484	43	(	(	PUNCT
ihlr-18810	484	44	2010	2010	NUM
ihlr-18810	484	45	)	)	PUNCT
ihlr-18810	484	46	(	(	PUNCT
ihlr-18810	484	47	explaining	explain	VERB
ihlr-18810	484	48	that	that	SCONJ
ihlr-18810	484	49	congress	congress	PROPN
ihlr-18810	484	50	's	's	PART
ihlr-18810	484	51	intention	intention	NOUN
ihlr-18810	484	52	to	to	PART
ihlr-18810	484	53	preempt	preempt	VERB
ihlr-18810	484	54	state	state	NOUN
ihlr-18810	484	55	law	law	NOUN
ihlr-18810	484	56	may	may	AUX
ihlr-18810	484	57	be	be	AUX
ihlr-18810	484	58	implied	imply	VERB
ihlr-18810	484	59	through	through	ADP
ihlr-18810	484	60	field	field	NOUN
ihlr-18810	484	61	preemption	preemption	NOUN
ihlr-18810	484	62	,	,	PUNCT
ihlr-18810	484	63	which	which	PRON
ihlr-18810	484	64	occurs	occur	VERB
ihlr-18810	484	65	when	when	SCONJ
ihlr-18810	484	66	congress	congress	PROPN
ihlr-18810	484	67	expresses	express	VERB
ihlr-18810	484	68	an	an	DET
ihlr-18810	484	69	intention	intention	NOUN
ihlr-18810	484	70	to	to	PART
ihlr-18810	484	71	occupy	occupy	VERB
ihlr-18810	484	72	an	an	DET
ihlr-18810	484	73	entire	entire	ADJ
ihlr-18810	484	74	regulatory	regulatory	ADJ
ihlr-18810	484	75	field	field	NOUN
ihlr-18810	484	76	and	and	CCONJ
ihlr-18810	484	77	thereby	thereby	ADV
ihlr-18810	484	78	leaves	leave	VERB
ihlr-18810	484	79	no	no	DET
ihlr-18810	484	80	room	room	NOUN
ihlr-18810	484	81	for	for	ADP
ihlr-18810	484	82	state	state	NOUN
ihlr-18810	484	83	regulation	regulation	NOUN
ihlr-18810	484	84	)	)	PUNCT
ihlr-18810	484	85	.	.	PUNCT
ihlr-18810	485	1	196	196	NUM
ihlr-18810	485	2	leflar	leflar	PROPN
ihlr-18810	485	3	&	&	CCONJ
ihlr-18810	485	4	adler	adler	PROPN
ihlr-18810	485	5	,	,	PUNCT
ihlr-18810	485	6	supra	supra	PROPN
ihlr-18810	485	7	note	note	PROPN
ihlr-18810	485	8	16	16	NUM
ihlr-18810	485	9	,	,	PUNCT
ihlr-18810	485	10	at	at	ADP
ihlr-18810	485	11	714	714	NUM
ihlr-18810	485	12	-	-	SYM
ihlr-18810	485	13	15	15	NUM
ihlr-18810	485	14	.	.	NOUN
ihlr-18810	485	15	197	197	NUM
ihlr-18810	485	16	medtronic	medtronic	PROPN
ihlr-18810	485	17	,	,	PUNCT
ihlr-18810	485	18	inc	inc	PROPN
ihlr-18810	485	19	.	.	PROPN
ihlr-18810	486	1	v.	v.	PROPN
ihlr-18810	486	2	lohr	lohr	PROPN
ihlr-18810	486	3	,	,	PUNCT
ihlr-18810	486	4	518	518	NUM
ihlr-18810	486	5	u.s	u.s	PROPN
ihlr-18810	486	6	.	.	PROPN
ihlr-18810	486	7	470	470	NUM
ihlr-18810	486	8	,	,	PUNCT
ihlr-18810	486	9	500	500	NUM
ihlr-18810	486	10	(	(	PUNCT
ihlr-18810	486	11	1996	1996	NUM
ihlr-18810	486	12	)	)	PUNCT
ihlr-18810	486	13	;	;	PUNCT
ihlr-18810	486	14	see	see	AUX
ihlr-18810	486	15	also	also	ADV
ihlr-18810	486	16	donna	donna	PROPN
ihlr-18810	486	17	b.	b.	PROPN
ihlr-18810	486	18	devaney	devaney	PROPN
ihlr-18810	486	19	&	&	CCONJ
ihlr-18810	486	20	patrick	patrick	PROPN
ihlr-18810	486	21	a.	a.	PROPN
ihlr-18810	486	22	hamiltyon	hamiltyon	PROPN
ihlr-18810	486	23	,	,	PUNCT
ihlr-18810	486	24	the	the	DET
ihlr-18810	486	25	10,000	10,000	NUM
ihlr-18810	486	26	pound	pound	NOUN
ihlr-18810	486	27	gorilla	gorilla	NOUN
ihlr-18810	486	28	:	:	PUNCT
ihlr-18810	486	29	federal	federal	ADJ
ihlr-18810	486	30	preemption	preemption	NOUN
ihlr-18810	486	31	in	in	ADP
ihlr-18810	486	32	class	class	NOUN
ihlr-18810	486	33	iiimedical	iiimedical	ADJ
ihlr-18810	486	34	device	device	NOUN
ihlr-18810	486	35	cases	case	NOUN
ihlr-18810	486	36	,	,	PUNCT
ihlr-18810	486	37	80	80	NUM
ihlr-18810	486	38	ra	ra	NOUN
ihlr-18810	486	39	b.j	b.j	PROPN
ihlr-18810	486	40	.	.	PROPN
ihlr-18810	486	41	52	52	NUM
ihlr-18810	486	42	,	,	PUNCT
ihlr-18810	486	43	54	54	NUM
ihlr-18810	486	44	(	(	PUNCT
ihlr-18810	486	45	2006	2006	NUM
ihlr-18810	486	46	)	)	PUNCT
ihlr-18810	486	47	.	.	PUNCT
ihlr-18810	487	1	2013	2013	NUM
ihlr-18810	487	2	149	149	NUM
ihlr-18810	487	3	indiana	indiana	PROPN
ihlr-18810	487	4	health	health	PROPN
ihlr-18810	487	5	law	law	PROPN
ihlr-18810	487	6	review	review	NOUN
ihlr-18810	487	7	preempt	preempt	VERB
ihlr-18810	487	8	state	state	NOUN
ihlr-18810	487	9	common	common	ADJ
ihlr-18810	487	10	law	law	NOUN
ihlr-18810	487	11	defective	defective	ADJ
ihlr-18810	487	12	design	design	NOUN
ihlr-18810	487	13	claims	claim	NOUN
ihlr-18810	487	14	for	for	ADP
ihlr-18810	487	15	devices	device	NOUN
ihlr-18810	487	16	which	which	PRON
ihlr-18810	487	17	have	have	AUX
ihlr-18810	487	18	gone	go	VERB
ihlr-18810	487	19	to	to	ADP
ihlr-18810	487	20	market	market	NOUN
ihlr-18810	487	21	through	through	ADP
ihlr-18810	487	22	510(k	510(k	NUM
ihlr-18810	487	23	)	)	PUNCT
ihlr-18810	487	24	premarket	premarket	NOUN
ihlr-18810	487	25	notification	notification	NOUN
ihlr-18810	487	26	since	since	SCONJ
ihlr-18810	487	27	allowing	allow	VERB
ihlr-18810	487	28	a	a	DET
ihlr-18810	487	29	monetary	monetary	ADJ
ihlr-18810	487	30	damages	damage	NOUN
ihlr-18810	487	31	remedy	remedy	NOUN
ihlr-18810	487	32	does	do	AUX
ihlr-18810	487	33	not	not	PART
ihlr-18810	487	34	impose	impose	VERB
ihlr-18810	487	35	additional	additional	ADJ
ihlr-18810	487	36	"	"	PUNCT
ihlr-18810	487	37	requirements	requirement	NOUN
ihlr-18810	487	38	"	"	PUNCT
ihlr-18810	487	39	on	on	ADP
ihlr-18810	487	40	the	the	DET
ihlr-18810	487	41	manufacturer	manufacturer	NOUN
ihlr-18810	487	42	,	,	PUNCT
ihlr-18810	487	43	but	but	CCONJ
ihlr-18810	487	44	rather	rather	ADV
ihlr-18810	487	45	provides	provide	VERB
ihlr-18810	487	46	the	the	DET
ihlr-18810	487	47	manufacturer	manufacturer	NOUN
ihlr-18810	487	48	with	with	ADP
ihlr-18810	487	49	another	another	DET
ihlr-18810	487	50	reason	reason	NOUN
ihlr-18810	487	51	to	to	PART
ihlr-18810	487	52	comply	comply	VERB
ihlr-18810	487	53	with	with	ADP
ihlr-18810	487	54	the	the	DET
ihlr-18810	487	55	federal	federal	ADJ
ihlr-18810	487	56	"	"	PUNCT
ihlr-18810	487	57	requirements	requirement	NOUN
ihlr-18810	487	58	,	,	PUNCT
ihlr-18810	487	59	"	"	PUNCT
ihlr-18810	487	60	namely	namely	ADV
ihlr-18810	487	61	,	,	PUNCT
ihlr-18810	487	62	that	that	SCONJ
ihlr-18810	487	63	the	the	DET
ihlr-18810	487	64	devices	device	NOUN
ihlr-18810	487	65	be	be	VERB
ihlr-18810	487	66	reasonably	reasonably	ADV
ihlr-18810	487	67	safe	safe	ADJ
ihlr-18810	487	68	and	and	CCONJ
ihlr-18810	487	69	effective	effective	ADJ
ihlr-18810	487	70	.	.	PUNCT
ihlr-18810	488	1	198	198	NUM
ihlr-18810	488	2	additionally	additionally	ADV
ihlr-18810	488	3	,	,	PUNCT
ihlr-18810	488	4	the	the	DET
ihlr-18810	488	5	court	court	NOUN
ihlr-18810	488	6	found	find	VERB
ihlr-18810	488	7	the	the	DET
ihlr-18810	488	8	manufacturing	manufacturing	NOUN
ihlr-18810	488	9	and	and	CCONJ
ihlr-18810	488	10	labeling	labeling	NOUN
ihlr-18810	488	11	claims	claim	NOUN
ihlr-18810	488	12	,	,	PUNCT
ihlr-18810	488	13	in	in	ADP
ihlr-18810	488	14	this	this	DET
ihlr-18810	488	15	instance	instance	NOUN
ihlr-18810	488	16	,	,	PUNCT
ihlr-18810	488	17	were	be	AUX
ihlr-18810	488	18	not	not	PART
ihlr-18810	488	19	preempted.199	preempted.199	NOUN
ihlr-18810	488	20	since	since	SCONJ
ihlr-18810	488	21	the	the	DET
ihlr-18810	488	22	state	state	NOUN
ihlr-18810	488	23	law	law	NOUN
ihlr-18810	488	24	labeling	labeling	NOUN
ihlr-18810	488	25	and	and	CCONJ
ihlr-18810	488	26	manufacturing	manufacturing	NOUN
ihlr-18810	488	27	requirements	requirement	NOUN
ihlr-18810	488	28	apply	apply	VERB
ihlr-18810	488	29	to	to	ADP
ihlr-18810	488	30	many	many	ADJ
ihlr-18810	488	31	different	different	ADJ
ihlr-18810	488	32	devices	device	NOUN
ihlr-18810	488	33	,	,	PUNCT
ihlr-18810	488	34	they	they	PRON
ihlr-18810	488	35	are	be	AUX
ihlr-18810	488	36	laws	law	NOUN
ihlr-18810	488	37	of	of	ADP
ihlr-18810	488	38	general	general	ADJ
ihlr-18810	488	39	applicability	applicability	NOUN
ihlr-18810	488	40	.	.	PUNCT
ihlr-18810	489	1	2	2	NUM
ihlr-18810	489	2	00	00	NUM
ihlr-18810	489	3	without	without	ADP
ihlr-18810	489	4	specific	specific	ADJ
ihlr-18810	489	5	federal	federal	ADJ
ihlr-18810	489	6	requirements	requirement	NOUN
ihlr-18810	489	7	,	,	PUNCT
ihlr-18810	489	8	there	there	PRON
ihlr-18810	489	9	can	can	AUX
ihlr-18810	489	10	not	not	PART
ihlr-18810	489	11	be	be	AUX
ihlr-18810	489	12	preemption	preemption	NOUN
ihlr-18810	489	13	of	of	ADP
ihlr-18810	489	14	the	the	DET
ihlr-18810	489	15	state	state	NOUN
ihlr-18810	489	16	law	law	NOUN
ihlr-18810	489	17	claims	claim	VERB
ihlr-18810	489	18	because	because	SCONJ
ihlr-18810	489	19	there	there	PRON
ihlr-18810	489	20	is	be	VERB
ihlr-18810	489	21	no	no	DET
ihlr-18810	489	22	conflict	conflict	NOUN
ihlr-18810	489	23	between	between	ADP
ihlr-18810	489	24	federal	federal	ADJ
ihlr-18810	489	25	and	and	CCONJ
ihlr-18810	489	26	state	state	NOUN
ihlr-18810	489	27	requirements	requirement	NOUN
ihlr-18810	489	28	.	.	PUNCT
ihlr-18810	490	1	20	20	NUM
ihlr-18810	490	2	1	1	NUM
ihlr-18810	490	3	in	in	ADP
ihlr-18810	490	4	light	light	NOUN
ihlr-18810	490	5	of	of	ADP
ihlr-18810	490	6	the	the	DET
ihlr-18810	490	7	court	court	NOUN
ihlr-18810	490	8	's	's	PART
ihlr-18810	490	9	finding	find	VERB
ihlr-18810	490	10	lohr	lohr	NOUN
ihlr-18810	490	11	,	,	PUNCT
ihlr-18810	490	12	the	the	DET
ihlr-18810	490	13	tort	tort	NOUN
ihlr-18810	490	14	system	system	NOUN
ihlr-18810	490	15	remains	remain	VERB
ihlr-18810	490	16	available	available	ADJ
ihlr-18810	490	17	to	to	PART
ihlr-18810	490	18	help	help	VERB
ihlr-18810	490	19	regulate	regulate	VERB
ihlr-18810	490	20	the	the	DET
ihlr-18810	490	21	safety	safety	NOUN
ihlr-18810	490	22	of	of	ADP
ihlr-18810	490	23	510(k	510(k	PROPN
ihlr-18810	490	24	)	)	PUNCT
ihlr-18810	490	25	devices	device	NOUN
ihlr-18810	490	26	by	by	ADP
ihlr-18810	490	27	offering	offer	VERB
ihlr-18810	490	28	financial	financial	ADJ
ihlr-18810	490	29	awards	award	NOUN
ihlr-18810	490	30	for	for	ADP
ihlr-18810	490	31	injured	injure	VERB
ihlr-18810	490	32	plaintiffs	plaintiff	NOUN
ihlr-18810	490	33	as	as	ADV
ihlr-18810	490	34	well	well	ADV
ihlr-18810	490	35	as	as	ADP
ihlr-18810	490	36	financial	financial	ADJ
ihlr-18810	490	37	incentives	incentive	NOUN
ihlr-18810	490	38	for	for	ADP
ihlr-18810	490	39	manufactures	manufacture	NOUN
ihlr-18810	490	40	to	to	ADP
ihlr-18810	490	41	pro	pro	ADJ
ihlr-18810	490	42	-	-	ADJ
ihlr-18810	490	43	duce	duce	ADJ
ihlr-18810	490	44	safe	safe	ADJ
ihlr-18810	490	45	devices	device	NOUN
ihlr-18810	490	46	.	.	PUNCT
ihlr-18810	491	1	this	this	DET
ihlr-18810	491	2	shift	shift	NOUN
ihlr-18810	491	3	of	of	ADP
ihlr-18810	491	4	the	the	DET
ihlr-18810	491	5	source	source	NOUN
ihlr-18810	491	6	of	of	ADP
ihlr-18810	491	7	pressure	pressure	NOUN
ihlr-18810	491	8	on	on	ADP
ihlr-18810	491	9	the	the	DET
ihlr-18810	491	10	medical	medical	ADJ
ihlr-18810	491	11	device	device	NOUN
ihlr-18810	491	12	industry	industry	NOUN
ihlr-18810	491	13	,	,	PUNCT
ihlr-18810	491	14	from	from	ADP
ihlr-18810	491	15	the	the	DET
ihlr-18810	491	16	fda	fda	PROPN
ihlr-18810	491	17	to	to	ADP
ihlr-18810	491	18	the	the	DET
ihlr-18810	491	19	tort	tort	NOUN
ihlr-18810	491	20	system	system	NOUN
ihlr-18810	491	21	,	,	PUNCT
ihlr-18810	491	22	to	to	PART
ihlr-18810	491	23	ensure	ensure	VERB
ihlr-18810	491	24	the	the	DET
ihlr-18810	491	25	safety	safety	NOUN
ihlr-18810	491	26	of	of	ADP
ihlr-18810	491	27	medical	medical	ADJ
ihlr-18810	491	28	devices	device	NOUN
ihlr-18810	491	29	makes	make	VERB
ihlr-18810	491	30	sense	sense	NOUN
ihlr-18810	491	31	in	in	ADP
ihlr-18810	491	32	these	these	DET
ihlr-18810	491	33	circumstances	circumstance	NOUN
ihlr-18810	491	34	,	,	PUNCT
ihlr-18810	491	35	since	since	SCONJ
ihlr-18810	491	36	the	the	DET
ihlr-18810	491	37	fda	fda	PROPN
ihlr-18810	491	38	plays	play	VERB
ihlr-18810	491	39	a	a	DET
ihlr-18810	491	40	much	much	ADV
ihlr-18810	491	41	smaller	small	ADJ
ihlr-18810	491	42	role	role	NOUN
ihlr-18810	491	43	in	in	ADP
ihlr-18810	491	44	the	the	DET
ihlr-18810	491	45	regulation	regulation	NOUN
ihlr-18810	491	46	of	of	ADP
ihlr-18810	491	47	510(k	510(k	PROPN
ihlr-18810	491	48	)	)	PUNCT
ihlr-18810	491	49	cleared	clear	VERB
ihlr-18810	491	50	devices	device	NOUN
ihlr-18810	491	51	.	.	PUNCT
ihlr-18810	492	1	this	this	PRON
ihlr-18810	492	2	is	be	AUX
ihlr-18810	492	3	very	very	ADV
ihlr-18810	492	4	different	different	ADJ
ihlr-18810	492	5	from	from	ADP
ihlr-18810	492	6	the	the	DET
ihlr-18810	492	7	impact	impact	NOUN
ihlr-18810	492	8	the	the	DET
ihlr-18810	492	9	tort	tort	NOUN
ihlr-18810	492	10	system	system	NOUN
ihlr-18810	492	11	has	have	VERB
ihlr-18810	492	12	on	on	ADP
ihlr-18810	492	13	devices	device	NOUN
ihlr-18810	492	14	198	198	NUM
ihlr-18810	492	15	lohr	lohr	NOUN
ihlr-18810	492	16	,	,	PUNCT
ihlr-18810	493	1	518	518	NUM
ihlr-18810	493	2	u.s	u.s	PROPN
ihlr-18810	493	3	.	.	PROPN
ihlr-18810	493	4	at	at	ADP
ihlr-18810	493	5	495	495	NUM
ihlr-18810	493	6	.	.	PUNCT
ihlr-18810	494	1	199	199	NUM
ihlr-18810	495	1	i	i	NOUN
ihlr-18810	495	2	d.	d.	PROPN
ihlr-18810	495	3	at	at	ADP
ihlr-18810	495	4	498	498	NUM
ihlr-18810	495	5	.	.	PUNCT
ihlr-18810	496	1	200	200	NUM
ihlr-18810	496	2	i	i	PROPN
ihlr-18810	496	3	d.	d.	PROPN
ihlr-18810	496	4	201	201	NUM
ihlr-18810	496	5	see	see	VERB
ihlr-18810	496	6	generally	generally	ADV
ihlr-18810	496	7	21	21	NUM
ihlr-18810	496	8	c.f.r	c.f.r	NOUN
ihlr-18810	496	9	.	.	PUNCT
ihlr-18810	497	1	§	§	PROPN
ihlr-18810	497	2	801.430	801.430	NUM
ihlr-18810	497	3	(	(	PUNCT
ihlr-18810	497	4	2012	2012	NUM
ihlr-18810	497	5	)	)	PUNCT
ihlr-18810	497	6	(	(	PUNCT
ihlr-18810	497	7	stating	state	VERB
ihlr-18810	497	8	that	that	SCONJ
ihlr-18810	497	9	tampons	tampon	NOUN
ihlr-18810	497	10	must	must	AUX
ihlr-18810	497	11	include	include	VERB
ihlr-18810	497	12	labels	label	NOUN
ihlr-18810	497	13	describing	describe	VERB
ihlr-18810	497	14	the	the	DET
ihlr-18810	497	15	danger	danger	NOUN
ihlr-18810	497	16	of	of	ADP
ihlr-18810	497	17	toxic	toxic	ADJ
ihlr-18810	497	18	shock	shock	NOUN
ihlr-18810	497	19	syndrome	syndrome	NOUN
ihlr-18810	497	20	)	)	PUNCT
ihlr-18810	497	21	;	;	PUNCT
ihlr-18810	497	22	nat'l	nat'l	PROPN
ihlr-18810	497	23	bank	bank	PROPN
ihlr-18810	497	24	of	of	ADP
ihlr-18810	497	25	commerce	commerce	PROPN
ihlr-18810	497	26	v.	v.	ADP
ihlr-18810	497	27	kimberly	kimberly	PROPN
ihlr-18810	497	28	-	-	PUNCT
ihlr-18810	497	29	clark	clark	PROPN
ihlr-18810	497	30	corp	corp	PROPN
ihlr-18810	497	31	.	.	PROPN
ihlr-18810	497	32	,	,	PUNCT
ihlr-18810	497	33	38	38	NUM
ihlr-18810	497	34	f.3d	f.3d	NUM
ihlr-18810	497	35	988	988	NUM
ihlr-18810	497	36	,	,	PUNCT
ihlr-18810	497	37	990	990	NUM
ihlr-18810	497	38	(	(	PUNCT
ihlr-18810	497	39	8th	8th	ADJ
ihlr-18810	497	40	cir	cir	NOUN
ihlr-18810	497	41	.	.	PROPN
ihlr-18810	497	42	1994	1994	NUM
ihlr-18810	497	43	)	)	PUNCT
ihlr-18810	497	44	(	(	PUNCT
ihlr-18810	497	45	holding	hold	VERB
ihlr-18810	497	46	the	the	DET
ihlr-18810	497	47	fda	fda	PROPN
ihlr-18810	497	48	's	's	PART
ihlr-18810	497	49	requirement	requirement	NOUN
ihlr-18810	497	50	that	that	SCONJ
ihlr-18810	497	51	tampons	tampon	NOUN
ihlr-18810	497	52	include	include	VERB
ihlr-18810	497	53	labeling	labeling	NOUN
ihlr-18810	497	54	that	that	PRON
ihlr-18810	497	55	warns	warn	VERB
ihlr-18810	497	56	customers	customer	NOUN
ihlr-18810	497	57	of	of	ADP
ihlr-18810	497	58	the	the	DET
ihlr-18810	497	59	dangers	danger	NOUN
ihlr-18810	497	60	of	of	ADP
ihlr-18810	497	61	toxic	toxic	ADJ
ihlr-18810	497	62	shock	shock	NOUN
ihlr-18810	497	63	syndrome	syndrome	NOUN
ihlr-18810	497	64	preempts	preempt	VERB
ihlr-18810	497	65	state	state	NOUN
ihlr-18810	497	66	law	law	NOUN
ihlr-18810	497	67	)	)	PUNCT
ihlr-18810	497	68	;	;	PUNCT
ihlr-18810	497	69	natural	natural	ADJ
ihlr-18810	497	70	rubber	rubber	NOUN
ihlr-18810	497	71	-	-	PUNCT
ihlr-18810	497	72	containing	contain	VERB
ihlr-18810	497	73	medical	medical	ADJ
ihlr-18810	497	74	devices	device	NOUN
ihlr-18810	497	75	;	;	PUNCT
ihlr-18810	497	76	user	user	NOUN
ihlr-18810	497	77	labeling	labeling	NOUN
ihlr-18810	497	78	,	,	PUNCT
ihlr-18810	497	79	62	62	NUM
ihlr-18810	497	80	fed	feed	VERB
ihlr-18810	497	81	.	.	PUNCT
ihlr-18810	498	1	reg	reg	PROPN
ihlr-18810	498	2	.	.	PUNCT
ihlr-18810	499	1	51021	51021	NUM
ihlr-18810	499	2	-	-	SYM
ihlr-18810	499	3	01	01	NUM
ihlr-18810	499	4	(	(	PUNCT
ihlr-18810	499	5	effective	effective	ADJ
ihlr-18810	499	6	sept	sept	PROPN
ihlr-18810	499	7	.	.	PROPN
ihlr-18810	499	8	30	30	NUM
ihlr-18810	499	9	,	,	PUNCT
ihlr-18810	499	10	1997	1997	NUM
ihlr-18810	499	11	)	)	PUNCT
ihlr-18810	499	12	(	(	PUNCT
ihlr-18810	499	13	to	to	PART
ihlr-18810	499	14	be	be	AUX
ihlr-18810	499	15	codified	codify	VERB
ihlr-18810	499	16	at	at	ADP
ihlr-18810	499	17	21	21	NUM
ihlr-18810	499	18	c.f.r	c.f.r	NOUN
ihlr-18810	499	19	.	.	PUNCT
ihlr-18810	500	1	§	§	PROPN
ihlr-18810	500	2	801.437	801.437	NUM
ihlr-18810	500	3	)	)	PUNCT
ihlr-18810	500	4	(	(	PUNCT
ihlr-18810	500	5	establishing	establish	VERB
ihlr-18810	500	6	the	the	DET
ihlr-18810	500	7	final	final	ADJ
ihlr-18810	500	8	rule	rule	NOUN
ihlr-18810	500	9	of	of	ADP
ihlr-18810	500	10	the	the	DET
ihlr-18810	500	11	fda	fda	PROPN
ihlr-18810	500	12	allergy	allergy	NOUN
ihlr-18810	500	13	warning	warn	VERB
ihlr-18810	500	14	requirements	requirement	NOUN
ihlr-18810	500	15	for	for	ADP
ihlr-18810	500	16	latex	latex	NOUN
ihlr-18810	500	17	gloves	glove	NOUN
ihlr-18810	500	18	)	)	PUNCT
ihlr-18810	500	19	;	;	PUNCT
ihlr-18810	500	20	fed	fed	PROPN
ihlr-18810	500	21	.	.	PROPN
ihlr-18810	500	22	drug	drug	PROPN
ihlr-18810	500	23	.	.	PUNCT
ihlr-18810	501	1	admin	admin	PROPN
ihlr-18810	501	2	.	.	PROPN
ihlr-18810	501	3	,	,	PUNCT
ihlr-18810	501	4	ode	ode	PROPN
ihlr-18810	501	5	doc	doc	PROPN
ihlr-18810	501	6	.	.	PUNCT
ihlr-18810	502	1	no	no	INTJ
ihlr-18810	502	2	.	.	NOUN
ihlr-18810	502	3	1725	1725	NUM
ihlr-18810	502	4	,	,	PUNCT
ihlr-18810	502	5	guidance	guidance	NOUN
ihlr-18810	502	6	for	for	ADP
ihlr-18810	502	7	industry	industry	NOUN
ihlr-18810	502	8	and	and	CCONJ
ihlr-18810	502	9	food	food	NOUN
ihlr-18810	502	10	and	and	CCONJ
ihlr-18810	502	11	drug	drug	PROPN
ihlr-18810	502	12	administration	administration	NOUN
ihlr-18810	502	13	staff	staff	NOUN
ihlr-18810	502	14	contact	contact	NOUN
ihlr-18810	502	15	lens	lens	NOUN
ihlr-18810	502	16	care	care	NOUN
ihlr-18810	502	17	products	product	NOUN
ihlr-18810	502	18	labeling	labeling	NOUN
ihlr-18810	502	19	(	(	PUNCT
ihlr-18810	502	20	aug	aug	PROPN
ihlr-18810	502	21	.	.	PROPN
ihlr-18810	502	22	15	15	NUM
ihlr-18810	502	23	,	,	PUNCT
ihlr-18810	502	24	2010	2010	NUM
ihlr-18810	502	25	)	)	PUNCT
ihlr-18810	502	26	,	,	PUNCT
ihlr-18810	502	27	available	available	ADJ
ihlr-18810	502	28	at	at	ADP
ihlr-18810	502	29	http://www.fda.gov/downloads/medicaldevices/	http://www.fda.gov/downloads/medicaldevices/	PROPN
ihlr-18810	502	30	deviceregulationandguidance	deviceregulationandguidance	PROPN
ihlr-18810	502	31	/	/	SYM
ihlr-18810	502	32	guidancedocuments	guidancedocuments	PROPN
ihlr-18810	502	33	/	/	SYM
ihlr-18810	502	34	ucm223665.pdf	ucm223665.pdf	PROPN
ihlr-18810	502	35	(	(	PUNCT
ihlr-18810	502	36	discussing	discuss	VERB
ihlr-18810	502	37	labeling	labeling	NOUN
ihlr-18810	502	38	and	and	CCONJ
ihlr-18810	502	39	package	package	NOUN
ihlr-18810	502	40	insert	insert	NOUN
ihlr-18810	502	41	requirements	requirement	NOUN
ihlr-18810	502	42	for	for	ADP
ihlr-18810	502	43	contact	contact	NOUN
ihlr-18810	502	44	lens	lens	NOUN
ihlr-18810	502	45	solutions	solution	NOUN
ihlr-18810	502	46	)	)	PUNCT
ihlr-18810	502	47	.	.	PUNCT
ihlr-18810	503	1	vol	vol	NOUN
ihlr-18810	503	2	.	.	PUNCT
ihlr-18810	504	1	10:1150	10:1150	NUM
ihlr-18810	505	1	510(k	510(k	X
ihlr-18810	505	2	)	)	PUNCT
ihlr-18810	505	3	clearance	clearance	NOUN
ihlr-18810	505	4	which	which	PRON
ihlr-18810	505	5	have	have	AUX
ihlr-18810	505	6	received	receive	VERB
ihlr-18810	505	7	pma	pma	NOUN
ihlr-18810	505	8	.	.	PUNCT
ihlr-18810	506	1	the	the	DET
ihlr-18810	506	2	supreme	supreme	PROPN
ihlr-18810	506	3	court	court	PROPN
ihlr-18810	506	4	held	hold	VERB
ihlr-18810	506	5	that	that	SCONJ
ihlr-18810	506	6	mda	mda	PROPN
ihlr-18810	506	7	preemption	preemption	NOUN
ihlr-18810	506	8	exists	exist	VERB
ihlr-18810	506	9	over	over	ADP
ihlr-18810	506	10	claims	claim	NOUN
ihlr-18810	506	11	that	that	SCONJ
ihlr-18810	506	12	a	a	DET
ihlr-18810	506	13	device	device	NOUN
ihlr-18810	506	14	approved	approve	VERB
ihlr-18810	506	15	through	through	ADP
ihlr-18810	506	16	the	the	DET
ihlr-18810	506	17	pma	pma	NOUN
ihlr-18810	506	18	process	process	NOUN
ihlr-18810	506	19	violates	violate	VERB
ihlr-18810	506	20	state	state	NOUN
ihlr-18810	506	21	law	law	NOUN
ihlr-18810	506	22	.	.	PUNCT
ihlr-18810	507	1	in	in	ADP
ihlr-18810	507	2	riegel	riegel	PROPN
ihlr-18810	507	3	v.	v.	PROPN
ihlr-18810	507	4	medtronic	medtronic	PROPN
ihlr-18810	507	5	,	,	PUNCT
ihlr-18810	507	6	inc	inc	PROPN
ihlr-18810	507	7	.	.	PROPN
ihlr-18810	507	8	,	,	PUNCT
ihlr-18810	507	9	the	the	DET
ihlr-18810	507	10	court	court	NOUN
ihlr-18810	507	11	found	find	VERB
ihlr-18810	507	12	that	that	SCONJ
ihlr-18810	507	13	the	the	DET
ihlr-18810	507	14	pma	pma	NOUN
ihlr-18810	507	15	process	process	NOUN
ihlr-18810	507	16	imposes	impose	VERB
ihlr-18810	507	17	"	"	PUNCT
ihlr-18810	507	18	requirements	requirement	NOUN
ihlr-18810	507	19	"	"	PUNCT
ihlr-18810	507	20	upon	upon	SCONJ
ihlr-18810	507	21	devices	device	NOUN
ihlr-18810	507	22	;	;	PUNCT
ihlr-18810	507	23	requirements	requirement	NOUN
ihlr-18810	507	24	that	that	PRON
ihlr-18810	507	25	are	be	AUX
ihlr-18810	507	26	specific	specific	ADJ
ihlr-18810	507	27	to	to	ADP
ihlr-18810	507	28	each	each	DET
ihlr-18810	507	29	individual	individual	ADJ
ihlr-18810	507	30	device	device	NOUN
ihlr-18810	507	31	granted	grant	VERB
ihlr-18810	507	32	approval	approval	NOUN
ihlr-18810	507	33	.	.	PUNCT
ihlr-18810	508	1	202	202	NUM
ihlr-18810	508	2	consequently	consequently	ADV
ihlr-18810	508	3	,	,	PUNCT
ihlr-18810	508	4	the	the	DET
ihlr-18810	508	5	pma	pma	NOUN
ihlr-18810	508	6	process	process	NOUN
ihlr-18810	508	7	is	be	AUX
ihlr-18810	508	8	a	a	DET
ihlr-18810	508	9	federal	federal	ADJ
ihlr-18810	508	10	safety	safety	NOUN
ihlr-18810	508	11	review	review	NOUN
ihlr-18810	508	12	of	of	ADP
ihlr-18810	508	13	the	the	DET
ihlr-18810	508	14	device.203	device.203	ADJ
ihlr-18810	508	15	state	state	NOUN
ihlr-18810	508	16	law	law	NOUN
ihlr-18810	508	17	claims	claim	NOUN
ihlr-18810	508	18	would	would	AUX
ihlr-18810	508	19	therefore	therefore	ADV
ihlr-18810	508	20	be	be	AUX
ihlr-18810	508	21	preempted	preempt	VERB
ihlr-18810	508	22	if	if	SCONJ
ihlr-18810	508	23	they	they	PRON
ihlr-18810	508	24	imposed	impose	VERB
ihlr-18810	508	25	either	either	CCONJ
ihlr-18810	508	26	additional	additional	ADJ
ihlr-18810	508	27	requirements	requirement	NOUN
ihlr-18810	508	28	,	,	PUNCT
ihlr-18810	508	29	or	or	CCONJ
ihlr-18810	508	30	requirements	requirement	NOUN
ihlr-18810	508	31	that	that	PRON
ihlr-18810	508	32	came	come	VERB
ihlr-18810	508	33	into	into	ADP
ihlr-18810	508	34	conflict	conflict	NOUN
ihlr-18810	508	35	with	with	ADP
ihlr-18810	508	36	those	those	PRON
ihlr-18810	508	37	imposed	impose	VERB
ihlr-18810	508	38	by	by	ADP
ihlr-18810	508	39	the	the	DET
ihlr-18810	508	40	fda	fda	PROPN
ihlr-18810	508	41	.	.	PUNCT
ihlr-18810	509	1	however	however	ADV
ihlr-18810	509	2	,	,	PUNCT
ihlr-18810	509	3	the	the	DET
ihlr-18810	509	4	court	court	NOUN
ihlr-18810	509	5	found	find	VERB
ihlr-18810	509	6	that	that	SCONJ
ihlr-18810	509	7	the	the	DET
ihlr-18810	509	8	mda	mda	PROPN
ihlr-18810	509	9	's	's	PART
ihlr-18810	509	10	preemption	preemption	NOUN
ihlr-18810	509	11	provision	provision	NOUN
ihlr-18810	509	12	does	do	AUX
ihlr-18810	509	13	not	not	PART
ihlr-18810	509	14	prevent	prevent	VERB
ihlr-18810	509	15	states	state	NOUN
ihlr-18810	509	16	from	from	ADP
ihlr-18810	509	17	providing	provide	VERB
ihlr-18810	509	18	a	a	DET
ihlr-18810	509	19	damages	damage	NOUN
ihlr-18810	509	20	remedy	remedy	NOUN
ihlr-18810	509	21	for	for	ADP
ihlr-18810	509	22	parallel	parallel	ADJ
ihlr-18810	509	23	claims	claim	NOUN
ihlr-18810	509	24	(	(	PUNCT
ihlr-18810	509	25	claims	claim	NOUN
ihlr-18810	509	26	premised	premise	VERB
ihlr-18810	509	27	on	on	ADP
ihlr-18810	509	28	a	a	DET
ihlr-18810	509	29	violation	violation	NOUN
ihlr-18810	509	30	of	of	ADP
ihlr-18810	509	31	fda	fda	PROPN
ihlr-18810	509	32	regulations	regulation	NOUN
ihlr-18810	509	33	)	)	PUNCT
ihlr-18810	509	34	since	since	SCONJ
ihlr-18810	509	35	such	such	ADJ
ihlr-18810	509	36	claims	claim	NOUN
ihlr-18810	509	37	do	do	AUX
ihlr-18810	509	38	not	not	PART
ihlr-18810	509	39	add	add	VERB
ihlr-18810	509	40	to	to	ADP
ihlr-18810	509	41	federal	federal	ADJ
ihlr-18810	509	42	requirements	requirement	NOUN
ihlr-18810	509	43	.	.	PUNCT
ihlr-18810	510	1	204	204	NUM
ihlr-18810	510	2	many	many	ADJ
ihlr-18810	510	3	people	people	NOUN
ihlr-18810	510	4	,	,	PUNCT
ihlr-18810	510	5	including	include	VERB
ihlr-18810	510	6	both	both	DET
ihlr-18810	510	7	patients	patient	NOUN
ihlr-18810	510	8	and	and	CCONJ
ihlr-18810	510	9	doctors	doctor	NOUN
ihlr-18810	510	10	,	,	PUNCT
ihlr-18810	510	11	were	be	AUX
ihlr-18810	510	12	unhappy	unhappy	ADJ
ihlr-18810	510	13	with	with	ADP
ihlr-18810	510	14	the	the	DET
ihlr-18810	510	15	supreme	supreme	PROPN
ihlr-18810	510	16	court	court	PROPN
ihlr-18810	510	17	's	's	PART
ihlr-18810	510	18	decision	decision	NOUN
ihlr-18810	510	19	in	in	ADP
ihlr-18810	510	20	riegel	riegel	NOUN
ihlr-18810	510	21	granting	grant	VERB
ihlr-18810	510	22	broad	broad	ADJ
ihlr-18810	510	23	preemption	preemption	NOUN
ihlr-18810	510	24	of	of	ADP
ihlr-18810	510	25	state	state	NOUN
ihlr-18810	510	26	law	law	NOUN
ihlr-18810	510	27	design	design	NOUN
ihlr-18810	510	28	and	and	CCONJ
ihlr-18810	510	29	warning	warning	NOUN
ihlr-18810	510	30	claims	claim	NOUN
ihlr-18810	510	31	,	,	PUNCT
ihlr-18810	510	32	and	and	CCONJ
ihlr-18810	510	33	feared	fear	VERB
ihlr-18810	510	34	it	it	PRON
ihlr-18810	510	35	would	would	AUX
ihlr-18810	510	36	have	have	VERB
ihlr-18810	510	37	an	an	DET
ihlr-18810	510	38	adverse	adverse	ADJ
ihlr-18810	510	39	impact	impact	NOUN
ihlr-18810	510	40	of	of	ADP
ihlr-18810	510	41	the	the	DET
ihlr-18810	510	42	safety	safety	NOUN
ihlr-18810	510	43	of	of	ADP
ihlr-18810	510	44	medical	medical	ADJ
ihlr-18810	510	45	devices	device	NOUN
ihlr-18810	510	46	.	.	PUNCT
ihlr-18810	511	1	205	205	NUM
ihlr-18810	511	2	on	on	ADP
ihlr-18810	511	3	march	march	PROPN
ihlr-18810	511	4	5	5	NUM
ihlr-18810	511	5	,	,	PUNCT
ihlr-18810	511	6	2009	2009	NUM
ihlr-18810	512	1	,	,	PUNCT
ihlr-18810	512	2	the	the	DET
ihlr-18810	512	3	medical	medical	ADJ
ihlr-18810	512	4	device	device	NOUN
ihlr-18810	512	5	safety	safety	NOUN
ihlr-18810	512	6	act	act	NOUN
ihlr-18810	512	7	of	of	ADP
ihlr-18810	512	8	2009	2009	NUM
ihlr-18810	512	9	was	be	AUX
ihlr-18810	512	10	introduced	introduce	VERB
ihlr-18810	512	11	into	into	ADP
ihlr-18810	512	12	congress	congress	PROPN
ihlr-18810	512	13	.	.	PUNCT
ihlr-18810	513	1	206	206	NUM
ihlr-18810	513	2	this	this	DET
ihlr-18810	513	3	act	act	NOUN
ihlr-18810	513	4	would	would	AUX
ihlr-18810	513	5	have	have	AUX
ihlr-18810	513	6	added	add	VERB
ihlr-18810	513	7	language	language	NOUN
ihlr-18810	513	8	to	to	ADP
ihlr-18810	513	9	the	the	DET
ihlr-18810	513	10	mda	mda	PROPN
ihlr-18810	513	11	that	that	PRON
ihlr-18810	513	12	would	would	AUX
ihlr-18810	513	13	restore	restore	VERB
ihlr-18810	513	14	a	a	DET
ihlr-18810	513	15	plaintiffs	plaintiff	NOUN
ihlr-18810	513	16	ability	ability	NOUN
ihlr-18810	513	17	to	to	PART
ihlr-18810	513	18	bring	bring	VERB
ihlr-18810	513	19	state	state	NOUN
ihlr-18810	513	20	law	law	NOUN
ihlr-18810	513	21	claims	claim	NOUN
ihlr-18810	513	22	for	for	ADP
ihlr-18810	513	23	injuries	injury	NOUN
ihlr-18810	513	24	caused	cause	VERB
ihlr-18810	513	25	by	by	ADP
ihlr-18810	513	26	defective	defective	ADJ
ihlr-18810	513	27	medical	medical	ADJ
ihlr-18810	513	28	devices	device	NOUN
ihlr-18810	513	29	,	,	PUNCT
ihlr-18810	513	30	207	207	NUM
ihlr-18810	513	31	and	and	CCONJ
ihlr-18810	513	32	have	have	VERB
ihlr-18810	513	33	the	the	DET
ihlr-18810	513	34	effect	effect	NOUN
ihlr-18810	513	35	of	of	ADP
ihlr-18810	513	36	placing	place	VERB
ihlr-18810	513	37	medical	medical	ADJ
ihlr-18810	513	38	device	device	NOUN
ihlr-18810	513	39	claims	claim	NOUN
ihlr-18810	513	40	on	on	ADP
ihlr-18810	513	41	the	the	DET
ihlr-18810	513	42	same	same	ADJ
ihlr-18810	513	43	level	level	NOUN
ihlr-18810	513	44	as	as	ADP
ihlr-18810	513	45	202	202	NUM
ihlr-18810	513	46	riegel	riegel	NOUN
ihlr-18810	513	47	v.	v.	PROPN
ihlr-18810	513	48	medtronic	medtronic	PROPN
ihlr-18810	513	49	,	,	PUNCT
ihlr-18810	513	50	inc	inc	PROPN
ihlr-18810	513	51	.	.	PROPN
ihlr-18810	513	52	,	,	PUNCT
ihlr-18810	513	53	552	552	NUM
ihlr-18810	513	54	u.s	u.s	PROPN
ihlr-18810	513	55	.	.	PROPN
ihlr-18810	513	56	312	312	NUM
ihlr-18810	513	57	,	,	PUNCT
ihlr-18810	513	58	322	322	NUM
ihlr-18810	513	59	-	-	SYM
ihlr-18810	513	60	23	23	NUM
ihlr-18810	513	61	(	(	PUNCT
ihlr-18810	513	62	2008	2008	NUM
ihlr-18810	513	63	)	)	PUNCT
ihlr-18810	513	64	;	;	PUNCT
ihlr-18810	513	65	see	see	VERB
ihlr-18810	513	66	also	also	ADV
ihlr-18810	513	67	medtronic	medtronic	ADJ
ihlr-18810	513	68	,	,	PUNCT
ihlr-18810	513	69	inc	inc	PROPN
ihlr-18810	513	70	.	.	PROPN
ihlr-18810	514	1	v.	v.	PROPN
ihlr-18810	514	2	lohr	lohr	PROPN
ihlr-18810	514	3	,	,	PUNCT
ihlr-18810	514	4	518	518	NUM
ihlr-18810	514	5	u.s	u.s	PROPN
ihlr-18810	514	6	.	.	PROPN
ihlr-18810	514	7	470	470	NUM
ihlr-18810	514	8	,	,	PUNCT
ihlr-18810	514	9	488	488	NUM
ihlr-18810	514	10	-	-	SYM
ihlr-18810	514	11	89	89	NUM
ihlr-18810	514	12	(	(	PUNCT
ihlr-18810	514	13	1996	1996	NUM
ihlr-18810	514	14	)	)	PUNCT
ihlr-18810	514	15	(	(	PUNCT
ihlr-18810	514	16	interpreting	interpret	VERB
ihlr-18810	514	17	the	the	DET
ihlr-18810	514	18	scope	scope	NOUN
ihlr-18810	514	19	of	of	ADP
ihlr-18810	514	20	the	the	DET
ihlr-18810	514	21	word	word	NOUN
ihlr-18810	514	22	requirement	requirement	NOUN
ihlr-18810	514	23	)	)	PUNCT
ihlr-18810	514	24	.	.	PUNCT
ihlr-18810	515	1	203	203	NUM
ihlr-18810	515	2	riegel	riegel	NOUN
ihlr-18810	515	3	,	,	PUNCT
ihlr-18810	515	4	552	552	NUM
ihlr-18810	515	5	u.s	u.s	PROPN
ihlr-18810	515	6	.	.	PROPN
ihlr-18810	515	7	at	at	ADP
ihlr-18810	515	8	323	323	NUM
ihlr-18810	515	9	(	(	PUNCT
ihlr-18810	515	10	cf	cf	NOUN
ihlr-18810	515	11	lohr	lohr	NOUN
ihlr-18810	515	12	,	,	PUNCT
ihlr-18810	515	13	518	518	NUM
ihlr-18810	515	14	u.s	u.s	PROPN
ihlr-18810	515	15	.	.	PROPN
ihlr-18810	515	16	at	at	ADP
ihlr-18810	515	17	488	488	NUM
ihlr-18810	515	18	)	)	PUNCT
ihlr-18810	515	19	.	.	PUNCT
ihlr-18810	516	1	204	204	NUM
ihlr-18810	516	2	riegel	riegel	NOUN
ihlr-18810	516	3	,	,	PUNCT
ihlr-18810	516	4	552	552	NUM
ihlr-18810	516	5	u.s	u.s	PROPN
ihlr-18810	516	6	.	.	PROPN
ihlr-18810	516	7	at	at	ADP
ihlr-18810	516	8	330	330	NUM
ihlr-18810	516	9	.	.	SYM
ihlr-18810	516	10	205	205	NUM
ihlr-18810	516	11	gregory	gregory	PROPN
ihlr-18810	516	12	d.	d.	PROPN
ihlr-18810	516	13	curfman	curfman	PROPN
ihlr-18810	516	14	,	,	PUNCT
ihlr-18810	516	15	stephen	stephen	PROPN
ihlr-18810	516	16	morrissey	morrissey	PROPN
ihlr-18810	516	17	&	&	CCONJ
ihlr-18810	516	18	jeffrey	jeffrey	PROPN
ihlr-18810	516	19	m.	m.	PROPN
ihlr-18810	516	20	drazen	drazen	PROPN
ihlr-18810	516	21	,	,	PUNCT
ihlr-18810	516	22	the	the	DET
ihlr-18810	516	23	medical	medical	ADJ
ihlr-18810	516	24	device	device	NOUN
ihlr-18810	516	25	safety	safety	NOUN
ihlr-18810	516	26	act	act	NOUN
ihlr-18810	516	27	of	of	ADP
ihlr-18810	516	28	2009	2009	NUM
ihlr-18810	516	29	,	,	PUNCT
ihlr-18810	516	30	360	360	NUM
ihlr-18810	516	31	new	new	ADJ
ihlr-18810	516	32	eng	eng	PROPN
ihlr-18810	516	33	.	.	PUNCT
ihlr-18810	517	1	j.	j.	PROPN
ihlr-18810	517	2	med	med	PROPN
ihlr-18810	517	3	.	.	PROPN
ihlr-18810	518	1	1550	1550	NUM
ihlr-18810	518	2	,	,	PUNCT
ihlr-18810	518	3	1550	1550	NUM
ihlr-18810	518	4	-	-	SYM
ihlr-18810	518	5	51	51	NUM
ihlr-18810	518	6	(	(	PUNCT
ihlr-18810	518	7	2009	2009	NUM
ihlr-18810	518	8	)	)	PUNCT
ihlr-18810	518	9	(	(	PUNCT
ihlr-18810	518	10	stating	state	VERB
ihlr-18810	518	11	that	that	SCONJ
ihlr-18810	518	12	"	"	PUNCT
ihlr-18810	518	13	[	[	X
ihlr-18810	518	14	ulntil	ulntil	NOUN
ihlr-18810	518	15	[	[	X
ihlr-18810	518	16	the	the	DET
ihlr-18810	518	17	riegel	riegel	NOUN
ihlr-18810	518	18	ruling	ruling	NOUN
ihlr-18810	518	19	,	,	PUNCT
ihlr-18810	518	20	]	]	PUNCT
ihlr-18810	518	21	the	the	DET
ihlr-18810	518	22	possibility	possibility	NOUN
ihlr-18810	518	23	of	of	ADP
ihlr-18810	518	24	litigation	litigation	NOUN
ihlr-18810	518	25	for	for	ADP
ihlr-18810	518	26	'	'	PUNCT
ihlr-18810	518	27	failure	failure	NOUN
ihlr-18810	518	28	to	to	PART
ihlr-18810	518	29	warn	warn	VERB
ihlr-18810	518	30	'	'	PUNCT
ihlr-18810	518	31	or	or	CCONJ
ihlr-18810	518	32	design	design	NOUN
ihlr-18810	518	33	defect	defect	NOUN
ihlr-18810	518	34	served	serve	VERB
ihlr-18810	518	35	as	as	ADP
ihlr-18810	518	36	a	a	DET
ihlr-18810	518	37	strong	strong	ADJ
ihlr-18810	518	38	inducement	inducement	NOUN
ihlr-18810	518	39	for	for	SCONJ
ihlr-18810	518	40	device	device	NOUN
ihlr-18810	518	41	companies	company	NOUN
ihlr-18810	518	42	to	to	PART
ihlr-18810	518	43	be	be	AUX
ihlr-18810	518	44	vigilant	vigilant	ADJ
ihlr-18810	518	45	about	about	ADP
ihlr-18810	518	46	the	the	DET
ihlr-18810	518	47	safety	safety	NOUN
ihlr-18810	518	48	of	of	ADP
ihlr-18810	518	49	their	their	PRON
ihlr-18810	518	50	products	product	NOUN
ihlr-18810	518	51	"	"	PUNCT
ihlr-18810	518	52	)	)	PUNCT
ihlr-18810	518	53	.	.	PUNCT
ihlr-18810	519	1	206	206	NUM
ihlr-18810	519	2	medical	medical	ADJ
ihlr-18810	519	3	device	device	NOUN
ihlr-18810	519	4	safety	safety	NOUN
ihlr-18810	519	5	act	act	NOUN
ihlr-18810	519	6	of	of	ADP
ihlr-18810	519	7	2009	2009	NUM
ihlr-18810	519	8	,	,	PUNCT
ihlr-18810	519	9	h.r	h.r	PROPN
ihlr-18810	519	10	.	.	PROPN
ihlr-18810	519	11	1346	1346	NUM
ihlr-18810	519	12	,	,	PUNCT
ihlr-18810	519	13	111th	111th	ADJ
ihlr-18810	519	14	cong	cong	NOUN
ihlr-18810	519	15	.	.	PUNCT
ihlr-18810	520	1	(	(	PUNCT
ihlr-18810	520	2	2009	2009	NUM
ihlr-18810	520	3	)	)	PUNCT
ihlr-18810	521	1	[	[	X
ihlr-18810	521	2	hereinafter	hereinafter	NOUN
ihlr-18810	521	3	medical	medical	ADJ
ihlr-18810	521	4	device	device	NOUN
ihlr-18810	521	5	safety	safety	PROPN
ihlr-18810	521	6	act	act	PROPN
ihlr-18810	521	7	]	]	PUNCT
ihlr-18810	521	8	,	,	PUNCT
ihlr-18810	521	9	available	available	ADJ
ihlr-18810	521	10	at	at	ADP
ihlr-18810	521	11	http://www	http://www	PROPN
ihlr-18810	521	12	.	.	PUNCT
ihlr-18810	521	13	govtrack.us/congress/bill.xpd?bill=h1	govtrack.us/congress/bill.xpd?bill=h1	PROPN
ihlr-18810	521	14	11	11	NUM
ihlr-18810	521	15	-	-	SYM
ihlr-18810	521	16	1346	1346	NUM
ihlr-18810	521	17	.	.	PUNCT
ihlr-18810	522	1	207	207	NUM
ihlr-18810	523	1	i	i	PRON
ihlr-18810	523	2	d.	d.	PROPN
ihlr-18810	523	3	2013	2013	NUM
ihlr-18810	523	4	151	151	NUM
ihlr-18810	523	5	indiana	indiana	PROPN
ihlr-18810	523	6	health	health	PROPN
ihlr-18810	523	7	law	law	PROPN
ihlr-18810	523	8	review	review	VERB
ihlr-18810	523	9	pharmaceutical	pharmaceutical	NOUN
ihlr-18810	523	10	claims	claim	NOUN
ihlr-18810	523	11	208	208	NUM
ihlr-18810	523	12	with	with	ADP
ihlr-18810	523	13	regard	regard	NOUN
ihlr-18810	523	14	to	to	ADP
ihlr-18810	523	15	preemption	preemption	NOUN
ihlr-18810	523	16	.	.	PUNCT
ihlr-18810	524	1	209	209	NUM
ihlr-18810	524	2	although	although	SCONJ
ihlr-18810	524	3	this	this	DET
ihlr-18810	524	4	act	act	NOUN
ihlr-18810	524	5	received	receive	VERB
ihlr-18810	524	6	a	a	DET
ihlr-18810	524	7	lot	lot	NOUN
ihlr-18810	524	8	of	of	ADP
ihlr-18810	524	9	support	support	NOUN
ihlr-18810	524	10	,	,	PUNCT
ihlr-18810	524	11	210	210	NUM
ihlr-18810	524	12	by	by	ADP
ihlr-18810	524	13	the	the	DET
ihlr-18810	524	14	end	end	NOUN
ihlr-18810	524	15	of	of	ADP
ihlr-18810	524	16	the	the	DET
ihlr-18810	524	17	111th	111th	ADJ
ihlr-18810	524	18	session	session	NOUN
ihlr-18810	524	19	of	of	ADP
ihlr-18810	524	20	congress	congress	PROPN
ihlr-18810	524	21	it	it	PRON
ihlr-18810	524	22	had	have	AUX
ihlr-18810	524	23	not	not	PART
ihlr-18810	524	24	been	be	AUX
ihlr-18810	524	25	passed	pass	VERB
ihlr-18810	524	26	and	and	CCONJ
ihlr-18810	524	27	therefore	therefore	ADV
ihlr-18810	524	28	was	be	AUX
ihlr-18810	524	29	declared	declare	VERB
ihlr-18810	524	30	dead.211	dead.211	NOUN
ihlr-18810	524	31	it	it	PRON
ihlr-18810	524	32	has	have	AUX
ihlr-18810	524	33	not	not	PART
ihlr-18810	524	34	been	be	AUX
ihlr-18810	524	35	reintroduced	reintroduce	VERB
ihlr-18810	524	36	.	.	PUNCT
ihlr-18810	525	1	2	2	NUM
ihlr-18810	525	2	12	12	NUM
ihlr-18810	525	3	iii	iii	NOUN
ihlr-18810	525	4	.	.	PUNCT
ihlr-18810	526	1	proposals	proposal	NOUN
ihlr-18810	526	2	to	to	PART
ihlr-18810	526	3	fix	fix	VERB
ihlr-18810	526	4	the	the	DET
ihlr-18810	526	5	flaws	flaw	NOUN
ihlr-18810	526	6	in	in	ADP
ihlr-18810	526	7	the	the	DET
ihlr-18810	526	8	system	system	NOUN
ihlr-18810	526	9	a.	a.	PROPN
ihlr-18810	526	10	institute	institute	PROPN
ihlr-18810	526	11	ofmedicine	ofmedicine	ADJ
ihlr-18810	526	12	.	.	PUNCT
ihlr-18810	527	1	:	:	PUNCT
ihlr-18810	527	2	a	a	DET
ihlr-18810	527	3	new	new	ADJ
ihlr-18810	527	4	regulatory	regulatory	ADJ
ihlr-18810	527	5	system	system	NOUN
ihlr-18810	527	6	for	for	ADP
ihlr-18810	527	7	510(k	510(k	PROPN
ihlr-18810	527	8	)	)	PUNCT
ihlr-18810	527	9	devices	device	NOUN
ihlr-18810	527	10	in	in	ADP
ihlr-18810	527	11	light	light	NOUN
ihlr-18810	527	12	of	of	ADP
ihlr-18810	527	13	all	all	PRON
ihlr-18810	527	14	of	of	ADP
ihlr-18810	527	15	the	the	DET
ihlr-18810	527	16	issues	issue	NOUN
ihlr-18810	527	17	already	already	ADV
ihlr-18810	527	18	discussed	discuss	VERB
ihlr-18810	527	19	surrounding	surround	VERB
ihlr-18810	527	20	the	the	DET
ihlr-18810	527	21	510(k	510(k	PROPN
ihlr-18810	527	22	)	)	PUNCT
ihlr-18810	527	23	process	process	NOUN
ihlr-18810	527	24	and	and	CCONJ
ihlr-18810	527	25	the	the	DET
ihlr-18810	527	26	lack	lack	NOUN
ihlr-18810	527	27	of	of	ADP
ihlr-18810	527	28	pre	pre	ADJ
ihlr-18810	527	29	-	-	ADJ
ihlr-18810	527	30	market	market	ADJ
ihlr-18810	527	31	evaluation	evaluation	NOUN
ihlr-18810	527	32	of	of	ADP
ihlr-18810	527	33	these	these	DET
ihlr-18810	527	34	devices	device	NOUN
ihlr-18810	527	35	for	for	ADP
ihlr-18810	527	36	safety	safety	NOUN
ihlr-18810	527	37	,	,	PUNCT
ihlr-18810	527	38	proposals	proposal	NOUN
ihlr-18810	527	39	have	have	AUX
ihlr-18810	527	40	been	be	AUX
ihlr-18810	527	41	made	make	VERB
ihlr-18810	527	42	to	to	PART
ihlr-18810	527	43	change	change	VERB
ihlr-18810	527	44	the	the	DET
ihlr-18810	527	45	regulatory	regulatory	ADJ
ihlr-18810	527	46	process	process	NOUN
ihlr-18810	527	47	and	and	CCONJ
ihlr-18810	527	48	ensure	ensure	VERB
ihlr-18810	527	49	device	device	NOUN
ihlr-18810	527	50	safety	safety	NOUN
ihlr-18810	527	51	and	and	CCONJ
ihlr-18810	527	52	effectiveness	effectiveness	NOUN
ihlr-18810	527	53	are	be	AUX
ihlr-18810	527	54	evaluated	evaluate	VERB
ihlr-18810	527	55	on	on	ADP
ihlr-18810	527	56	the	the	DET
ihlr-18810	527	57	front	front	ADJ
ihlr-18810	527	58	end	end	NOUN
ihlr-18810	527	59	,	,	PUNCT
ihlr-18810	527	60	much	much	ADV
ihlr-18810	527	61	as	as	SCONJ
ihlr-18810	527	62	is	be	AUX
ihlr-18810	527	63	the	the	DET
ihlr-18810	527	64	case	case	NOUN
ihlr-18810	527	65	for	for	ADP
ihlr-18810	527	66	devices	device	NOUN
ihlr-18810	527	67	entering	enter	VERB
ihlr-18810	527	68	the	the	DET
ihlr-18810	527	69	market	market	NOUN
ihlr-18810	527	70	through	through	ADP
ihlr-18810	527	71	the	the	DET
ihlr-18810	527	72	pma	pma	NOUN
ihlr-18810	527	73	process	process	NOUN
ihlr-18810	527	74	.	.	PUNCT
ihlr-18810	528	1	such	such	ADJ
ihlr-18810	528	2	changes	change	NOUN
ihlr-18810	528	3	will	will	AUX
ihlr-18810	528	4	leave	leave	VERB
ihlr-18810	528	5	the	the	DET
ihlr-18810	528	6	fda	fda	PROPN
ihlr-18810	528	7	alone	alone	ADV
ihlr-18810	528	8	to	to	PART
ihlr-18810	528	9	regulate	regulate	VERB
ihlr-18810	528	10	devices	device	NOUN
ihlr-18810	528	11	,	,	PUNCT
ihlr-18810	528	12	however	however	ADV
ihlr-18810	528	13	,	,	PUNCT
ihlr-18810	528	14	due	due	ADP
ihlr-18810	528	15	to	to	ADP
ihlr-18810	528	16	the	the	DET
ihlr-18810	528	17	preemptive	preemptive	ADJ
ihlr-18810	528	18	effect	effect	NOUN
ihlr-18810	528	19	these	these	DET
ihlr-18810	528	20	determinations	determination	NOUN
ihlr-18810	528	21	would	would	AUX
ihlr-18810	528	22	have	have	VERB
ihlr-18810	528	23	on	on	ADP
ihlr-18810	528	24	state	state	NOUN
ihlr-18810	528	25	tort	tort	NOUN
ihlr-18810	528	26	claims	claim	NOUN
ihlr-18810	528	27	raised	raise	VERB
ihlr-18810	528	28	by	by	ADP
ihlr-18810	528	29	injured	injure	VERB
ihlr-18810	528	30	plaintiffs	plaintiff	NOUN
ihlr-18810	528	31	.	.	PUNCT
ihlr-18810	529	1	to	to	PART
ihlr-18810	529	2	address	address	VERB
ihlr-18810	529	3	many	many	ADJ
ihlr-18810	529	4	of	of	ADP
ihlr-18810	529	5	the	the	DET
ihlr-18810	529	6	safety	safety	NOUN
ihlr-18810	529	7	concerns	concern	NOUN
ihlr-18810	529	8	surrounding	surround	VERB
ihlr-18810	529	9	the	the	DET
ihlr-18810	529	10	510(k	510(k	PROPN
ihlr-18810	529	11	)	)	PUNCT
ihlr-18810	529	12	clearance	clearance	NOUN
ihlr-18810	529	13	process	process	NOUN
ihlr-18810	529	14	,	,	PUNCT
ihlr-18810	529	15	the	the	DET
ihlr-18810	529	16	fda	fda	PROPN
ihlr-18810	529	17	asked	ask	VERB
ihlr-18810	529	18	the	the	DET
ihlr-18810	529	19	iom	iom	PROPN
ihlr-18810	529	20	to	to	PART
ihlr-18810	529	21	review	review	VERB
ihlr-18810	529	22	the	the	DET
ihlr-18810	529	23	process	process	NOUN
ihlr-18810	529	24	and	and	CCONJ
ihlr-18810	529	25	determine	determine	VERB
ihlr-18810	529	26	whether	whether	SCONJ
ihlr-18810	529	27	the	the	DET
ihlr-18810	529	28	process	process	NOUN
ihlr-18810	529	29	adequately	adequately	ADV
ihlr-18810	529	30	protects	protect	VERB
ihlr-18810	529	31	patients	patient	NOUN
ihlr-18810	529	32	and	and	CCONJ
ihlr-18810	529	33	,	,	PUNCT
ihlr-18810	529	34	if	if	SCONJ
ihlr-18810	529	35	not	not	PART
ihlr-18810	529	36	,	,	PUNCT
ihlr-18810	529	37	what	what	DET
ihlr-18810	529	38	legislative	legislative	ADJ
ihlr-18810	529	39	,	,	PUNCT
ihlr-18810	529	40	regulatory	regulatory	ADJ
ihlr-18810	529	41	,	,	PUNCT
ihlr-18810	529	42	or	or	CCONJ
ihlr-18810	529	43	administrative	administrative	ADJ
ihlr-18810	529	44	changes	change	NOUN
ihlr-18810	529	45	would	would	AUX
ihlr-18810	529	46	optimally	optimally	ADV
ihlr-18810	529	47	achieve	achieve	VERB
ihlr-18810	529	48	the	the	DET
ihlr-18810	529	49	goals	goal	NOUN
ihlr-18810	529	50	of	of	ADP
ihlr-18810	529	51	the	the	DET
ihlr-18810	529	52	510(k	510(k	PROPN
ihlr-18810	529	53	)	)	PUNCT
ihlr-18810	529	54	process	process	NOUN
ihlr-18810	529	55	.	.	PUNCT
ihlr-18810	530	1	213	213	NUM
ihlr-18810	530	2	the	the	DET
ihlr-18810	530	3	committee	committee	NOUN
ihlr-18810	530	4	tasked	task	VERB
ihlr-18810	530	5	with	with	ADP
ihlr-18810	530	6	this	this	DET
ihlr-18810	530	7	evaluation	evaluation	NOUN
ihlr-18810	530	8	is	be	AUX
ihlr-18810	530	9	the	the	DET
ihlr-18810	530	10	committee	committee	NOUN
ihlr-18810	530	11	on	on	ADP
ihlr-18810	530	12	public	public	ADJ
ihlr-18810	530	13	health	health	NOUN
ihlr-18810	530	14	effectiveness	effectiveness	NOUN
ihlr-18810	530	15	of	of	ADP
ihlr-18810	530	16	the	the	DET
ihlr-18810	530	17	fda	fda	PROPN
ihlr-18810	530	18	510(k	510(k	PROPN
ihlr-18810	530	19	)	)	PUNCT
ihlr-18810	530	20	clearance	clearance	NOUN
ihlr-18810	530	21	208	208	NUM
ihlr-18810	530	22	in	in	ADP
ihlr-18810	530	23	wyeth	wyeth	PROPN
ihlr-18810	530	24	v.	v.	PROPN
ihlr-18810	530	25	levine	levine	PROPN
ihlr-18810	530	26	,	,	PUNCT
ihlr-18810	530	27	the	the	DET
ihlr-18810	530	28	supreme	supreme	PROPN
ihlr-18810	530	29	court	court	PROPN
ihlr-18810	530	30	reinforced	reinforce	VERB
ihlr-18810	530	31	the	the	DET
ihlr-18810	530	32	fda	fda	PROPN
ihlr-18810	530	33	's	's	PART
ihlr-18810	530	34	position	position	NOUN
ihlr-18810	530	35	that	that	SCONJ
ihlr-18810	530	36	state	state	NOUN
ihlr-18810	530	37	law	law	NOUN
ihlr-18810	530	38	offers	offer	VERB
ihlr-18810	530	39	an	an	DET
ihlr-18810	530	40	important	important	ADJ
ihlr-18810	530	41	level	level	NOUN
ihlr-18810	530	42	of	of	ADP
ihlr-18810	530	43	consumer	consumer	NOUN
ihlr-18810	530	44	protection	protection	NOUN
ihlr-18810	530	45	that	that	PRON
ihlr-18810	530	46	complements	complement	VERB
ihlr-18810	530	47	the	the	DET
ihlr-18810	530	48	effectiveness	effectiveness	NOUN
ihlr-18810	530	49	of	of	ADP
ihlr-18810	530	50	the	the	DET
ihlr-18810	530	51	federal	federal	ADJ
ihlr-18810	530	52	laws	law	NOUN
ihlr-18810	530	53	governing	govern	VERB
ihlr-18810	530	54	pharmaceuticals	pharmaceutical	NOUN
ihlr-18810	530	55	.	.	PUNCT
ihlr-18810	531	1	wyeth	wyeth	PROPN
ihlr-18810	531	2	v.	v.	PROPN
ihlr-18810	531	3	levine	levine	PROPN
ihlr-18810	531	4	,	,	PUNCT
ihlr-18810	531	5	129	129	NUM
ihlr-18810	531	6	s.	s.	PROPN
ihlr-18810	531	7	ct	ct	PROPN
ihlr-18810	531	8	.	.	PROPN
ihlr-18810	531	9	1187	1187	NUM
ihlr-18810	531	10	,	,	PUNCT
ihlr-18810	531	11	1202	1202	NUM
ihlr-18810	531	12	(	(	PUNCT
ihlr-18810	531	13	2009	2009	NUM
ihlr-18810	531	14	)	)	PUNCT
ihlr-18810	531	15	.	.	PUNCT
ihlr-18810	532	1	209	209	NUM
ihlr-18810	532	2	support	support	VERB
ihlr-18810	532	3	the	the	DET
ihlr-18810	532	4	medical	medical	ADJ
ihlr-18810	532	5	device	device	NOUN
ihlr-18810	532	6	safety	safety	NOUN
ihlr-18810	532	7	act	act	PROPN
ihlr-18810	532	8	!	!	PUNCT
ihlr-18810	532	9	,	,	PUNCT
ihlr-18810	532	10	mdsa	mdsa	NOUN
ihlr-18810	532	11	coalition	coalition	NOUN
ihlr-18810	532	12	(	(	PUNCT
ihlr-18810	532	13	nov	nov	PROPN
ihlr-18810	532	14	.	.	PROPN
ihlr-18810	532	15	11	11	NUM
ihlr-18810	532	16	,	,	PUNCT
ihlr-18810	532	17	2010	2010	NUM
ihlr-18810	532	18	)	)	PUNCT
ihlr-18810	532	19	,	,	PUNCT
ihlr-18810	532	20	http://passmdsa.blogspot.com/2010/09/blog-post.html	http://passmdsa.blogspot.com/2010/09/blog-post.html	X
ihlr-18810	532	21	(	(	PUNCT
ihlr-18810	532	22	"	"	PUNCT
ihlr-18810	532	23	the	the	DET
ihlr-18810	532	24	bill	bill	NOUN
ihlr-18810	532	25	will	will	AUX
ihlr-18810	532	26	also	also	ADV
ihlr-18810	532	27	reconcile	reconcile	VERB
ihlr-18810	532	28	the	the	DET
ihlr-18810	532	29	legal	legal	ADJ
ihlr-18810	532	30	regime	regime	NOUN
ihlr-18810	532	31	used	use	VERB
ihlr-18810	532	32	for	for	ADP
ihlr-18810	532	33	device	device	NOUN
ihlr-18810	532	34	manufacturers	manufacturer	NOUN
ihlr-18810	532	35	with	with	ADP
ihlr-18810	532	36	the	the	DET
ihlr-18810	532	37	one	one	NOUN
ihlr-18810	532	38	used	use	VERB
ihlr-18810	532	39	for	for	ADP
ihlr-18810	532	40	drug	drug	NOUN
ihlr-18810	532	41	manufacturers	manufacturer	NOUN
ihlr-18810	532	42	,	,	PUNCT
ihlr-18810	532	43	in	in	ADP
ihlr-18810	532	44	light	light	NOUN
ihlr-18810	532	45	of	of	ADP
ihlr-18810	532	46	the	the	DET
ihlr-18810	532	47	supreme	supreme	PROPN
ihlr-18810	532	48	court	court	PROPN
ihlr-18810	532	49	's	's	PART
ihlr-18810	532	50	2009	2009	NUM
ihlr-18810	532	51	decision	decision	NOUN
ihlr-18810	532	52	in	in	ADP
ihlr-18810	532	53	wyeth	wyeth	PROPN
ihlr-18810	532	54	v.	v.	PROPN
ihlr-18810	532	55	levine	levine	PROPN
ihlr-18810	532	56	.	.	PUNCT
ihlr-18810	532	57	"	"	PUNCT
ihlr-18810	532	58	)	)	PUNCT
ihlr-18810	532	59	.	.	PUNCT
ihlr-18810	533	1	210	210	NUM
ihlr-18810	533	2	see	see	VERB
ihlr-18810	533	3	i	i	PRON
ihlr-18810	533	4	d.	d.	PROPN
ihlr-18810	533	5	211	211	NUM
ihlr-18810	533	6	medical	medical	ADJ
ihlr-18810	533	7	device	device	NOUN
ihlr-18810	533	8	safety	safety	NOUN
ihlr-18810	533	9	act	act	PROPN
ihlr-18810	533	10	,	,	PUNCT
ihlr-18810	533	11	supra	supra	PROPN
ihlr-18810	533	12	note	note	NOUN
ihlr-18810	533	13	206	206	NUM
ihlr-18810	533	14	.	.	PUNCT
ihlr-18810	534	1	212	212	NUM
ihlr-18810	535	1	i	i	PRON
ihlr-18810	535	2	d.	d.	PROPN
ihlr-18810	535	3	213	213	NUM
ihlr-18810	535	4	iom	iom	PROPN
ihlr-18810	535	5	report	report	NOUN
ihlr-18810	535	6	,	,	PUNCT
ihlr-18810	535	7	supra	supra	PROPN
ihlr-18810	535	8	note	note	NOUN
ihlr-18810	535	9	6	6	NUM
ihlr-18810	535	10	,	,	PUNCT
ihlr-18810	535	11	at	at	ADP
ihlr-18810	535	12	4	4	NUM
ihlr-18810	535	13	.	.	NOUN
ihlr-18810	535	14	152	152	NUM
ihlr-18810	535	15	vol	vol	NOUN
ihlr-18810	535	16	.	.	PUNCT
ihlr-18810	536	1	10:1	10:1	NUM
ihlr-18810	536	2	510(k	510(k	X
ihlr-18810	536	3	)	)	PUNCT
ihlr-18810	536	4	clearance	clearance	NOUN
ihlr-18810	536	5	process	process	NOUN
ihlr-18810	536	6	(	(	PUNCT
ihlr-18810	536	7	cphe).214	cphe).214	ADV
ihlr-18810	536	8	the	the	DET
ihlr-18810	536	9	cphe	cphe	NOUN
ihlr-18810	536	10	made	make	VERB
ihlr-18810	536	11	a	a	DET
ihlr-18810	536	12	number	number	NOUN
ihlr-18810	536	13	of	of	ADP
ihlr-18810	536	14	recommendations	recommendation	NOUN
ihlr-18810	536	15	in	in	ADP
ihlr-18810	536	16	their	their	PRON
ihlr-18810	536	17	report	report	NOUN
ihlr-18810	536	18	to	to	PART
ihlr-18810	536	19	improve	improve	VERB
ihlr-18810	536	20	the	the	DET
ihlr-18810	536	21	510(k	510(k	PROPN
ihlr-18810	536	22	)	)	PUNCT
ihlr-18810	536	23	clearance	clearance	NOUN
ihlr-18810	536	24	process	process	NOUN
ihlr-18810	536	25	and	and	CCONJ
ihlr-18810	536	26	,	,	PUNCT
ihlr-18810	536	27	consequently	consequently	ADV
ihlr-18810	536	28	,	,	PUNCT
ihlr-18810	536	29	improve	improve	VERB
ihlr-18810	536	30	the	the	DET
ihlr-18810	536	31	fda	fda	PROPN
ihlr-18810	536	32	's	's	PART
ihlr-18810	536	33	regulation	regulation	NOUN
ihlr-18810	536	34	of	of	ADP
ihlr-18810	536	35	these	these	DET
ihlr-18810	536	36	devices	device	NOUN
ihlr-18810	536	37	.	.	PUNCT
ihlr-18810	537	1	the	the	DET
ihlr-18810	537	2	first	first	ADJ
ihlr-18810	537	3	conclusion	conclusion	NOUN
ihlr-18810	537	4	drawn	draw	VERB
ihlr-18810	537	5	by	by	ADP
ihlr-18810	537	6	the	the	DET
ihlr-18810	537	7	cphe	cphe	NOUN
ihlr-18810	537	8	was	be	AUX
ihlr-18810	537	9	that	that	SCONJ
ihlr-18810	537	10	the	the	DET
ihlr-18810	537	11	510(k	510(k	PROPN
ihlr-18810	537	12	)	)	PUNCT
ihlr-18810	537	13	process	process	NOUN
ihlr-18810	537	14	is	be	AUX
ihlr-18810	537	15	not	not	PART
ihlr-18810	537	16	intended	intend	VERB
ihlr-18810	537	17	to	to	PART
ihlr-18810	537	18	evaluate	evaluate	VERB
ihlr-18810	537	19	the	the	DET
ihlr-18810	537	20	safety	safety	NOUN
ihlr-18810	537	21	or	or	CCONJ
ihlr-18810	537	22	efficacy	efficacy	NOUN
ihlr-18810	537	23	of	of	ADP
ihlr-18810	537	24	devices	device	NOUN
ihlr-18810	537	25	,	,	PUNCT
ihlr-18810	537	26	and	and	CCONJ
ihlr-18810	537	27	can	can	AUX
ihlr-18810	537	28	not	not	PART
ihlr-18810	537	29	be	be	AUX
ihlr-18810	537	30	transformed	transform	VERB
ihlr-18810	537	31	into	into	ADP
ihlr-18810	537	32	such	such	DET
ihlr-18810	537	33	an	an	DET
ihlr-18810	537	34	evaluation	evaluation	NOUN
ihlr-18810	537	35	as	as	ADV
ihlr-18810	537	36	long	long	ADV
ihlr-18810	537	37	as	as	SCONJ
ihlr-18810	537	38	the	the	DET
ihlr-18810	537	39	standard	standard	NOUN
ihlr-18810	537	40	for	for	ADP
ihlr-18810	537	41	clearance	clearance	NOUN
ihlr-18810	537	42	remains	remain	VERB
ihlr-18810	537	43	substantial	substantial	ADJ
ihlr-18810	537	44	equivalence	equivalence	NOUN
ihlr-18810	537	45	.	.	PUNCT
ihlr-18810	538	1	215	215	NUM
ihlr-18810	538	2	in	in	ADP
ihlr-18810	538	3	light	light	NOUN
ihlr-18810	538	4	of	of	ADP
ihlr-18810	538	5	this	this	DET
ihlr-18810	538	6	finding	finding	NOUN
ihlr-18810	538	7	,	,	PUNCT
ihlr-18810	538	8	it	it	PRON
ihlr-18810	538	9	recommended	recommend	VERB
ihlr-18810	538	10	the	the	DET
ihlr-18810	538	11	design	design	NOUN
ihlr-18810	538	12	of	of	ADP
ihlr-18810	538	13	a	a	DET
ihlr-18810	538	14	new	new	ADJ
ihlr-18810	538	15	regulatory	regulatory	ADJ
ihlr-18810	538	16	framework	framework	NOUN
ihlr-18810	538	17	enabling	enable	VERB
ihlr-18810	538	18	the	the	DET
ihlr-18810	538	19	510(k	510(k	PROPN
ihlr-18810	538	20	)	)	PUNCT
ihlr-18810	538	21	process	process	NOUN
ihlr-18810	538	22	to	to	PART
ihlr-18810	538	23	be	be	AUX
ihlr-18810	538	24	replaced	replace	VERB
ihlr-18810	538	25	with	with	ADP
ihlr-18810	538	26	a	a	DET
ihlr-18810	538	27	system	system	NOUN
ihlr-18810	538	28	that	that	PRON
ihlr-18810	538	29	provides	provide	VERB
ihlr-18810	538	30	a	a	DET
ihlr-18810	538	31	reasonable	reasonable	ADJ
ihlr-18810	538	32	assurance	assurance	NOUN
ihlr-18810	538	33	of	of	ADP
ihlr-18810	538	34	safety	safety	NOUN
ihlr-18810	538	35	and	and	CCONJ
ihlr-18810	538	36	effectiveness	effectiveness	NOUN
ihlr-18810	538	37	throughout	throughout	ADP
ihlr-18810	538	38	the	the	DET
ihlr-18810	538	39	device	device	NOUN
ihlr-18810	538	40	's	's	PART
ihlr-18810	538	41	life	life	NOUN
ihlr-18810	538	42	cycle	cycle	NOUN
ihlr-18810	538	43	.	.	PUNCT
ihlr-18810	539	1	216	216	NUM
ihlr-18810	539	2	the	the	DET
ihlr-18810	539	3	new	new	ADJ
ihlr-18810	539	4	system	system	NOUN
ihlr-18810	539	5	would	would	AUX
ihlr-18810	539	6	involve	involve	VERB
ihlr-18810	539	7	both	both	DET
ihlr-18810	539	8	pre	pre	ADJ
ihlr-18810	539	9	-	-	NOUN
ihlr-18810	539	10	market	market	ADJ
ihlr-18810	539	11	and	and	CCONJ
ihlr-18810	539	12	post	post	ADJ
ihlr-18810	539	13	-	-	ADJ
ihlr-18810	539	14	market	market	ADJ
ihlr-18810	539	15	regulation	regulation	NOUN
ihlr-18810	539	16	,	,	PUNCT
ihlr-18810	539	17	and	and	CCONJ
ihlr-18810	539	18	would	would	AUX
ihlr-18810	539	19	rely	rely	VERB
ihlr-18810	539	20	on	on	ADP
ihlr-18810	539	21	scientific	scientific	ADJ
ihlr-18810	539	22	evidence	evidence	NOUN
ihlr-18810	539	23	in	in	ADP
ihlr-18810	539	24	reaching	reach	VERB
ihlr-18810	539	25	determinations	determination	NOUN
ihlr-18810	539	26	of	of	ADP
ihlr-18810	539	27	safety	safety	NOUN
ihlr-18810	539	28	and	and	CCONJ
ihlr-18810	539	29	effectiveness	effectiveness	NOUN
ihlr-18810	539	30	.	.	PUNCT
ihlr-18810	540	1	2	2	NUM
ihlr-18810	540	2	17	17	NUM
ihlr-18810	540	3	although	although	SCONJ
ihlr-18810	540	4	the	the	DET
ihlr-18810	540	5	greater	great	ADJ
ihlr-18810	540	6	reliance	reliance	NOUN
ihlr-18810	540	7	on	on	ADP
ihlr-18810	540	8	scientific	scientific	ADJ
ihlr-18810	540	9	evidence	evidence	NOUN
ihlr-18810	540	10	and	and	CCONJ
ihlr-18810	540	11	clinical	clinical	ADJ
ihlr-18810	540	12	data	datum	NOUN
ihlr-18810	540	13	might	might	AUX
ihlr-18810	540	14	be	be	AUX
ihlr-18810	540	15	similar	similar	ADJ
ihlr-18810	540	16	to	to	ADP
ihlr-18810	540	17	the	the	DET
ihlr-18810	540	18	p1via	p1via	PROPN
ihlr-18810	540	19	process	process	NOUN
ihlr-18810	540	20	,	,	PUNCT
ihlr-18810	540	21	the	the	DET
ihlr-18810	540	22	proposed	propose	VERB
ihlr-18810	540	23	framework	framework	NOUN
ihlr-18810	540	24	would	would	AUX
ihlr-18810	540	25	focus	focus	VERB
ihlr-18810	540	26	most	most	ADJ
ihlr-18810	540	27	efforts	effort	NOUN
ihlr-18810	540	28	instead	instead	ADV
ihlr-18810	540	29	on	on	ADP
ihlr-18810	540	30	post	post	ADJ
ihlr-18810	540	31	-	-	ADJ
ihlr-18810	540	32	market	market	ADJ
ihlr-18810	540	33	surveillance	surveillance	NOUN
ihlr-18810	540	34	of	of	ADP
ihlr-18810	540	35	these	these	DET
ihlr-18810	540	36	devices	device	NOUN
ihlr-18810	540	37	,	,	PUNCT
ihlr-18810	540	38	and	and	CCONJ
ihlr-18810	540	39	in	in	ADP
ihlr-18810	540	40	that	that	DET
ihlr-18810	540	41	way	way	NOUN
ihlr-18810	540	42	maintain	maintain	VERB
ihlr-18810	540	43	both	both	DET
ihlr-18810	540	44	efficiency	efficiency	NOUN
ihlr-18810	540	45	in	in	ADP
ihlr-18810	540	46	the	the	DET
ihlr-18810	540	47	approval	approval	NOUN
ihlr-18810	540	48	process	process	NOUN
ihlr-18810	540	49	while	while	SCONJ
ihlr-18810	540	50	also	also	ADV
ihlr-18810	540	51	ensuring	ensure	VERB
ihlr-18810	540	52	the	the	DET
ihlr-18810	540	53	safety	safety	NOUN
ihlr-18810	540	54	of	of	ADP
ihlr-18810	540	55	these	these	DET
ihlr-18810	540	56	devices	device	NOUN
ihlr-18810	540	57	throughout	throughout	ADP
ihlr-18810	540	58	their	their	PRON
ihlr-18810	540	59	life	life	NOUN
ihlr-18810	540	60	cycle	cycle	NOUN
ihlr-18810	540	61	.	.	PUNCT
ihlr-18810	541	1	218	218	NUM
ihlr-18810	541	2	although	although	SCONJ
ihlr-18810	541	3	this	this	PRON
ihlr-18810	541	4	may	may	AUX
ihlr-18810	541	5	sound	sound	VERB
ihlr-18810	541	6	like	like	ADP
ihlr-18810	541	7	an	an	DET
ihlr-18810	541	8	effective	effective	ADJ
ihlr-18810	541	9	way	way	NOUN
ihlr-18810	541	10	to	to	PART
ihlr-18810	541	11	solve	solve	VERB
ihlr-18810	541	12	the	the	DET
ihlr-18810	541	13	issues	issue	NOUN
ihlr-18810	541	14	raised	raise	VERB
ihlr-18810	541	15	by	by	ADP
ihlr-18810	541	16	the	the	DET
ihlr-18810	541	17	510(k	510(k	PROPN
ihlr-18810	541	18	)	)	PUNCT
ihlr-18810	541	19	clearance	clearance	NOUN
ihlr-18810	541	20	process	process	NOUN
ihlr-18810	541	21	,	,	PUNCT
ihlr-18810	541	22	once	once	SCONJ
ihlr-18810	541	23	practical	practical	ADJ
ihlr-18810	541	24	concerns	concern	NOUN
ihlr-18810	541	25	are	be	AUX
ihlr-18810	541	26	addressed	address	VERB
ihlr-18810	541	27	it	it	PRON
ihlr-18810	541	28	becomes	become	VERB
ihlr-18810	541	29	apparent	apparent	ADJ
ihlr-18810	541	30	that	that	SCONJ
ihlr-18810	541	31	this	this	DET
ihlr-18810	541	32	recommendation	recommendation	NOUN
ihlr-18810	541	33	will	will	AUX
ihlr-18810	541	34	require	require	VERB
ihlr-18810	541	35	much	much	ADV
ihlr-18810	541	36	more	more	ADJ
ihlr-18810	541	37	than	than	ADP
ihlr-18810	541	38	congress	congress	PROPN
ihlr-18810	541	39	passing	pass	VERB
ihlr-18810	541	40	new	new	ADJ
ihlr-18810	541	41	legislation	legislation	NOUN
ihlr-18810	541	42	to	to	PART
ihlr-18810	541	43	effectuate	effectuate	VERB
ihlr-18810	541	44	the	the	DET
ihlr-18810	541	45	desired	desire	VERB
ihlr-18810	541	46	changes	change	NOUN
ihlr-18810	541	47	.	.	PUNCT
ihlr-18810	542	1	it	it	PRON
ihlr-18810	542	2	can	can	AUX
ihlr-18810	542	3	not	not	PART
ihlr-18810	542	4	be	be	AUX
ihlr-18810	542	5	forgotten	forget	VERB
ihlr-18810	542	6	that	that	SCONJ
ihlr-18810	542	7	the	the	DET
ihlr-18810	542	8	fda	fda	PROPN
ihlr-18810	542	9	is	be	AUX
ihlr-18810	542	10	an	an	DET
ihlr-18810	542	11	already	already	ADV
ihlr-18810	542	12	overburdened	overburden	VERB
ihlr-18810	542	13	agency	agency	NOUN
ihlr-18810	542	14	with	with	ADP
ihlr-18810	542	15	limited	limited	ADJ
ihlr-18810	542	16	resources	resource	NOUN
ihlr-18810	542	17	available	available	ADJ
ihlr-18810	542	18	to	to	ADP
ihlr-18810	542	19	it	it	PRON
ihlr-18810	542	20	.	.	PUNCT
ihlr-18810	543	1	as	as	SCONJ
ihlr-18810	543	2	pointed	point	VERB
ihlr-18810	543	3	out	out	ADP
ihlr-18810	543	4	above	above	ADV
ihlr-18810	543	5	,	,	PUNCT
ihlr-18810	543	6	510(k	510(k	NUM
ihlr-18810	543	7	)	)	PUNCT
ihlr-18810	543	8	pre	pre	ADJ
ihlr-18810	543	9	-	-	ADJ
ihlr-18810	543	10	market	market	ADJ
ihlr-18810	543	11	notification	notification	NOUN
ihlr-18810	543	12	has	have	AUX
ihlr-18810	543	13	been	be	AUX
ihlr-18810	543	14	helpful	helpful	ADJ
ihlr-18810	543	15	to	to	ADP
ihlr-18810	543	16	both	both	CCONJ
ihlr-18810	543	17	the	the	DET
ihlr-18810	543	18	fda	fda	PROPN
ihlr-18810	543	19	and	and	CCONJ
ihlr-18810	543	20	to	to	ADP
ihlr-18810	543	21	the	the	DET
ihlr-18810	543	22	medical	medical	ADJ
ihlr-18810	543	23	device	device	NOUN
ihlr-18810	543	24	industry	industry	NOUN
ihlr-18810	543	25	because	because	SCONJ
ihlr-18810	543	26	it	it	PRON
ihlr-18810	543	27	offers	offer	VERB
ihlr-18810	543	28	a	a	DET
ihlr-18810	543	29	quicker	quick	ADJ
ihlr-18810	543	30	way	way	NOUN
ihlr-18810	543	31	to	to	PART
ihlr-18810	543	32	bring	bring	VERB
ihlr-18810	543	33	devices	device	NOUN
ihlr-18810	543	34	to	to	ADP
ihlr-18810	543	35	market	market	NOUN
ihlr-18810	543	36	which	which	PRON
ihlr-18810	543	37	requires	require	VERB
ihlr-18810	543	38	the	the	DET
ihlr-18810	543	39	filing	filing	NOUN
ihlr-18810	543	40	of	of	ADP
ihlr-18810	543	41	less	less	ADJ
ihlr-18810	543	42	information	information	NOUN
ihlr-18810	543	43	,	,	PUNCT
ihlr-18810	543	44	and	and	CCONJ
ihlr-18810	543	45	fewer	few	ADJ
ihlr-18810	543	46	hours	hour	NOUN
ihlr-18810	543	47	of	of	ADP
ihlr-18810	543	48	analysis	analysis	NOUN
ihlr-18810	543	49	,	,	PUNCT
ihlr-18810	543	50	before	before	ADP
ihlr-18810	543	51	clearance	clearance	NOUN
ihlr-18810	543	52	.	.	PUNCT
ihlr-18810	544	1	although	although	SCONJ
ihlr-18810	544	2	it	it	PRON
ihlr-18810	544	3	may	may	AUX
ihlr-18810	544	4	be	be	AUX
ihlr-18810	544	5	desirable	desirable	ADJ
ihlr-18810	544	6	to	to	PART
ihlr-18810	544	7	increase	increase	VERB
ihlr-18810	544	8	the	the	DET
ihlr-18810	544	9	depth	depth	NOUN
ihlr-18810	544	10	of	of	ADP
ihlr-18810	544	11	analysis	analysis	NOUN
ihlr-18810	544	12	under	under	ADV
ihlr-18810	544	13	-	-	PUNCT
ihlr-18810	544	14	taken	take	VERB
ihlr-18810	544	15	214	214	NUM
ihlr-18810	545	1	i	i	PRON
ihlr-18810	545	2	d.	d.	PROPN
ihlr-18810	545	3	at	at	ADP
ihlr-18810	545	4	16	16	NUM
ihlr-18810	545	5	.	.	PUNCT
ihlr-18810	546	1	215	215	NUM
ihlr-18810	547	1	i	i	PRON
ihlr-18810	547	2	d.	d.	NOUN
ihlr-18810	547	3	at	at	ADP
ihlr-18810	547	4	193	193	NUM
ihlr-18810	547	5	.	.	PUNCT
ihlr-18810	548	1	216	216	NUM
ihlr-18810	548	2	i	i	PRON
ihlr-18810	548	3	d.	d.	PROPN
ihlr-18810	548	4	at	at	ADP
ihlr-18810	548	5	196	196	NUM
ihlr-18810	548	6	.	.	PUNCT
ihlr-18810	549	1	217	217	NUM
ihlr-18810	550	1	i	i	PRON
ihlr-18810	550	2	d.	d.	PROPN
ihlr-18810	550	3	218	218	NUM
ihlr-18810	551	1	i	i	PRON
ihlr-18810	551	2	d.	d.	PROPN
ihlr-18810	551	3	at	at	ADP
ihlr-18810	551	4	197	197	NUM
ihlr-18810	551	5	-	-	SYM
ihlr-18810	551	6	99	99	NUM
ihlr-18810	551	7	.	.	PUNCT
ihlr-18810	552	1	2013	2013	NUM
ihlr-18810	552	2	153	153	NUM
ihlr-18810	552	3	indiana	indiana	PROPN
ihlr-18810	552	4	health	health	PROPN
ihlr-18810	552	5	law	law	PROPN
ihlr-18810	552	6	review	review	NOUN
ihlr-18810	552	7	by	by	ADP
ihlr-18810	552	8	the	the	DET
ihlr-18810	552	9	fda	fda	PROPN
ihlr-18810	552	10	before	before	SCONJ
ihlr-18810	552	11	these	these	DET
ihlr-18810	552	12	devices	device	NOUN
ihlr-18810	552	13	go	go	VERB
ihlr-18810	552	14	to	to	ADP
ihlr-18810	552	15	market	market	NOUN
ihlr-18810	552	16	,	,	PUNCT
ihlr-18810	552	17	because	because	SCONJ
ihlr-18810	552	18	of	of	ADP
ihlr-18810	552	19	the	the	DET
ihlr-18810	552	20	fda	fda	PROPN
ihlr-18810	552	21	's	's	PART
ihlr-18810	552	22	limited	limited	ADJ
ihlr-18810	552	23	resources	resource	NOUN
ihlr-18810	552	24	,	,	PUNCT
ihlr-18810	552	25	the	the	DET
ihlr-18810	552	26	likely	likely	ADJ
ihlr-18810	552	27	effect	effect	NOUN
ihlr-18810	552	28	will	will	AUX
ihlr-18810	552	29	simply	simply	ADV
ihlr-18810	552	30	be	be	AUX
ihlr-18810	552	31	a	a	DET
ihlr-18810	552	32	notable	notable	ADJ
ihlr-18810	552	33	increase	increase	NOUN
ihlr-18810	552	34	in	in	ADP
ihlr-18810	552	35	the	the	DET
ihlr-18810	552	36	delay	delay	NOUN
ihlr-18810	552	37	before	before	SCONJ
ihlr-18810	552	38	the	the	DET
ihlr-18810	552	39	device	device	NOUN
ihlr-18810	552	40	actually	actually	ADV
ihlr-18810	552	41	comes	come	VERB
ihlr-18810	552	42	to	to	ADP
ihlr-18810	552	43	the	the	DET
ihlr-18810	552	44	market	market	NOUN
ihlr-18810	552	45	and	and	CCONJ
ihlr-18810	552	46	becomes	become	VERB
ihlr-18810	552	47	available	available	ADJ
ihlr-18810	552	48	to	to	ADP
ihlr-18810	552	49	patients	patient	NOUN
ihlr-18810	552	50	in	in	ADP
ihlr-18810	552	51	need	need	NOUN
ihlr-18810	552	52	of	of	ADP
ihlr-18810	552	53	these	these	DET
ihlr-18810	552	54	treatments	treatment	NOUN
ihlr-18810	552	55	.	.	PUNCT
ihlr-18810	553	1	medical	medical	ADJ
ihlr-18810	553	2	tourism	tourism	NOUN
ihlr-18810	553	3	already	already	ADV
ihlr-18810	553	4	occurs	occur	VERB
ihlr-18810	553	5	due	due	ADP
ihlr-18810	553	6	to	to	ADP
ihlr-18810	553	7	the	the	DET
ihlr-18810	553	8	delay	delay	NOUN
ihlr-18810	553	9	in	in	ADP
ihlr-18810	553	10	the	the	DET
ihlr-18810	553	11	approval	approval	NOUN
ihlr-18810	553	12	of	of	ADP
ihlr-18810	553	13	devices	device	NOUN
ihlr-18810	553	14	for	for	ADP
ihlr-18810	553	15	market	market	NOUN
ihlr-18810	553	16	in	in	ADP
ihlr-18810	553	17	the	the	DET
ihlr-18810	553	18	u.s.219	u.s.219	NOUN
ihlr-18810	553	19	this	this	DET
ihlr-18810	553	20	effect	effect	NOUN
ihlr-18810	553	21	is	be	AUX
ihlr-18810	553	22	further	far	ADV
ihlr-18810	553	23	exacerbated	exacerbate	VERB
ihlr-18810	553	24	by	by	ADP
ihlr-18810	553	25	manu	manu	NOUN
ihlr-18810	553	26	-	-	PUNCT
ihlr-18810	553	27	facturers	facturer	NOUN
ihlr-18810	553	28	considering	consider	VERB
ihlr-18810	553	29	marketing	market	VERB
ihlr-18810	553	30	their	their	PRON
ihlr-18810	553	31	devices	device	NOUN
ihlr-18810	553	32	only	only	ADV
ihlr-18810	553	33	abroad	abroad	ADV
ihlr-18810	553	34	,	,	PUNCT
ihlr-18810	553	35	forgoing	forgo	VERB
ihlr-18810	553	36	the	the	DET
ihlr-18810	553	37	u.s	u.s	PROPN
ihlr-18810	553	38	.	.	PROPN
ihlr-18810	553	39	market	market	NOUN
ihlr-18810	553	40	and	and	CCONJ
ihlr-18810	553	41	fda	fda	PROPN
ihlr-18810	553	42	regulation	regulation	NOUN
ihlr-18810	553	43	entirely	entirely	ADV
ihlr-18810	553	44	.	.	PUNCT
ihlr-18810	554	1	220	220	NUM
ihlr-18810	554	2	additionally	additionally	ADV
ihlr-18810	554	3	,	,	PUNCT
ihlr-18810	554	4	the	the	DET
ihlr-18810	554	5	"	"	PUNCT
ihlr-18810	554	6	leniency	leniency	NOUN
ihlr-18810	554	7	"	"	PUNCT
ihlr-18810	554	8	of	of	ADP
ihlr-18810	554	9	medical	medical	ADJ
ihlr-18810	554	10	device	device	NOUN
ihlr-18810	554	11	regu	regu	NOUN
ihlr-18810	554	12	-	-	PUNCT
ihlr-18810	554	13	lation	lation	NOUN
ihlr-18810	554	14	in	in	ADP
ihlr-18810	554	15	europe	europe	PROPN
ihlr-18810	554	16	,	,	PUNCT
ihlr-18810	554	17	and	and	CCONJ
ihlr-18810	554	18	its	its	PRON
ihlr-18810	554	19	consequential	consequential	ADJ
ihlr-18810	554	20	speed	speed	NOUN
ihlr-18810	554	21	and	and	CCONJ
ihlr-18810	554	22	efficiency	efficiency	NOUN
ihlr-18810	554	23	,	,	PUNCT
ihlr-18810	554	24	have	have	AUX
ihlr-18810	554	25	not	not	PART
ihlr-18810	554	26	demonstrated	demonstrate	VERB
ihlr-18810	554	27	a	a	DET
ihlr-18810	554	28	resulting	result	VERB
ihlr-18810	554	29	harm	harm	NOUN
ihlr-18810	554	30	to	to	ADP
ihlr-18810	554	31	patient	patient	NOUN
ihlr-18810	554	32	safety	safety	NOUN
ihlr-18810	554	33	,	,	PUNCT
ihlr-18810	554	34	as	as	SCONJ
ihlr-18810	554	35	evidenced	evidence	VERB
ihlr-18810	554	36	by	by	ADP
ihlr-18810	554	37	the	the	DET
ihlr-18810	554	38	almost	almost	ADV
ihlr-18810	554	39	equal	equal	ADJ
ihlr-18810	554	40	rates	rate	NOUN
ihlr-18810	554	41	of	of	ADP
ihlr-18810	554	42	device	device	NOUN
ihlr-18810	554	43	recalls	recall	VERB
ihlr-18810	554	44	in	in	ADP
ihlr-18810	554	45	the	the	DET
ihlr-18810	554	46	u.s	u.s	PROPN
ihlr-18810	554	47	.	.	PROPN
ihlr-18810	554	48	and	and	CCONJ
ihlr-18810	554	49	europe.221	europe.221	NOUN
ihlr-18810	554	50	therefore	therefore	ADV
ihlr-18810	554	51	,	,	PUNCT
ihlr-18810	554	52	additional	additional	ADJ
ihlr-18810	554	53	pre	pre	ADJ
ihlr-18810	554	54	-	-	ADJ
ihlr-18810	554	55	market	market	ADJ
ihlr-18810	554	56	study	study	NOUN
ihlr-18810	554	57	and	and	CCONJ
ihlr-18810	554	58	analysis	analysis	NOUN
ihlr-18810	554	59	will	will	AUX
ihlr-18810	554	60	not	not	PART
ihlr-18810	554	61	necessarily	necessarily	ADV
ihlr-18810	554	62	assure	assure	VERB
ihlr-18810	554	63	the	the	DET
ihlr-18810	554	64	safety	safety	NOUN
ihlr-18810	554	65	and	and	CCONJ
ihlr-18810	554	66	efficacy	efficacy	NOUN
ihlr-18810	554	67	of	of	ADP
ihlr-18810	554	68	devices	device	NOUN
ihlr-18810	554	69	.	.	PUNCT
ihlr-18810	555	1	but	but	CCONJ
ihlr-18810	555	2	adding	add	VERB
ihlr-18810	555	3	additional	additional	ADJ
ihlr-18810	555	4	barriers	barrier	NOUN
ihlr-18810	555	5	before	before	SCONJ
ihlr-18810	555	6	a	a	DET
ihlr-18810	555	7	device	device	NOUN
ihlr-18810	555	8	first	first	ADV
ihlr-18810	555	9	reaches	reach	VERB
ihlr-18810	555	10	the	the	DET
ihlr-18810	555	11	market	market	NOUN
ihlr-18810	555	12	will	will	AUX
ihlr-18810	555	13	harm	harm	VERB
ihlr-18810	555	14	both	both	CCONJ
ihlr-18810	555	15	the	the	DET
ihlr-18810	555	16	med	med	ADJ
ihlr-18810	555	17	-	-	PUNCT
ihlr-18810	555	18	ical	ical	ADJ
ihlr-18810	555	19	device	device	NOUN
ihlr-18810	555	20	industry	industry	NOUN
ihlr-18810	555	21	and	and	CCONJ
ihlr-18810	555	22	american	american	ADJ
ihlr-18810	555	23	patients	patient	NOUN
ihlr-18810	555	24	by	by	ADP
ihlr-18810	555	25	increasing	increase	VERB
ihlr-18810	555	26	the	the	DET
ihlr-18810	555	27	time	time	NOUN
ihlr-18810	555	28	before	before	SCONJ
ihlr-18810	555	29	the	the	DET
ihlr-18810	555	30	device	device	NOUN
ihlr-18810	555	31	is	be	AUX
ihlr-18810	555	32	available	available	ADJ
ihlr-18810	555	33	.	.	PUNCT
ihlr-18810	556	1	219	219	NUM
ihlr-18810	556	2	i.	i.	PROPN
ihlr-18810	556	3	glenn	glenn	PROPN
ihlr-18810	556	4	cohen	cohen	PROPN
ihlr-18810	556	5	,	,	PUNCT
ihlr-18810	556	6	protecting	protect	VERB
ihlr-18810	556	7	patients	patient	NOUN
ihlr-18810	556	8	with	with	ADP
ihlr-18810	556	9	passports	passport	NOUN
ihlr-18810	556	10	:	:	PUNCT
ihlr-18810	556	11	medical	medical	ADJ
ihlr-18810	556	12	tourism	tourism	NOUN
ihlr-18810	556	13	and	and	CCONJ
ihlr-18810	556	14	the	the	DET
ihlr-18810	556	15	patient	patient	NOUN
ihlr-18810	556	16	-	-	PUNCT
ihlr-18810	556	17	protective	protective	ADJ
ihlr-18810	556	18	argument	argument	NOUN
ihlr-18810	556	19	,	,	PUNCT
ihlr-18810	556	20	95	95	NUM
ihlr-18810	556	21	iowa	iowa	PROPN
ihlr-18810	556	22	l.	l.	PROPN
ihlr-18810	556	23	rev	rev	PROPN
ihlr-18810	556	24	.	.	PROPN
ihlr-18810	556	25	1467	1467	NUM
ihlr-18810	556	26	,	,	PUNCT
ihlr-18810	556	27	1471	1471	NUM
ihlr-18810	556	28	(	(	PUNCT
ihlr-18810	556	29	2010	2010	NUM
ihlr-18810	556	30	)	)	PUNCT
ihlr-18810	556	31	.	.	PUNCT
ihlr-18810	557	1	medical	medical	ADJ
ihlr-18810	557	2	tourism	tourism	NOUN
ihlr-18810	557	3	describes	describe	VERB
ihlr-18810	557	4	the	the	DET
ihlr-18810	557	5	phenomenon	phenomenon	NOUN
ihlr-18810	557	6	by	by	ADP
ihlr-18810	557	7	which	which	PRON
ihlr-18810	557	8	patients	patient	NOUN
ihlr-18810	557	9	of	of	ADP
ihlr-18810	557	10	one	one	NUM
ihlr-18810	557	11	country	country	NOUN
ihlr-18810	557	12	will	will	AUX
ihlr-18810	557	13	choose	choose	VERB
ihlr-18810	557	14	to	to	PART
ihlr-18810	557	15	travel	travel	VERB
ihlr-18810	557	16	abroad	abroad	ADV
ihlr-18810	557	17	to	to	PART
ihlr-18810	557	18	receive	receive	VERB
ihlr-18810	557	19	their	their	PRON
ihlr-18810	557	20	medical	medical	ADJ
ihlr-18810	557	21	care	care	NOUN
ihlr-18810	557	22	.	.	PUNCT
ihlr-18810	558	1	there	there	PRON
ihlr-18810	558	2	can	can	AUX
ihlr-18810	558	3	be	be	AUX
ihlr-18810	558	4	a	a	DET
ihlr-18810	558	5	number	number	NOUN
ihlr-18810	558	6	of	of	ADP
ihlr-18810	558	7	reasons	reason	NOUN
ihlr-18810	558	8	a	a	DET
ihlr-18810	558	9	patient	patient	NOUN
ihlr-18810	558	10	would	would	AUX
ihlr-18810	558	11	decide	decide	VERB
ihlr-18810	558	12	to	to	PART
ihlr-18810	558	13	engage	engage	VERB
ihlr-18810	558	14	in	in	ADP
ihlr-18810	558	15	medical	medical	ADJ
ihlr-18810	558	16	tourism	tourism	NOUN
ihlr-18810	558	17	.	.	PUNCT
ihlr-18810	559	1	oftentimes	oftentime	NOUN
ihlr-18810	559	2	,	,	PUNCT
ihlr-18810	559	3	patients	patient	NOUN
ihlr-18810	559	4	who	who	PRON
ihlr-18810	559	5	are	be	AUX
ihlr-18810	559	6	uninsured	uninsured	ADJ
ihlr-18810	559	7	or	or	CCONJ
ihlr-18810	559	8	underinsured	underinsured	ADJ
ihlr-18810	559	9	may	may	AUX
ihlr-18810	559	10	choose	choose	VERB
ihlr-18810	559	11	to	to	PART
ihlr-18810	559	12	travel	travel	VERB
ihlr-18810	559	13	to	to	ADP
ihlr-18810	559	14	countries	country	NOUN
ihlr-18810	559	15	offering	offer	VERB
ihlr-18810	559	16	the	the	DET
ihlr-18810	559	17	required	required	ADJ
ihlr-18810	559	18	treatment	treatment	NOUN
ihlr-18810	559	19	at	at	ADP
ihlr-18810	559	20	a	a	DET
ihlr-18810	559	21	much	much	ADV
ihlr-18810	559	22	more	more	ADJ
ihlr-18810	559	23	affordable	affordable	ADJ
ihlr-18810	559	24	price	price	NOUN
ihlr-18810	559	25	.	.	PUNCT
ihlr-18810	560	1	additionally	additionally	ADV
ihlr-18810	560	2	,	,	PUNCT
ihlr-18810	560	3	patients	patient	NOUN
ihlr-18810	560	4	may	may	AUX
ihlr-18810	560	5	be	be	AUX
ihlr-18810	560	6	drawn	draw	VERB
ihlr-18810	560	7	to	to	PART
ihlr-18810	560	8	travel	travel	VERB
ihlr-18810	560	9	abroad	abroad	ADV
ihlr-18810	560	10	because	because	SCONJ
ihlr-18810	560	11	of	of	ADP
ihlr-18810	560	12	the	the	DET
ihlr-18810	560	13	increased	increase	VERB
ihlr-18810	560	14	privacy	privacy	NOUN
ihlr-18810	560	15	the	the	DET
ihlr-18810	560	16	foreign	foreign	ADJ
ihlr-18810	560	17	locations	location	NOUN
ihlr-18810	560	18	offer	offer	VERB
ihlr-18810	560	19	.	.	PUNCT
ihlr-18810	561	1	most	most	ADV
ihlr-18810	561	2	important	important	ADJ
ihlr-18810	561	3	to	to	ADP
ihlr-18810	561	4	medical	medical	ADJ
ihlr-18810	561	5	device	device	NOUN
ihlr-18810	561	6	regulation	regulation	NOUN
ihlr-18810	561	7	,	,	PUNCT
ihlr-18810	561	8	however	however	ADV
ihlr-18810	561	9	,	,	PUNCT
ihlr-18810	561	10	are	be	AUX
ihlr-18810	561	11	the	the	DET
ihlr-18810	561	12	occurrences	occurrence	NOUN
ihlr-18810	561	13	in	in	ADP
ihlr-18810	561	14	which	which	PRON
ihlr-18810	561	15	patients	patient	NOUN
ihlr-18810	561	16	who	who	PRON
ihlr-18810	561	17	can	can	AUX
ihlr-18810	561	18	not	not	PART
ihlr-18810	561	19	access	access	VERB
ihlr-18810	561	20	needed	need	VERB
ihlr-18810	561	21	treatments	treatment	NOUN
ihlr-18810	561	22	in	in	ADP
ihlr-18810	561	23	their	their	PRON
ihlr-18810	561	24	home	home	NOUN
ihlr-18810	561	25	countries	country	NOUN
ihlr-18810	561	26	will	will	AUX
ihlr-18810	561	27	travel	travel	VERB
ihlr-18810	561	28	abroad	abroad	ADV
ihlr-18810	561	29	to	to	PART
ihlr-18810	561	30	receive	receive	VERB
ihlr-18810	561	31	treatment	treatment	NOUN
ihlr-18810	561	32	in	in	ADP
ihlr-18810	561	33	countries	country	NOUN
ihlr-18810	561	34	which	which	PRON
ihlr-18810	561	35	have	have	VERB
ihlr-18810	561	36	a	a	DET
ihlr-18810	561	37	quicker	quick	ADJ
ihlr-18810	561	38	or	or	CCONJ
ihlr-18810	561	39	less	less	ADV
ihlr-18810	561	40	regulated	regulated	ADJ
ihlr-18810	561	41	medical	medical	ADJ
ihlr-18810	561	42	device	device	NOUN
ihlr-18810	561	43	market	market	NOUN
ihlr-18810	561	44	and	and	CCONJ
ihlr-18810	561	45	access	access	NOUN
ihlr-18810	561	46	devices	device	NOUN
ihlr-18810	561	47	there	there	ADV
ihlr-18810	561	48	which	which	PRON
ihlr-18810	561	49	are	be	AUX
ihlr-18810	561	50	not	not	PART
ihlr-18810	561	51	approved	approve	VERB
ihlr-18810	561	52	for	for	ADP
ihlr-18810	561	53	the	the	DET
ihlr-18810	561	54	american	american	ADJ
ihlr-18810	561	55	market	market	NOUN
ihlr-18810	561	56	.	.	PUNCT
ihlr-18810	562	1	see	see	VERB
ihlr-18810	562	2	generally	generally	ADV
ihlr-18810	562	3	andrew	andrew	PROPN
ihlr-18810	562	4	pollack	pollack	PROPN
ihlr-18810	562	5	,	,	PUNCT
ihlr-18810	562	6	medical	medical	ADJ
ihlr-18810	562	7	treatment	treatment	NOUN
ihlr-18810	562	8	,	,	PUNCT
ihlr-18810	562	9	out	out	ADP
ihlr-18810	562	10	of	of	ADP
ihlr-18810	562	11	reach	reach	NOUN
ihlr-18810	562	12	,	,	PUNCT
ihlr-18810	562	13	n.y	n.y	PROPN
ihlr-18810	562	14	.	.	PROPN
ihlr-18810	562	15	times	times	PROPN
ihlr-18810	562	16	,	,	PUNCT
ihlr-18810	562	17	feb	feb	PROPN
ihlr-18810	562	18	.	.	PROPN
ihlr-18810	562	19	10	10	NUM
ihlr-18810	562	20	,	,	PUNCT
ihlr-18810	562	21	2011	2011	NUM
ihlr-18810	562	22	,	,	PUNCT
ihlr-18810	562	23	at	at	ADP
ihlr-18810	562	24	bi	bi	NOUN
ihlr-18810	562	25	,	,	PUNCT
ihlr-18810	562	26	http://www.nytimes	http://www.nytime	NOUN
ihlr-18810	562	27	.	.	PUNCT
ihlr-18810	562	28	com/2011/02/10	com/2011/02/10	PUNCT
ihlr-18810	562	29	/	/	SYM
ihlr-18810	562	30	business	business	NOUN
ihlr-18810	562	31	/	/	SYM
ihlr-18810	562	32	lodevice.html?pagewanted	lodevice.html?pagewante	VERB
ihlr-18810	562	33	=	=	NOUN
ihlr-18810	562	34	all	all	PRON
ihlr-18810	562	35	(	(	PUNCT
ihlr-18810	562	36	last	last	ADV
ihlr-18810	562	37	visited	visit	VERB
ihlr-18810	562	38	dec	dec	PROPN
ihlr-18810	562	39	.	.	PROPN
ihlr-18810	562	40	27	27	NUM
ihlr-18810	562	41	,	,	PUNCT
ihlr-18810	562	42	2012	2012	NUM
ihlr-18810	562	43	)	)	PUNCT
ihlr-18810	562	44	.	.	PUNCT
ihlr-18810	563	1	220	220	NUM
ihlr-18810	564	1	i	i	PRON
ihlr-18810	564	2	d.	d.	PROPN
ihlr-18810	564	3	221	221	NUM
ihlr-18810	565	1	scott	scott	PROPN
ihlr-18810	565	2	davis	davis	PROPN
ihlr-18810	565	3	et	et	PROPN
ihlr-18810	565	4	al	al	PROPN
ihlr-18810	565	5	.	.	PROPN
ihlr-18810	565	6	,	,	PUNCT
ihlr-18810	565	7	eu	eu	PROPN
ihlr-18810	565	8	medical	medical	ADJ
ihlr-18810	565	9	device	device	NOUN
ihlr-18810	565	10	approval	approval	NOUN
ihlr-18810	565	11	safety	safety	NOUN
ihlr-18810	565	12	assessment	assessment	NOUN
ihlr-18810	565	13	:	:	PUNCT
ihlr-18810	565	14	a	a	DET
ihlr-18810	565	15	comparative	comparative	ADJ
ihlr-18810	565	16	analysis	analysis	NOUN
ihlr-18810	565	17	of	of	ADP
ihlr-18810	565	18	medical	medical	ADJ
ihlr-18810	565	19	device	device	NOUN
ihlr-18810	565	20	recalls	recall	VERB
ihlr-18810	565	21	2005	2005	NUM
ihlr-18810	565	22	-	-	SYM
ihlr-18810	565	23	2009	2009	NUM
ihlr-18810	565	24	9	9	NUM
ihlr-18810	565	25	(	(	PUNCT
ihlr-18810	565	26	2011	2011	NUM
ihlr-18810	565	27	)	)	PUNCT
ihlr-18810	565	28	,	,	PUNCT
ihlr-18810	565	29	available	available	ADJ
ihlr-18810	565	30	at	at	ADP
ihlr-18810	565	31	http://www.commerce.gov/	http://www.commerce.gov/	NOUN
ihlr-18810	565	32	sites	site	NOUN
ihlr-18810	565	33	/	/	SYM
ihlr-18810	565	34	default/	default/	NUM
ihlr-18810	565	35	files	file	NOUN
ihlr-18810	565	36	/	/	SYM
ihlr-18810	565	37	documents/201	documents/201	NOUN
ihlr-18810	565	38	1	1	NUM
ihlr-18810	565	39	/	/	SYM
ihlr-18810	565	40	july	july	PROPN
ihlr-18810	565	41	/	/	SYM
ihlr-18810	565	42	report	report	NOUN
ihlr-18810	565	43	-	-	PUNCT
ihlr-18810	565	44	european	european	ADJ
ihlr-18810	565	45	-	-	PUNCT
ihlr-18810	565	46	us	us	PROPN
ihlr-18810	565	47	medical	medical	ADJ
ihlr-18810	565	48	devicesafety_0	devicesafety_0	PROPN
ihlr-18810	566	1	.	.	PUNCT
ihlr-18810	566	2	pdf	pdf	NOUN
ihlr-18810	566	3	.	.	PUNCT
ihlr-18810	567	1	154	154	NUM
ihlr-18810	567	2	vol	vol	NOUN
ihlr-18810	567	3	.	.	PUNCT
ihlr-18810	568	1	10:1	10:1	NUM
ihlr-18810	568	2	510(k	510(k	NUM
ihlr-18810	568	3	)	)	PUNCT
ihlr-18810	568	4	clearance	clearance	NOUN
ihlr-18810	568	5	additionally	additionally	ADV
ihlr-18810	568	6	,	,	PUNCT
ihlr-18810	568	7	the	the	DET
ihlr-18810	568	8	cphe	cphe	NOUN
ihlr-18810	568	9	called	call	VERB
ihlr-18810	568	10	upon	upon	SCONJ
ihlr-18810	568	11	the	the	DET
ihlr-18810	568	12	fda	fda	PROPN
ihlr-18810	568	13	to	to	PART
ihlr-18810	568	14	improve	improve	VERB
ihlr-18810	568	15	the	the	DET
ihlr-18810	568	16	post	post	ADJ
ihlr-18810	568	17	-	-	ADJ
ihlr-18810	568	18	market	market	ADJ
ihlr-18810	568	19	performance	performance	NOUN
ihlr-18810	568	20	surveillance	surveillance	NOUN
ihlr-18810	568	21	of	of	ADP
ihlr-18810	568	22	devices	device	NOUN
ihlr-18810	568	23	by	by	ADP
ihlr-18810	568	24	improving	improve	VERB
ihlr-18810	568	25	its	its	PRON
ihlr-18810	568	26	strategy	strategy	NOUN
ihlr-18810	568	27	for	for	ADP
ihlr-18810	568	28	collecting	collecting	NOUN
ihlr-18810	568	29	,	,	PUNCT
ihlr-18810	568	30	analyzing	analyzing	NOUN
ihlr-18810	568	31	,	,	PUNCT
ihlr-18810	568	32	and	and	CCONJ
ihlr-18810	568	33	acting	act	VERB
ihlr-18810	568	34	on	on	ADP
ihlr-18810	568	35	device	device	NOUN
ihlr-18810	568	36	post	post	ADJ
ihlr-18810	568	37	-	-	ADJ
ihlr-18810	568	38	market	market	ADJ
ihlr-18810	568	39	performance	performance	NOUN
ihlr-18810	568	40	information	information	NOUN
ihlr-18810	568	41	,	,	PUNCT
ihlr-18810	568	42	and	and	CCONJ
ihlr-18810	568	43	to	to	PART
ihlr-18810	568	44	make	make	VERB
ihlr-18810	568	45	better	well	ADJ
ihlr-18810	568	46	use	use	NOUN
ihlr-18810	568	47	of	of	ADP
ihlr-18810	568	48	its	its	PRON
ihlr-18810	568	49	post	post	ADJ
ihlr-18810	568	50	-	-	ADJ
ihlr-18810	568	51	market	market	ADJ
ihlr-18810	568	52	regulatory	regulatory	ADJ
ihlr-18810	568	53	authority	authority	NOUN
ihlr-18810	568	54	.	.	PUNCT
ihlr-18810	569	1	22	22	NUM
ihlr-18810	569	2	2	2	NUM
ihlr-18810	569	3	recommendations	recommendation	NOUN
ihlr-18810	569	4	were	be	AUX
ihlr-18810	569	5	also	also	ADV
ihlr-18810	569	6	made	make	VERB
ihlr-18810	569	7	for	for	SCONJ
ihlr-18810	569	8	the	the	DET
ihlr-18810	569	9	fda	fda	PROPN
ihlr-18810	569	10	to	to	PART
ihlr-18810	569	11	implement	implement	VERB
ihlr-18810	569	12	a	a	DET
ihlr-18810	569	13	continuous	continuous	ADJ
ihlr-18810	569	14	quality	quality	NOUN
ihlr-18810	569	15	-	-	PUNCT
ihlr-18810	569	16	improvement	improvement	NOUN
ihlr-18810	569	17	program	program	NOUN
ihlr-18810	569	18	and	and	CCONJ
ihlr-18810	569	19	develop	develop	VERB
ihlr-18810	569	20	procedures	procedure	NOUN
ihlr-18810	569	21	to	to	PART
ihlr-18810	569	22	evaluate	evaluate	VERB
ihlr-18810	569	23	the	the	DET
ihlr-18810	569	24	safety	safety	NOUN
ihlr-18810	569	25	and	and	CCONJ
ihlr-18810	569	26	effectiveness	effectiveness	NOUN
ihlr-18810	569	27	of	of	ADP
ihlr-18810	569	28	software	software	NOUN
ihlr-18810	569	29	used	use	VERB
ihlr-18810	569	30	by	by	ADP
ihlr-18810	569	31	devices	device	NOUN
ihlr-18810	569	32	as	as	ADV
ihlr-18810	569	33	well	well	ADV
ihlr-18810	569	34	.	.	PUNCT
ihlr-18810	570	1	223	223	NUM
ihlr-18810	571	1	these	these	DET
ihlr-18810	571	2	measures	measure	NOUN
ihlr-18810	571	3	will	will	AUX
ihlr-18810	571	4	not	not	PART
ihlr-18810	571	5	alone	alone	ADV
ihlr-18810	571	6	be	be	AUX
ihlr-18810	571	7	sufficient	sufficient	ADJ
ihlr-18810	571	8	,	,	PUNCT
ihlr-18810	571	9	however	however	ADV
ihlr-18810	571	10	,	,	PUNCT
ihlr-18810	571	11	to	to	PART
ihlr-18810	571	12	ensure	ensure	VERB
ihlr-18810	571	13	the	the	DET
ihlr-18810	571	14	safety	safety	NOUN
ihlr-18810	571	15	and	and	CCONJ
ihlr-18810	571	16	efficacy	efficacy	NOUN
ihlr-18810	571	17	of	of	ADP
ihlr-18810	571	18	medical	medical	ADJ
ihlr-18810	571	19	devices	device	NOUN
ihlr-18810	571	20	on	on	ADP
ihlr-18810	571	21	the	the	DET
ihlr-18810	571	22	market	market	NOUN
ihlr-18810	571	23	today	today	NOUN
ihlr-18810	571	24	and	and	CCONJ
ihlr-18810	571	25	in	in	ADP
ihlr-18810	571	26	the	the	DET
ihlr-18810	571	27	future	future	NOUN
ihlr-18810	571	28	,	,	PUNCT
ihlr-18810	571	29	as	as	SCONJ
ihlr-18810	571	30	they	they	PRON
ihlr-18810	571	31	raise	raise	VERB
ihlr-18810	571	32	new	new	ADJ
ihlr-18810	571	33	issues	issue	NOUN
ihlr-18810	571	34	of	of	ADP
ihlr-18810	571	35	their	their	PRON
ihlr-18810	571	36	own	own	ADJ
ihlr-18810	571	37	.	.	PUNCT
ihlr-18810	572	1	increasing	increase	VERB
ihlr-18810	572	2	the	the	DET
ihlr-18810	572	3	post	post	ADJ
ihlr-18810	572	4	-	-	ADJ
ihlr-18810	572	5	market	market	ADJ
ihlr-18810	572	6	surveillance	surveillance	NOUN
ihlr-18810	572	7	efforts	effort	NOUN
ihlr-18810	572	8	of	of	ADP
ihlr-18810	572	9	the	the	DET
ihlr-18810	572	10	fda	fda	PROPN
ihlr-18810	572	11	after	after	SCONJ
ihlr-18810	572	12	the	the	DET
ihlr-18810	572	13	devices	device	NOUN
ihlr-18810	572	14	have	have	AUX
ihlr-18810	572	15	reached	reach	VERB
ihlr-18810	572	16	the	the	DET
ihlr-18810	572	17	market	market	NOUN
ihlr-18810	572	18	will	will	AUX
ihlr-18810	572	19	similarly	similarly	ADV
ihlr-18810	572	20	raise	raise	VERB
ihlr-18810	572	21	its	its	PRON
ihlr-18810	572	22	own	own	ADJ
ihlr-18810	572	23	problems	problem	NOUN
ihlr-18810	572	24	.	.	PUNCT
ihlr-18810	573	1	until	until	SCONJ
ihlr-18810	573	2	the	the	DET
ihlr-18810	573	3	mdr	mdr	PROPN
ihlr-18810	573	4	databases	database	NOUN
ihlr-18810	573	5	can	can	AUX
ihlr-18810	573	6	be	be	AUX
ihlr-18810	573	7	improved	improve	VERB
ihlr-18810	573	8	,	,	PUNCT
ihlr-18810	573	9	increasing	increase	VERB
ihlr-18810	573	10	reporting	reporting	NOUN
ihlr-18810	573	11	efforts	effort	NOUN
ihlr-18810	573	12	and	and	CCONJ
ihlr-18810	573	13	the	the	DET
ihlr-18810	573	14	depth	depth	NOUN
ihlr-18810	573	15	of	of	ADP
ihlr-18810	573	16	analysis	analysis	NOUN
ihlr-18810	573	17	of	of	ADP
ihlr-18810	573	18	these	these	DET
ihlr-18810	573	19	reports	report	NOUN
ihlr-18810	573	20	will	will	AUX
ihlr-18810	573	21	only	only	ADV
ihlr-18810	573	22	be	be	AUX
ihlr-18810	573	23	a	a	DET
ihlr-18810	573	24	daunting	daunting	ADJ
ihlr-18810	573	25	task	task	NOUN
ihlr-18810	573	26	for	for	ADP
ihlr-18810	573	27	the	the	DET
ihlr-18810	573	28	fda	fda	PROPN
ihlr-18810	573	29	.	.	PUNCT
ihlr-18810	574	1	furthermore	furthermore	ADV
ihlr-18810	574	2	,	,	PUNCT
ihlr-18810	574	3	until	until	SCONJ
ihlr-18810	574	4	providers	provider	NOUN
ihlr-18810	574	5	are	be	AUX
ihlr-18810	574	6	better	well	ADV
ihlr-18810	574	7	trained	train	VERB
ihlr-18810	574	8	and	and	CCONJ
ihlr-18810	574	9	more	more	ADV
ihlr-18810	574	10	able	able	ADJ
ihlr-18810	574	11	to	to	PART
ihlr-18810	574	12	recognize	recognize	VERB
ihlr-18810	574	13	effects	effect	NOUN
ihlr-18810	574	14	caused	cause	VERB
ihlr-18810	574	15	by	by	ADP
ihlr-18810	574	16	medical	medical	ADJ
ihlr-18810	574	17	devices	device	NOUN
ihlr-18810	574	18	,	,	PUNCT
ihlr-18810	574	19	efforts	effort	NOUN
ihlr-18810	574	20	to	to	PART
ihlr-18810	574	21	increase	increase	VERB
ihlr-18810	574	22	reporting	reporting	NOUN
ihlr-18810	574	23	will	will	AUX
ihlr-18810	574	24	not	not	PART
ihlr-18810	574	25	be	be	AUX
ihlr-18810	574	26	effective	effective	ADJ
ihlr-18810	574	27	.	.	PUNCT
ihlr-18810	575	1	224	224	NUM
ihlr-18810	575	2	the	the	DET
ihlr-18810	575	3	voluntary	voluntary	ADJ
ihlr-18810	575	4	reporting	reporting	NOUN
ihlr-18810	575	5	of	of	ADP
ihlr-18810	575	6	information	information	NOUN
ihlr-18810	575	7	will	will	AUX
ihlr-18810	575	8	only	only	ADV
ihlr-18810	575	9	be	be	AUX
ihlr-18810	575	10	as	as	ADV
ihlr-18810	575	11	helpful	helpful	ADJ
ihlr-18810	575	12	as	as	ADP
ihlr-18810	575	13	the	the	DET
ihlr-18810	575	14	completeness	completeness	NOUN
ihlr-18810	575	15	of	of	ADP
ihlr-18810	575	16	the	the	DET
ihlr-18810	575	17	information	information	NOUN
ihlr-18810	575	18	reported	report	VERB
ihlr-18810	575	19	,	,	PUNCT
ihlr-18810	575	20	and	and	CCONJ
ihlr-18810	575	21	until	until	SCONJ
ihlr-18810	575	22	the	the	DET
ihlr-18810	575	23	databases	database	NOUN
ihlr-18810	575	24	can	can	AUX
ihlr-18810	575	25	be	be	AUX
ihlr-18810	575	26	integrated	integrate	VERB
ihlr-18810	575	27	,	,	PUNCT
ihlr-18810	575	28	enabling	enable	VERB
ihlr-18810	575	29	all	all	DET
ihlr-18810	575	30	relevant	relevant	ADJ
ihlr-18810	575	31	information	information	NOUN
ihlr-18810	575	32	about	about	ADP
ihlr-18810	575	33	a	a	DET
ihlr-18810	575	34	medical	medical	ADJ
ihlr-18810	575	35	device	device	NOUN
ihlr-18810	575	36	to	to	PART
ihlr-18810	575	37	be	be	AUX
ihlr-18810	575	38	made	make	VERB
ihlr-18810	575	39	available	available	ADJ
ihlr-18810	575	40	at	at	ADP
ihlr-18810	575	41	once	once	ADV
ihlr-18810	575	42	and	and	CCONJ
ihlr-18810	575	43	analyzed	analyze	VERB
ihlr-18810	575	44	together	together	ADV
ihlr-18810	575	45	,	,	PUNCT
ihlr-18810	575	46	the	the	DET
ihlr-18810	575	47	conclusions	conclusion	NOUN
ihlr-18810	575	48	that	that	PRON
ihlr-18810	575	49	can	can	AUX
ihlr-18810	575	50	be	be	AUX
ihlr-18810	575	51	drawn	draw	VERB
ihlr-18810	575	52	from	from	ADP
ihlr-18810	575	53	a	a	DET
ihlr-18810	575	54	device	device	NOUN
ihlr-18810	575	55	's	's	PART
ihlr-18810	575	56	post	post	ADJ
ihlr-18810	575	57	-	-	ADJ
ihlr-18810	575	58	market	market	ADJ
ihlr-18810	575	59	performance	performance	NOUN
ihlr-18810	575	60	will	will	AUX
ihlr-18810	575	61	be	be	AUX
ihlr-18810	575	62	limited	limit	VERB
ihlr-18810	575	63	.	.	PUNCT
ihlr-18810	576	1	the	the	DET
ihlr-18810	576	2	issues	issue	NOUN
ihlr-18810	576	3	with	with	ADP
ihlr-18810	576	4	the	the	DET
ihlr-18810	576	5	fda	fda	PROPN
ihlr-18810	576	6	's	's	PART
ihlr-18810	576	7	post	post	ADJ
ihlr-18810	576	8	-	-	ADJ
ihlr-18810	576	9	market	market	ADJ
ihlr-18810	576	10	surveillance	surveillance	NOUN
ihlr-18810	576	11	efforts	effort	NOUN
ihlr-18810	576	12	are	be	AUX
ihlr-18810	576	13	not	not	PART
ihlr-18810	576	14	unique	unique	ADJ
ihlr-18810	576	15	to	to	ADP
ihlr-18810	576	16	510(k	510(k	NUM
ihlr-18810	576	17	)	)	PUNCT
ihlr-18810	576	18	cleared	clear	VERB
ihlr-18810	576	19	devices	device	NOUN
ihlr-18810	576	20	.	.	PUNCT
ihlr-18810	577	1	in	in	ADP
ihlr-18810	577	2	the	the	DET
ihlr-18810	577	3	past	past	NOUN
ihlr-18810	577	4	decade	decade	NOUN
ihlr-18810	577	5	,	,	PUNCT
ihlr-18810	577	6	the	the	DET
ihlr-18810	577	7	fda	fda	PROPN
ihlr-18810	577	8	has	have	AUX
ihlr-18810	577	9	seen	see	VERB
ihlr-18810	577	10	an	an	DET
ihlr-18810	577	11	increase	increase	NOUN
ihlr-18810	577	12	in	in	ADP
ihlr-18810	577	13	the	the	DET
ihlr-18810	577	14	number	number	NOUN
ihlr-18810	577	15	of	of	ADP
ihlr-18810	577	16	recalls	recall	NOUN
ihlr-18810	577	17	of	of	ADP
ihlr-18810	577	18	medical	medical	ADJ
ihlr-18810	577	19	devices	device	NOUN
ihlr-18810	577	20	,	,	PUNCT
ihlr-18810	577	21	as	as	ADV
ihlr-18810	577	22	well	well	ADV
ihlr-18810	577	23	as	as	ADP
ihlr-18810	577	24	the	the	DET
ihlr-18810	577	25	number	number	NOUN
ihlr-18810	577	26	of	of	ADP
ihlr-18810	577	27	adverse	adverse	ADJ
ihlr-18810	577	28	event	event	NOUN
ihlr-18810	577	29	reports	report	NOUN
ihlr-18810	577	30	,	,	PUNCT
ihlr-18810	577	31	225	225	NUM
ihlr-18810	577	32	which	which	PRON
ihlr-18810	577	33	has	have	AUX
ihlr-18810	577	34	prompted	prompt	VERB
ihlr-18810	577	35	the	the	DET
ihlr-18810	577	36	analysis	analysis	NOUN
ihlr-18810	577	37	of	of	ADP
ihlr-18810	577	38	the	the	DET
ihlr-18810	577	39	sufficiency	sufficiency	NOUN
ihlr-18810	577	40	of	of	ADP
ihlr-18810	577	41	post	post	ADJ
ihlr-18810	577	42	-	-	ADJ
ihlr-18810	577	43	market	market	ADJ
ihlr-18810	577	44	surveillance	surveillance	NOUN
ihlr-18810	577	45	efforts	effort	NOUN
ihlr-18810	577	46	.	.	PUNCT
ihlr-18810	578	1	in	in	ADP
ihlr-18810	578	2	early	early	ADJ
ihlr-18810	578	3	2003	2003	NUM
ihlr-18810	578	4	,	,	PUNCT
ihlr-18810	578	5	cdrh	cdrh	NOUN
ihlr-18810	578	6	conducted	conduct	VERB
ihlr-18810	578	7	an	an	DET
ihlr-18810	578	8	internal	internal	ADJ
ihlr-18810	578	9	evaluation	evaluation	NOUN
ihlr-18810	578	10	of	of	ADP
ihlr-18810	578	11	postapproval	postapproval	PROPN
ihlr-18810	578	12	studies	study	NOUN
ihlr-18810	578	13	,	,	PUNCT
ihlr-18810	578	14	studies	study	NOUN
ihlr-18810	578	15	done	do	VERB
ihlr-18810	578	16	on	on	ADP
ihlr-18810	578	17	devices	device	NOUN
ihlr-18810	578	18	after	after	SCONJ
ihlr-18810	578	19	they	they	PRON
ihlr-18810	578	20	are	be	AUX
ihlr-18810	578	21	222	222	NUM
ihlr-18810	578	22	iom	iom	PROPN
ihlr-18810	578	23	report	report	NOUN
ihlr-18810	578	24	,	,	PUNCT
ihlr-18810	578	25	supra	supra	PROPN
ihlr-18810	578	26	note	note	NOUN
ihlr-18810	578	27	6	6	NUM
ihlr-18810	578	28	,	,	PUNCT
ihlr-18810	578	29	at	at	ADP
ihlr-18810	578	30	10	10	NUM
ihlr-18810	578	31	.	.	PUNCT
ihlr-18810	578	32	223	223	NUM
ihlr-18810	579	1	i	i	PRON
ihlr-18810	579	2	d.	d.	PROPN
ihlr-18810	579	3	at	at	ADP
ihlr-18810	579	4	11	11	NUM
ihlr-18810	579	5	-	-	SYM
ihlr-18810	579	6	13	13	NUM
ihlr-18810	579	7	.	.	PUNCT
ihlr-18810	580	1	224	224	NUM
ihlr-18810	580	2	see	see	VERB
ihlr-18810	580	3	medsun	medsun	ADJ
ihlr-18810	580	4	,	,	PUNCT
ihlr-18810	580	5	supra	supra	PROPN
ihlr-18810	580	6	note	note	PROPN
ihlr-18810	580	7	138	138	NUM
ihlr-18810	580	8	.	.	NOUN
ihlr-18810	581	1	225	225	NUM
ihlr-18810	581	2	daniel	daniel	PROPN
ihlr-18810	581	3	schultz	schultz	PROPN
ihlr-18810	581	4	,	,	PUNCT
ihlr-18810	581	5	medical	medical	ADJ
ihlr-18810	581	6	device	device	NOUN
ihlr-18810	581	7	safety	safety	NOUN
ihlr-18810	581	8	fda	fda	PROPN
ihlr-18810	581	9	's	's	PART
ihlr-18810	581	10	postmarket	postmarket	ADJ
ihlr-18810	581	11	transformation	transformation	NOUN
ihlr-18810	581	12	initiative	initiative	NOUN
ihlr-18810	581	13	,	,	PUNCT
ihlr-18810	581	14	62	62	NUM
ihlr-18810	581	15	food	food	NOUN
ihlr-18810	581	16	&	&	CCONJ
ihlr-18810	581	17	drug	drug	PROPN
ihlr-18810	581	18	l.j	l.j	PROPN
ihlr-18810	581	19	.	.	PROPN
ihlr-18810	581	20	593	593	NUM
ihlr-18810	581	21	,	,	PUNCT
ihlr-18810	581	22	593	593	NUM
ihlr-18810	581	23	(	(	PUNCT
ihlr-18810	581	24	2007	2007	NUM
ihlr-18810	581	25	)	)	PUNCT
ihlr-18810	581	26	.	.	PUNCT
ihlr-18810	582	1	2013	2013	NUM
ihlr-18810	582	2	155	155	NUM
ihlr-18810	582	3	indiana	indiana	PROPN
ihlr-18810	582	4	health	health	PROPN
ihlr-18810	582	5	law	law	PROPN
ihlr-18810	582	6	review	review	NOUN
ihlr-18810	582	7	approved	approve	VERB
ihlr-18810	582	8	for	for	ADP
ihlr-18810	582	9	marketing	marketing	NOUN
ihlr-18810	582	10	under	under	ADP
ihlr-18810	582	11	the	the	DET
ihlr-18810	582	12	pma	pma	NOUN
ihlr-18810	582	13	process	process	NOUN
ihlr-18810	582	14	,	,	PUNCT
ihlr-18810	582	15	and	and	CCONJ
ihlr-18810	582	16	found	find	VERB
ihlr-18810	582	17	that	that	SCONJ
ihlr-18810	582	18	this	this	DET
ihlr-18810	582	19	process	process	NOUN
ihlr-18810	582	20	overall	overall	ADV
ihlr-18810	582	21	did	do	AUX
ihlr-18810	582	22	not	not	PART
ihlr-18810	582	23	perform	perform	VERB
ihlr-18810	582	24	as	as	SCONJ
ihlr-18810	582	25	expected	expect	VERB
ihlr-18810	582	26	,	,	PUNCT
ihlr-18810	582	27	and	and	CCONJ
ihlr-18810	582	28	that	that	SCONJ
ihlr-18810	582	29	this	this	DET
ihlr-18810	582	30	post	post	ADJ
ihlr-18810	582	31	-	-	ADJ
ihlr-18810	582	32	market	market	ADJ
ihlr-18810	582	33	surveillance	surveillance	NOUN
ihlr-18810	582	34	tool	tool	NOUN
ihlr-18810	582	35	and	and	CCONJ
ihlr-18810	582	36	oversight	oversight	NOUN
ihlr-18810	582	37	both	both	PRON
ihlr-18810	582	38	needed	need	VERB
ihlr-18810	582	39	to	to	PART
ihlr-18810	582	40	be	be	AUX
ihlr-18810	582	41	improved	improve	VERB
ihlr-18810	582	42	.	.	PUNCT
ihlr-18810	583	1	226	226	NUM
ihlr-18810	583	2	congress	congress	PROPN
ihlr-18810	583	3	has	have	AUX
ihlr-18810	583	4	also	also	ADV
ihlr-18810	583	5	recognized	recognize	VERB
ihlr-18810	583	6	the	the	DET
ihlr-18810	583	7	issues	issue	NOUN
ihlr-18810	583	8	with	with	ADP
ihlr-18810	583	9	post	post	ADJ
ihlr-18810	583	10	-	-	ADJ
ihlr-18810	583	11	market	market	ADJ
ihlr-18810	583	12	surveillance	surveillance	NOUN
ihlr-18810	583	13	,	,	PUNCT
ihlr-18810	583	14	and	and	CCONJ
ihlr-18810	583	15	in	in	ADP
ihlr-18810	583	16	2002	2002	NUM
ihlr-18810	583	17	directed	direct	VERB
ihlr-18810	583	18	227	227	NUM
ihlr-18810	583	19	the	the	DET
ihlr-18810	583	20	secretary	secretary	NOUN
ihlr-18810	583	21	of	of	ADP
ihlr-18810	583	22	hhs	hhs	PROPN
ihlr-18810	583	23	to	to	PART
ihlr-18810	583	24	study	study	VERB
ihlr-18810	583	25	the	the	DET
ihlr-18810	583	26	effects	effect	NOUN
ihlr-18810	583	27	of	of	ADP
ihlr-18810	583	28	the	the	DET
ihlr-18810	583	29	medical	medical	ADJ
ihlr-18810	583	30	device	device	NOUN
ihlr-18810	583	31	user	user	NOUN
ihlr-18810	583	32	fee	fee	NOUN
ihlr-18810	583	33	program	program	NOUN
ihlr-18810	583	34	on	on	ADP
ihlr-18810	583	35	post	post	ADJ
ihlr-18810	583	36	-	-	ADJ
ihlr-18810	583	37	market	market	ADJ
ihlr-18810	583	38	surveillance	surveillance	NOUN
ihlr-18810	583	39	,	,	PUNCT
ihlr-18810	583	40	and	and	CCONJ
ihlr-18810	583	41	instruct	instruct	VERB
ihlr-18810	583	42	the	the	DET
ihlr-18810	583	43	institute	institute	NOUN
ihlr-18810	583	44	of	of	ADP
ihlr-18810	583	45	medicine	medicine	PROPN
ihlr-18810	583	46	(	(	PUNCT
ihlr-18810	583	47	iom	iom	PROPN
ihlr-18810	583	48	)	)	PUNCT
ihlr-18810	583	49	to	to	PART
ihlr-18810	583	50	study	study	VERB
ihlr-18810	583	51	whether	whether	SCONJ
ihlr-18810	583	52	the	the	DET
ihlr-18810	583	53	post	post	ADJ
ihlr-18810	583	54	-	-	ADJ
ihlr-18810	583	55	market	market	ADJ
ihlr-18810	583	56	surveillance	surveillance	NOUN
ihlr-18810	583	57	system	system	NOUN
ihlr-18810	583	58	of	of	ADP
ihlr-18810	583	59	medical	medical	ADJ
ihlr-18810	583	60	devices	device	NOUN
ihlr-18810	583	61	provides	provide	VERB
ihlr-18810	583	62	adequate	adequate	ADJ
ihlr-18810	583	63	safeguards	safeguard	NOUN
ihlr-18810	583	64	regarding	regard	VERB
ihlr-18810	583	65	the	the	DET
ihlr-18810	583	66	use	use	NOUN
ihlr-18810	583	67	of	of	ADP
ihlr-18810	583	68	devices	device	NOUN
ihlr-18810	583	69	in	in	ADP
ihlr-18810	583	70	pediatric	pediatric	ADJ
ihlr-18810	583	71	patients	patient	NOUN
ihlr-18810	583	72	.	.	PUNCT
ihlr-18810	584	1	228	228	NUM
ihlr-18810	584	2	in	in	ADP
ihlr-18810	584	3	the	the	DET
ihlr-18810	584	4	iom	iom	PROPN
ihlr-18810	584	5	's	's	PART
ihlr-18810	584	6	resulting	result	VERB
ihlr-18810	584	7	report	report	NOUN
ihlr-18810	584	8	,	,	PUNCT
ihlr-18810	584	9	general	general	ADJ
ihlr-18810	584	10	shortfalls	shortfall	NOUN
ihlr-18810	584	11	in	in	ADP
ihlr-18810	584	12	the	the	DET
ihlr-18810	584	13	fda	fda	PROPN
ihlr-18810	584	14	's	's	PART
ihlr-18810	584	15	entire	entire	ADJ
ihlr-18810	584	16	postmarket	postmarket	ADJ
ihlr-18810	584	17	surveillance	surveillance	NOUN
ihlr-18810	584	18	process	process	NOUN
ihlr-18810	584	19	were	be	AUX
ihlr-18810	584	20	recognized	recognize	VERB
ihlr-18810	584	21	.	.	PUNCT
ihlr-18810	585	1	229	229	NUM
ihlr-18810	586	1	the	the	DET
ihlr-18810	586	2	iom	iom	PROPN
ihlr-18810	586	3	identified	identify	VERB
ihlr-18810	586	4	"	"	PUNCT
ihlr-18810	586	5	[	[	X
ihlr-18810	586	6	t]he	t]he	ADV
ihlr-18810	586	7	most	most	ADV
ihlr-18810	586	8	obvious	obvious	ADJ
ihlr-18810	586	9	deficits	deficit	NOUN
ihlr-18810	586	10	in	in	ADP
ihlr-18810	586	11	fda	fda	PROPN
ihlr-18810	586	12	's	's	PART
ihlr-18810	586	13	performance	performance	NOUN
ihlr-18810	586	14	are	be	AUX
ihlr-18810	586	15	the	the	DET
ihlr-18810	586	16	agency	agency	NOUN
ihlr-18810	586	17	's	's	PART
ihlr-18810	586	18	lack	lack	NOUN
ihlr-18810	586	19	of	of	ADP
ihlr-18810	586	20	effective	effective	ADJ
ihlr-18810	586	21	procedures	procedure	NOUN
ihlr-18810	586	22	for	for	ADP
ihlr-18810	586	23	monitoring	monitor	VERB
ihlr-18810	586	24	the	the	DET
ihlr-18810	586	25	status	status	NOUN
ihlr-18810	586	26	of	of	ADP
ihlr-18810	586	27	required	require	VERB
ihlr-18810	586	28	post	post	ADJ
ihlr-18810	586	29	-	-	ADJ
ihlr-18810	586	30	market	market	ADJ
ihlr-18810	586	31	studies	study	NOUN
ihlr-18810	586	32	and	and	CCONJ
ihlr-18810	586	33	the	the	DET
ihlr-18810	586	34	lack	lack	NOUN
ihlr-18810	586	35	of	of	ADP
ihlr-18810	586	36	public	public	ADJ
ihlr-18810	586	37	information	information	NOUN
ihlr-18810	586	38	regarding	regard	VERB
ihlr-18810	586	39	such	such	ADJ
ihlr-18810	586	40	studies	study	NOUN
ihlr-18810	586	41	.	.	PUNCT
ihlr-18810	587	1	"230	"230	PROPN
ihlr-18810	587	2	furthermore	furthermore	ADV
ihlr-18810	587	3	,	,	PUNCT
ihlr-18810	587	4	the	the	DET
ihlr-18810	587	5	fda	fda	PROPN
ihlr-18810	587	6	's	's	PART
ihlr-18810	587	7	authority	authority	NOUN
ihlr-18810	587	8	to	to	PART
ihlr-18810	587	9	order	order	VERB
ihlr-18810	587	10	post	post	ADJ
ihlr-18810	587	11	-	-	ADJ
ihlr-18810	587	12	market	market	ADJ
ihlr-18810	587	13	studies	study	NOUN
ihlr-18810	587	14	is	be	AUX
ihlr-18810	587	15	limited	limited	ADJ
ihlr-18810	587	16	.	.	PUNCT
ihlr-18810	588	1	studies	study	NOUN
ihlr-18810	588	2	can	can	AUX
ihlr-18810	588	3	not	not	PART
ihlr-18810	588	4	be	be	AUX
ihlr-18810	588	5	required	require	VERB
ihlr-18810	588	6	as	as	ADP
ihlr-18810	588	7	a	a	DET
ihlr-18810	588	8	condition	condition	NOUN
ihlr-18810	588	9	of	of	ADP
ihlr-18810	588	10	approving	approve	VERB
ihlr-18810	588	11	devices	device	NOUN
ihlr-18810	588	12	through	through	ADP
ihlr-18810	588	13	the	the	DET
ihlr-18810	588	14	pma	pma	NOUN
ihlr-18810	588	15	process	process	NOUN
ihlr-18810	588	16	,	,	PUNCT
ihlr-18810	588	17	and	and	CCONJ
ihlr-18810	588	18	for	for	ADP
ihlr-18810	588	19	devices	device	NOUN
ihlr-18810	588	20	already	already	ADV
ihlr-18810	588	21	granted	grant	VERB
ihlr-18810	588	22	pma	pma	NOUN
ihlr-18810	588	23	approval	approval	NOUN
ihlr-18810	588	24	;	;	PUNCT
ihlr-18810	588	25	the	the	DET
ihlr-18810	588	26	fda	fda	PROPN
ihlr-18810	588	27	can	can	AUX
ihlr-18810	588	28	not	not	PART
ihlr-18810	588	29	require	require	VERB
ihlr-18810	588	30	postmarket	postmarket	ADJ
ihlr-18810	588	31	studies	study	NOUN
ihlr-18810	588	32	that	that	PRON
ihlr-18810	588	33	will	will	AUX
ihlr-18810	588	34	last	last	VERB
ihlr-18810	588	35	more	more	ADJ
ihlr-18810	588	36	than	than	ADP
ihlr-18810	588	37	three	three	NUM
ihlr-18810	588	38	years.231	years.231	PROPN
ihlr-18810	588	39	b.	b.	PROPN
ihlr-18810	588	40	use	use	NOUN
ihlr-18810	588	41	of	of	ADP
ihlr-18810	588	42	comparative	comparative	ADJ
ihlr-18810	588	43	effectiveness	effectiveness	NOUN
ihlr-18810	588	44	research	research	NOUN
ihlr-18810	588	45	by	by	ADP
ihlr-18810	588	46	the	the	DET
ihlr-18810	588	47	government	government	NOUN
ihlr-18810	588	48	as	as	ADP
ihlr-18810	588	49	payer	payer	NOUN
ihlr-18810	588	50	the	the	DET
ihlr-18810	588	51	limits	limit	NOUN
ihlr-18810	588	52	which	which	PRON
ihlr-18810	588	53	constrain	constrain	VERB
ihlr-18810	588	54	the	the	DET
ihlr-18810	588	55	fda	fda	PROPN
ihlr-18810	588	56	's	's	PART
ihlr-18810	588	57	regulatory	regulatory	ADJ
ihlr-18810	588	58	226	226	NUM
ihlr-18810	588	59	danica	danica	PROPN
ihlr-18810	588	60	marinac	marinac	ADJ
ihlr-18810	588	61	-	-	PUNCT
ihlr-18810	588	62	dabic	dabic	NOUN
ihlr-18810	588	63	et	et	PROPN
ihlr-18810	588	64	al	al	PROPN
ihlr-18810	588	65	.	.	PROPN
ihlr-18810	588	66	,	,	PUNCT
ihlr-18810	588	67	medical	medical	ADJ
ihlr-18810	588	68	devices	device	NOUN
ihlr-18810	588	69	post	post	ADJ
ihlr-18810	588	70	-	-	ADJ
ihlr-18810	588	71	approval	approval	ADJ
ihlr-18810	588	72	studies	study	NOUN
ihlr-18810	588	73	program	program	NOUN
ihlr-18810	588	74	:	:	PUNCT
ihlr-18810	588	75	vision	vision	NOUN
ihlr-18810	588	76	,	,	PUNCT
ihlr-18810	588	77	strategies	strategy	NOUN
ihlr-18810	588	78	,	,	PUNCT
ihlr-18810	588	79	challenges	challenge	NOUN
ihlr-18810	588	80	and	and	CCONJ
ihlr-18810	588	81	opportunities	opportunity	NOUN
ihlr-18810	588	82	,	,	PUNCT
ihlr-18810	588	83	62	62	NUM
ihlr-18810	588	84	food	food	NOUN
ihlr-18810	588	85	&	&	CCONJ
ihlr-18810	588	86	drug	drug	PROPN
ihlr-18810	588	87	l.j	l.j	PROPN
ihlr-18810	588	88	.	.	PROPN
ihlr-18810	588	89	597	597	NUM
ihlr-18810	588	90	,	,	PUNCT
ihlr-18810	588	91	598	598	NUM
ihlr-18810	588	92	-	-	SYM
ihlr-18810	588	93	99	99	NUM
ihlr-18810	588	94	(	(	PUNCT
ihlr-18810	588	95	2007	2007	NUM
ihlr-18810	588	96	)	)	PUNCT
ihlr-18810	588	97	.	.	PUNCT
ihlr-18810	589	1	227	227	NUM
ihlr-18810	589	2	medical	medical	ADJ
ihlr-18810	589	3	device	device	NOUN
ihlr-18810	589	4	user	user	NOUN
ihlr-18810	589	5	fee	fee	NOUN
ihlr-18810	589	6	and	and	CCONJ
ihlr-18810	589	7	modernization	modernization	NOUN
ihlr-18810	589	8	act	act	NOUN
ihlr-18810	589	9	of	of	ADP
ihlr-18810	589	10	2002	2002	NUM
ihlr-18810	589	11	,	,	PUNCT
ihlr-18810	589	12	pub	pub	NOUN
ihlr-18810	589	13	.	.	PUNCT
ihlr-18810	590	1	l.	l.	PROPN
ihlr-18810	590	2	no	no	INTJ
ihlr-18810	590	3	.	.	PUNCT
ihlr-18810	591	1	107	107	NUM
ihlr-18810	591	2	-	-	SYM
ihlr-18810	591	3	250	250	NUM
ihlr-18810	591	4	1071h	1071h	NUM
ihlr-18810	591	5	cong	cong	NOUN
ihlr-18810	591	6	.	.	PUNCT
ihlr-18810	592	1	(	(	PUNCT
ihlr-18810	592	2	2002	2002	NUM
ihlr-18810	592	3	)	)	PUNCT
ihlr-18810	592	4	,	,	PUNCT
ihlr-18810	592	5	available	available	ADJ
ihlr-18810	592	6	at	at	ADP
ihlr-18810	592	7	http://www.fda.gov/	http://www.fda.gov/	PROPN
ihlr-18810	592	8	regulatoryinformation	regulatoryinformation	NOUN
ihlr-18810	592	9	/	/	SYM
ihlr-18810	592	10	legislation	legislation	NOUN
ihlr-18810	592	11	/	/	SYM
ihlr-18810	592	12	federalfooddrugandcosmeticactfdcact/	federalfooddrugandcosmeticactfdcact/	NUM
ihlr-18810	592	13	significantamendmentstothefdcact	significantamendmentstothefdcact	NOUN
ihlr-18810	592	14	/	/	SYM
ihlr-18810	592	15	medicaldeviceuserfeeandmodernizati	medicaldeviceuserfeeandmodernizati	NOUN
ihlr-18810	592	16	onactmdufmaof2002	onactmdufmaof2002	PROPN
ihlr-18810	592	17	/	/	SYM
ihlr-18810	593	1	default.htm	default.htm	X
ihlr-18810	593	2	.	.	PUNCT
ihlr-18810	594	1	228	228	NUM
ihlr-18810	594	2	marinac	marinac	ADJ
ihlr-18810	594	3	-	-	PUNCT
ihlr-18810	594	4	dabic	dabic	ADJ
ihlr-18810	594	5	,	,	PUNCT
ihlr-18810	594	6	supra	supra	PROPN
ihlr-18810	594	7	note	note	PROPN
ihlr-18810	594	8	226	226	NUM
ihlr-18810	594	9	,	,	PUNCT
ihlr-18810	594	10	at	at	ADP
ihlr-18810	594	11	598	598	NUM
ihlr-18810	594	12	-	-	SYM
ihlr-18810	594	13	99	99	NUM
ihlr-18810	594	14	.	.	PUNCT
ihlr-18810	594	15	229	229	NUM
ihlr-18810	594	16	inst	inst	NOUN
ihlr-18810	594	17	.	.	PROPN
ihlr-18810	594	18	of	of	ADP
ihlr-18810	594	19	med	med	PROPN
ihlr-18810	594	20	.	.	PROPN
ihlr-18810	594	21	,	,	PUNCT
ihlr-18810	594	22	safe	safe	ADJ
ihlr-18810	594	23	medical	medical	ADJ
ihlr-18810	594	24	devices	device	NOUN
ihlr-18810	594	25	for	for	ADP
ihlr-18810	594	26	children	child	NOUN
ihlr-18810	594	27	5	5	NUM
ihlr-18810	594	28	(	(	PUNCT
ihlr-18810	594	29	marilyn	marilyn	PROPN
ihlr-18810	594	30	j.	j.	PROPN
ihlr-18810	594	31	field	field	PROPN
ihlr-18810	594	32	&	&	CCONJ
ihlr-18810	594	33	hugh	hugh	PROPN
ihlr-18810	594	34	tilson	tilson	PROPN
ihlr-18810	594	35	eds	eds	PROPN
ihlr-18810	594	36	.	.	PROPN
ihlr-18810	594	37	,	,	PUNCT
ihlr-18810	594	38	2005	2005	NUM
ihlr-18810	594	39	)	)	PUNCT
ihlr-18810	594	40	,	,	PUNCT
ihlr-18810	594	41	available	available	ADJ
ihlr-18810	594	42	at	at	ADP
ihlr-18810	594	43	http://books.nap.edul	http://books.nap.edul	PROPN
ihlr-18810	594	44	openbook.php?recordid=11313&page=rl	openbook.php?recordid=11313&page=rl	PROPN
ihlr-18810	594	45	.	.	PROPN
ihlr-18810	594	46	230	230	NUM
ihlr-18810	595	1	i	i	PROPN
ihlr-18810	595	2	d.	d.	PROPN
ihlr-18810	595	3	at	at	ADP
ihlr-18810	595	4	6	6	NUM
ihlr-18810	595	5	.	.	SYM
ihlr-18810	595	6	231	231	NUM
ihlr-18810	595	7	i	i	PRON
ihlr-18810	595	8	d.	d.	PROPN
ihlr-18810	595	9	at	at	ADP
ihlr-18810	595	10	7	7	NUM
ihlr-18810	595	11	.	.	NOUN
ihlr-18810	595	12	156	156	NUM
ihlr-18810	595	13	vol	vol	NOUN
ihlr-18810	595	14	.	.	PUNCT
ihlr-18810	596	1	10:1	10:1	NUM
ihlr-18810	596	2	510(k	510(k	NUM
ihlr-18810	596	3	)	)	PUNCT
ihlr-18810	596	4	clearance	clearance	NOUN
ihlr-18810	596	5	activities	activity	NOUN
ihlr-18810	596	6	are	be	AUX
ihlr-18810	596	7	caused	cause	VERB
ihlr-18810	596	8	primarily	primarily	ADV
ihlr-18810	596	9	by	by	ADP
ihlr-18810	596	10	the	the	DET
ihlr-18810	596	11	limited	limited	ADJ
ihlr-18810	596	12	resources	resource	NOUN
ihlr-18810	596	13	and	and	CCONJ
ihlr-18810	596	14	funding	funding	NOUN
ihlr-18810	596	15	available	available	ADJ
ihlr-18810	596	16	to	to	ADP
ihlr-18810	596	17	the	the	DET
ihlr-18810	596	18	fda	fda	PROPN
ihlr-18810	596	19	to	to	PART
ihlr-18810	596	20	carry	carry	VERB
ihlr-18810	596	21	out	out	ADP
ihlr-18810	596	22	its	its	PRON
ihlr-18810	596	23	activities	activity	NOUN
ihlr-18810	596	24	.	.	PUNCT
ihlr-18810	597	1	although	although	SCONJ
ihlr-18810	597	2	the	the	DET
ihlr-18810	597	3	fda	fda	PROPN
ihlr-18810	597	4	is	be	AUX
ihlr-18810	597	5	certainly	certainly	ADV
ihlr-18810	597	6	making	make	VERB
ihlr-18810	597	7	an	an	DET
ihlr-18810	597	8	effort	effort	NOUN
ihlr-18810	597	9	to	to	PART
ihlr-18810	597	10	work	work	VERB
ihlr-18810	597	11	effectively	effectively	ADV
ihlr-18810	597	12	even	even	ADV
ihlr-18810	597	13	within	within	ADP
ihlr-18810	597	14	these	these	DET
ihlr-18810	597	15	constraints	constraint	NOUN
ihlr-18810	597	16	,	,	PUNCT
ihlr-18810	597	17	the	the	DET
ihlr-18810	597	18	effects	effect	NOUN
ihlr-18810	597	19	are	be	AUX
ihlr-18810	597	20	evident	evident	ADJ
ihlr-18810	597	21	not	not	PART
ihlr-18810	597	22	merely	merely	ADV
ihlr-18810	597	23	in	in	ADP
ihlr-18810	597	24	the	the	DET
ihlr-18810	597	25	outcomes	outcome	NOUN
ihlr-18810	597	26	achieved	achieve	VERB
ihlr-18810	597	27	by	by	ADP
ihlr-18810	597	28	the	the	DET
ihlr-18810	597	29	fda	fda	PROPN
ihlr-18810	597	30	,	,	PUNCT
ihlr-18810	597	31	but	but	CCONJ
ihlr-18810	597	32	also	also	ADV
ihlr-18810	597	33	in	in	ADP
ihlr-18810	597	34	the	the	DET
ihlr-18810	597	35	performance	performance	NOUN
ihlr-18810	597	36	goals	goal	NOUN
ihlr-18810	597	37	it	it	PRON
ihlr-18810	597	38	sets	set	VERB
ihlr-18810	597	39	for	for	ADP
ihlr-18810	597	40	itself	itself	PRON
ihlr-18810	597	41	.	.	PUNCT
ihlr-18810	598	1	for	for	ADP
ihlr-18810	598	2	example	example	NOUN
ihlr-18810	598	3	,	,	PUNCT
ihlr-18810	598	4	in	in	ADP
ihlr-18810	598	5	2008	2008	NUM
ihlr-18810	598	6	the	the	DET
ihlr-18810	598	7	fda	fda	PROPN
ihlr-18810	598	8	set	set	VERB
ihlr-18810	598	9	a	a	DET
ihlr-18810	598	10	performance	performance	NOUN
ihlr-18810	598	11	goal	goal	NOUN
ihlr-18810	598	12	to	to	PART
ihlr-18810	598	13	review	review	VERB
ihlr-18810	598	14	60	60	NUM
ihlr-18810	598	15	%	%	NOUN
ihlr-18810	598	16	of	of	ADP
ihlr-18810	598	17	original	original	ADJ
ihlr-18810	598	18	pma	pma	NOUN
ihlr-18810	598	19	applications	application	NOUN
ihlr-18810	598	20	in	in	ADP
ihlr-18810	598	21	180	180	NUM
ihlr-18810	598	22	days	day	NOUN
ihlr-18810	598	23	and	and	CCONJ
ihlr-18810	598	24	90	90	NUM
ihlr-18810	598	25	%	%	NOUN
ihlr-18810	598	26	in	in	ADP
ihlr-18810	598	27	295	295	NUM
ihlr-18810	598	28	days	day	NOUN
ihlr-18810	598	29	.	.	PUNCT
ihlr-18810	599	1	2	2	NUM
ihlr-18810	599	2	32	32	NUM
ihlr-18810	599	3	this	this	DET
ihlr-18810	599	4	goal	goal	NOUN
ihlr-18810	599	5	was	be	AUX
ihlr-18810	599	6	not	not	PART
ihlr-18810	599	7	met	meet	VERB
ihlr-18810	599	8	in	in	ADP
ihlr-18810	599	9	2008	2008	NUM
ihlr-18810	599	10	,	,	PUNCT
ihlr-18810	599	11	but	but	CCONJ
ihlr-18810	599	12	was	be	AUX
ihlr-18810	599	13	exceeded	exceed	VERB
ihlr-18810	599	14	in	in	ADP
ihlr-18810	599	15	2009	2009	NUM
ihlr-18810	599	16	.	.	PUNCT
ihlr-18810	600	1	however	however	ADV
ihlr-18810	600	2	,	,	PUNCT
ihlr-18810	600	3	in	in	ADP
ihlr-18810	600	4	recent	recent	ADJ
ihlr-18810	600	5	years	year	NOUN
ihlr-18810	600	6	,	,	PUNCT
ihlr-18810	600	7	the	the	DET
ihlr-18810	600	8	fda	fda	PROPN
ihlr-18810	600	9	decreased	decrease	VERB
ihlr-18810	600	10	its	its	PRON
ihlr-18810	600	11	performance	performance	NOUN
ihlr-18810	600	12	goal.2	goal.2	PROPN
ihlr-18810	600	13	33	33	NUM
ihlr-18810	600	14	the	the	DET
ihlr-18810	600	15	2012	2012	NUM
ihlr-18810	600	16	bud	bud	NOUN
ihlr-18810	600	17	-	-	PUNCT
ihlr-18810	600	18	get	get	NOUN
ihlr-18810	600	19	report	report	NOUN
ihlr-18810	600	20	predicted	predict	VERB
ihlr-18810	600	21	"	"	PUNCT
ihlr-18810	600	22	[	[	X
ihlr-18810	600	23	ilf	ilf	X
ihlr-18810	600	24	the	the	DET
ihlr-18810	600	25	number	number	NOUN
ihlr-18810	600	26	of	of	ADP
ihlr-18810	600	27	reviewers	reviewer	NOUN
ihlr-18810	600	28	remains	remain	VERB
ihlr-18810	600	29	constant	constant	ADJ
ihlr-18810	600	30	,	,	PUNCT
ihlr-18810	600	31	cdrh	cdrh	NOUN
ihlr-18810	600	32	expects	expect	VERB
ihlr-18810	600	33	performance	performance	NOUN
ihlr-18810	600	34	levels	level	NOUN
ihlr-18810	600	35	to	to	PART
ihlr-18810	600	36	decrease	decrease	VERB
ihlr-18810	600	37	due	due	ADP
ihlr-18810	600	38	to	to	ADP
ihlr-18810	600	39	the	the	DET
ihlr-18810	600	40	increasing	increase	VERB
ihlr-18810	600	41	complexity	complexity	NOUN
ihlr-18810	600	42	of	of	ADP
ihlr-18810	600	43	pmas	pma	NOUN
ihlr-18810	600	44	.	.	PUNCT
ihlr-18810	600	45	"	"	PUNCT
ihlr-18810	601	1	23	23	NUM
ihlr-18810	601	2	4	4	NUM
ihlr-18810	601	3	the	the	DET
ihlr-18810	601	4	goals	goal	NOUN
ihlr-18810	601	5	for	for	ADP
ihlr-18810	601	6	review	review	NOUN
ihlr-18810	601	7	of	of	ADP
ihlr-18810	601	8	510(k	510(k	PROPN
ihlr-18810	601	9	)	)	PUNCT
ihlr-18810	601	10	applications	application	NOUN
ihlr-18810	601	11	have	have	AUX
ihlr-18810	601	12	similarly	similarly	ADV
ihlr-18810	601	13	been	be	AUX
ihlr-18810	601	14	lowered	lower	VERB
ihlr-18810	601	15	in	in	ADP
ihlr-18810	601	16	recent	recent	ADJ
ihlr-18810	601	17	years	year	NOUN
ihlr-18810	601	18	,	,	PUNCT
ihlr-18810	601	19	from	from	ADP
ihlr-18810	601	20	90	90	NUM
ihlr-18810	601	21	%	%	NOUN
ihlr-18810	601	22	in	in	ADP
ihlr-18810	601	23	ninety	ninety	NUM
ihlr-18810	601	24	days	day	NOUN
ihlr-18810	601	25	and	and	CCONJ
ihlr-18810	601	26	98	98	NUM
ihlr-18810	601	27	%	%	NOUN
ihlr-18810	601	28	in	in	ADP
ihlr-18810	601	29	150	150	NUM
ihlr-18810	601	30	days	day	NOUN
ihlr-18810	601	31	in	in	ADP
ihlr-18810	601	32	2010	2010	NUM
ihlr-18810	601	33	to	to	ADP
ihlr-18810	601	34	75	75	NUM
ihlr-18810	601	35	%	%	NOUN
ihlr-18810	601	36	in	in	ADP
ihlr-18810	601	37	ninety	ninety	NUM
ihlr-18810	601	38	days	day	NOUN
ihlr-18810	601	39	and	and	CCONJ
ihlr-18810	601	40	80	80	NUM
ihlr-18810	601	41	%	%	NOUN
ihlr-18810	601	42	in	in	ADP
ihlr-18810	601	43	150	150	NUM
ihlr-18810	601	44	days	day	NOUN
ihlr-18810	601	45	for	for	ADP
ihlr-18810	601	46	2012.235	2012.235	NUM
ihlr-18810	601	47	the	the	DET
ihlr-18810	601	48	fda	fda	PROPN
ihlr-18810	601	49	explained	explain	VERB
ihlr-18810	601	50	,	,	PUNCT
ihlr-18810	601	51	"	"	PUNCT
ihlr-18810	601	52	[	[	X
ihlr-18810	601	53	ilf	ilf	X
ihlr-18810	601	54	the	the	DET
ihlr-18810	601	55	number	number	NOUN
ihlr-18810	601	56	of	of	ADP
ihlr-18810	601	57	reviewers	reviewer	NOUN
ihlr-18810	601	58	remains	remain	VERB
ihlr-18810	601	59	constant	constant	ADJ
ihlr-18810	601	60	,	,	PUNCT
ihlr-18810	601	61	cdrh	cdrh	NOUN
ihlr-18810	601	62	expects	expect	VERB
ihlr-18810	601	63	performance	performance	NOUN
ihlr-18810	601	64	levels	level	NOUN
ihlr-18810	601	65	to	to	PART
ihlr-18810	601	66	decrease	decrease	VERB
ihlr-18810	601	67	.	.	PUNCT
ihlr-18810	602	1	"236	"236	PROPN
ihlr-18810	602	2	on	on	ADP
ihlr-18810	602	3	the	the	DET
ihlr-18810	602	4	plus	plus	ADJ
ihlr-18810	602	5	side	side	NOUN
ihlr-18810	602	6	,	,	PUNCT
ihlr-18810	602	7	the	the	DET
ihlr-18810	602	8	fda	fda	PROPN
ihlr-18810	602	9	's	's	PART
ihlr-18810	602	10	goals	goal	NOUN
ihlr-18810	602	11	for	for	ADP
ihlr-18810	602	12	the	the	DET
ihlr-18810	602	13	number	number	NOUN
ihlr-18810	602	14	of	of	ADP
ihlr-18810	602	15	class	class	NOUN
ihlr-18810	602	16	ii	ii	PROPN
ihlr-18810	602	17	and	and	CCONJ
ihlr-18810	602	18	class	class	NOUN
ihlr-18810	602	19	iii	iii	NOUN
ihlr-18810	602	20	device	device	NOUN
ihlr-18810	602	21	inspections	inspection	NOUN
ihlr-18810	602	22	,	,	PUNCT
ihlr-18810	602	23	both	both	CCONJ
ihlr-18810	602	24	domestic	domestic	ADJ
ihlr-18810	602	25	and	and	CCONJ
ihlr-18810	602	26	foreign	foreign	ADJ
ihlr-18810	602	27	,	,	PUNCT
ihlr-18810	602	28	have	have	AUX
ihlr-18810	602	29	been	be	AUX
ihlr-18810	602	30	increasing	increase	VERB
ihlr-18810	602	31	each	each	DET
ihlr-18810	602	32	year	year	NOUN
ihlr-18810	602	33	since	since	SCONJ
ihlr-18810	602	34	2008	2008	NUM
ihlr-18810	602	35	,	,	PUNCT
ihlr-18810	602	36	and	and	CCONJ
ihlr-18810	602	37	have	have	AUX
ihlr-18810	602	38	been	be	AUX
ihlr-18810	602	39	exceeded	exceed	VERB
ihlr-18810	602	40	each	each	DET
ihlr-18810	602	41	year	year	NOUN
ihlr-18810	602	42	for	for	ADP
ihlr-18810	602	43	which	which	PRON
ihlr-18810	602	44	information	information	NOUN
ihlr-18810	602	45	is	be	AUX
ihlr-18810	602	46	available.237	available.237	ADJ
ihlr-18810	602	47	to	to	PART
ihlr-18810	602	48	improve	improve	VERB
ihlr-18810	602	49	the	the	DET
ihlr-18810	602	50	fda	fda	PROPN
ihlr-18810	602	51	's	's	PART
ihlr-18810	602	52	ability	ability	NOUN
ihlr-18810	602	53	to	to	PART
ihlr-18810	602	54	adequately	adequately	ADV
ihlr-18810	602	55	exercise	exercise	VERB
ihlr-18810	602	56	its	its	PRON
ihlr-18810	602	57	authority	authority	NOUN
ihlr-18810	602	58	and	and	CCONJ
ihlr-18810	602	59	ensure	ensure	VERB
ihlr-18810	602	60	the	the	DET
ihlr-18810	602	61	safety	safety	NOUN
ihlr-18810	602	62	of	of	ADP
ihlr-18810	602	63	the	the	DET
ihlr-18810	602	64	products	product	NOUN
ihlr-18810	602	65	it	it	PRON
ihlr-18810	602	66	regulates	regulate	VERB
ihlr-18810	602	67	,	,	PUNCT
ihlr-18810	602	68	a	a	DET
ihlr-18810	602	69	budget	budget	NOUN
ihlr-18810	602	70	increase	increase	NOUN
ihlr-18810	602	71	would	would	AUX
ihlr-18810	602	72	go	go	VERB
ihlr-18810	602	73	a	a	DET
ihlr-18810	602	74	long	long	ADJ
ihlr-18810	602	75	way	way	NOUN
ihlr-18810	602	76	in	in	ADP
ihlr-18810	602	77	alleviating	alleviate	VERB
ihlr-18810	602	78	the	the	DET
ihlr-18810	602	79	burdens	burden	NOUN
ihlr-18810	602	80	the	the	DET
ihlr-18810	602	81	agency	agency	NOUN
ihlr-18810	602	82	already	already	ADV
ihlr-18810	602	83	experiences	experience	VERB
ihlr-18810	602	84	through	through	ADP
ihlr-18810	602	85	its	its	PRON
ihlr-18810	602	86	limited	limited	ADJ
ihlr-18810	602	87	re	re	NOUN
ihlr-18810	602	88	-	-	NOUN
ihlr-18810	602	89	sources	source	NOUN
ihlr-18810	602	90	and	and	CCONJ
ihlr-18810	602	91	manpower	manpower	NOUN
ihlr-18810	602	92	.	.	PUNCT
ihlr-18810	603	1	consequently	consequently	ADV
ihlr-18810	603	2	,	,	PUNCT
ihlr-18810	603	3	the	the	DET
ihlr-18810	603	4	fda	fda	PROPN
ihlr-18810	603	5	is	be	AUX
ihlr-18810	603	6	232	232	NUM
ihlr-18810	603	7	dep't	dep't	NOUN
ihlr-18810	603	8	health	health	PROPN
ihlr-18810	603	9	&	&	CCONJ
ihlr-18810	603	10	human	human	PROPN
ihlr-18810	603	11	servs	servs	PROPN
ihlr-18810	603	12	.	.	PUNCT
ihlr-18810	603	13	,	,	PUNCT
ihlr-18810	603	14	food	food	PROPN
ihlr-18810	603	15	&	&	CCONJ
ihlr-18810	603	16	drug	drug	PROPN
ihlr-18810	603	17	administration	administration	PROPN
ihlr-18810	603	18	:	:	PUNCT
ihlr-18810	603	19	fy	fy	PROPN
ihlr-18810	603	20	2012	2012	NUM
ihlr-18810	603	21	online	online	ADJ
ihlr-18810	603	22	performance	performance	NOUN
ihlr-18810	603	23	appendix	appendix	NOUN
ihlr-18810	603	24	42	42	NUM
ihlr-18810	603	25	(	(	PUNCT
ihlr-18810	603	26	2012	2012	NUM
ihlr-18810	603	27	)	)	PUNCT
ihlr-18810	603	28	,	,	PUNCT
ihlr-18810	603	29	available	available	ADJ
ihlr-18810	603	30	at	at	ADP
ihlr-18810	603	31	http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/	http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/	PROPN
ihlr-18810	603	32	reports	report	NOUN
ihlr-18810	603	33	/	/	SYM
ihlr-18810	603	34	budgetreports	budgetreport	NOUN
ihlr-18810	603	35	/	/	SYM
ihlr-18810	603	36	ucm242730.pdf	ucm242730.pdf	NOUN
ihlr-18810	603	37	.	.	PUNCT
ihlr-18810	604	1	233	233	NUM
ihlr-18810	605	1	i	i	PRON
ihlr-18810	605	2	d.	d.	PROPN
ihlr-18810	605	3	at	at	ADP
ihlr-18810	605	4	42	42	NUM
ihlr-18810	605	5	(	(	PUNCT
ihlr-18810	605	6	decreasing	decrease	VERB
ihlr-18810	605	7	the	the	DET
ihlr-18810	605	8	performance	performance	NOUN
ihlr-18810	605	9	goal	goal	NOUN
ihlr-18810	605	10	to	to	ADP
ihlr-18810	605	11	50	50	NUM
ihlr-18810	605	12	%	%	NOUN
ihlr-18810	605	13	in	in	ADP
ihlr-18810	605	14	180	180	NUM
ihlr-18810	605	15	days	day	NOUN
ihlr-18810	605	16	and	and	CCONJ
ihlr-18810	605	17	70	70	NUM
ihlr-18810	605	18	%	%	NOUN
ihlr-18810	605	19	in	in	ADP
ihlr-18810	605	20	295	295	NUM
ihlr-18810	605	21	days	day	NOUN
ihlr-18810	605	22	in	in	ADP
ihlr-18810	605	23	2011	2011	NUM
ihlr-18810	605	24	,	,	PUNCT
ihlr-18810	605	25	and	and	CCONJ
ihlr-18810	605	26	50	50	NUM
ihlr-18810	605	27	%	%	NOUN
ihlr-18810	605	28	in	in	ADP
ihlr-18810	605	29	180	180	NUM
ihlr-18810	605	30	days	day	NOUN
ihlr-18810	605	31	and	and	CCONJ
ihlr-18810	605	32	60	60	NUM
ihlr-18810	605	33	%	%	NOUN
ihlr-18810	605	34	in	in	ADP
ihlr-18810	605	35	295	295	NUM
ihlr-18810	605	36	days	day	NOUN
ihlr-18810	605	37	for	for	ADP
ihlr-18810	605	38	2012	2012	NUM
ihlr-18810	605	39	)	)	PUNCT
ihlr-18810	605	40	.	.	PUNCT
ihlr-18810	606	1	234	234	NUM
ihlr-18810	607	1	i	i	PRON
ihlr-18810	607	2	d.	d.	PROPN
ihlr-18810	607	3	at	at	ADP
ihlr-18810	607	4	47	47	NUM
ihlr-18810	607	5	.	.	PUNCT
ihlr-18810	607	6	235	235	NUM
ihlr-18810	608	1	i	i	PRON
ihlr-18810	608	2	d.	d.	PROPN
ihlr-18810	608	3	at	at	ADP
ihlr-18810	608	4	42	42	NUM
ihlr-18810	608	5	.	.	PUNCT
ihlr-18810	608	6	236	236	NUM
ihlr-18810	609	1	i	i	PRON
ihlr-18810	609	2	d.	d.	PROPN
ihlr-18810	609	3	at	at	ADP
ihlr-18810	609	4	47	47	NUM
ihlr-18810	609	5	.	.	PUNCT
ihlr-18810	609	6	237	237	NUM
ihlr-18810	610	1	i	i	PRON
ihlr-18810	610	2	d.	d.	PROPN
ihlr-18810	610	3	at	at	ADP
ihlr-18810	610	4	44	44	NUM
ihlr-18810	610	5	.	.	PUNCT
ihlr-18810	611	1	in	in	ADP
ihlr-18810	611	2	2008	2008	NUM
ihlr-18810	611	3	,	,	PUNCT
ihlr-18810	611	4	the	the	DET
ihlr-18810	611	5	goal	goal	NOUN
ihlr-18810	611	6	of	of	ADP
ihlr-18810	611	7	1,270	1,270	NUM
ihlr-18810	611	8	inspections	inspection	NOUN
ihlr-18810	611	9	was	be	AUX
ihlr-18810	611	10	exceeded	exceed	VERB
ihlr-18810	611	11	with	with	ADP
ihlr-18810	611	12	a	a	DET
ihlr-18810	611	13	total	total	NOUN
ihlr-18810	611	14	of	of	ADP
ihlr-18810	611	15	1,431	1,431	NUM
ihlr-18810	611	16	inspections	inspection	NOUN
ihlr-18810	611	17	that	that	DET
ihlr-18810	611	18	year	year	NOUN
ihlr-18810	611	19	.	.	PUNCT
ihlr-18810	612	1	the	the	DET
ihlr-18810	612	2	goals	goal	NOUN
ihlr-18810	612	3	have	have	AUX
ihlr-18810	612	4	been	be	AUX
ihlr-18810	612	5	increased	increase	VERB
ihlr-18810	612	6	to	to	ADP
ihlr-18810	612	7	1,365	1,365	NUM
ihlr-18810	612	8	in	in	ADP
ihlr-18810	612	9	2012	2012	NUM
ihlr-18810	612	10	(	(	PUNCT
ihlr-18810	612	11	exceeded	exceed	VERB
ihlr-18810	612	12	with	with	ADP
ihlr-18810	612	13	1,659	1,659	NUM
ihlr-18810	612	14	inspections	inspection	NOUN
ihlr-18810	612	15	that	that	DET
ihlr-18810	612	16	year	year	NOUN
ihlr-18810	612	17	)	)	PUNCT
ihlr-18810	612	18	,	,	PUNCT
ihlr-18810	612	19	and	and	CCONJ
ihlr-18810	612	20	1,515	1,515	NUM
ihlr-18810	612	21	for	for	ADP
ihlr-18810	612	22	2012	2012	NUM
ihlr-18810	612	23	.	.	PUNCT
ihlr-18810	613	1	2013	2013	NUM
ihlr-18810	613	2	157	157	NUM
ihlr-18810	613	3	indiana	indiana	PROPN
ihlr-18810	613	4	health	health	PROPN
ihlr-18810	613	5	law	law	PROPN
ihlr-18810	613	6	review	review	NOUN
ihlr-18810	613	7	requesting	request	VERB
ihlr-18810	613	8	a	a	DET
ihlr-18810	613	9	17	17	NUM
ihlr-18810	613	10	%	%	NOUN
ihlr-18810	613	11	increase	increase	NOUN
ihlr-18810	613	12	in	in	ADP
ihlr-18810	613	13	its	its	PRON
ihlr-18810	613	14	budget	budget	NOUN
ihlr-18810	613	15	as	as	ADP
ihlr-18810	613	16	part	part	NOUN
ihlr-18810	613	17	of	of	ADP
ihlr-18810	613	18	president	president	PROPN
ihlr-18810	613	19	obama	obama	PROPN
ihlr-18810	613	20	's	's	PART
ihlr-18810	613	21	fiscal	fiscal	ADJ
ihlr-18810	613	22	year	year	NOUN
ihlr-18810	613	23	2013	2013	NUM
ihlr-18810	613	24	budget.238	budget.238	ADP
ihlr-18810	613	25	the	the	DET
ihlr-18810	613	26	majority	majority	NOUN
ihlr-18810	613	27	of	of	ADP
ihlr-18810	613	28	this	this	DET
ihlr-18810	613	29	increase	increase	NOUN
ihlr-18810	613	30	would	would	AUX
ihlr-18810	613	31	,	,	PUNCT
ihlr-18810	613	32	under	under	ADP
ihlr-18810	613	33	the	the	DET
ihlr-18810	613	34	proposal	proposal	NOUN
ihlr-18810	613	35	,	,	PUNCT
ihlr-18810	613	36	come	come	VERB
ihlr-18810	613	37	from	from	ADP
ihlr-18810	613	38	industry	industry	NOUN
ihlr-18810	613	39	user	user	NOUN
ihlr-18810	613	40	fees	fee	NOUN
ihlr-18810	613	41	(	(	PUNCT
ihlr-18810	613	42	such	such	ADJ
ihlr-18810	613	43	as	as	ADP
ihlr-18810	613	44	application	application	NOUN
ihlr-18810	613	45	and	and	CCONJ
ihlr-18810	613	46	inspection	inspection	NOUN
ihlr-18810	613	47	fees	fee	NOUN
ihlr-18810	613	48	)	)	PUNCT
ihlr-18810	613	49	,	,	PUNCT
ihlr-18810	613	50	which	which	PRON
ihlr-18810	613	51	would	would	AUX
ihlr-18810	613	52	account	account	VERB
ihlr-18810	613	53	for	for	ADP
ihlr-18810	613	54	98	98	NUM
ihlr-18810	613	55	%	%	NOUN
ihlr-18810	613	56	of	of	ADP
ihlr-18810	613	57	this	this	DET
ihlr-18810	613	58	increase	increase	NOUN
ihlr-18810	613	59	.	.	PUNCT
ihlr-18810	614	1	239	239	NUM
ihlr-18810	614	2	in	in	ADP
ihlr-18810	614	3	previous	previous	ADJ
ihlr-18810	614	4	years	year	NOUN
ihlr-18810	614	5	,	,	PUNCT
ihlr-18810	614	6	about	about	ADV
ihlr-18810	614	7	one	one	NUM
ihlr-18810	614	8	third	third	NOUN
ihlr-18810	614	9	of	of	ADP
ihlr-18810	614	10	the	the	DET
ihlr-18810	614	11	fda	fda	PROPN
ihlr-18810	614	12	's	's	PART
ihlr-18810	614	13	budget	budget	NOUN
ihlr-18810	614	14	was	be	AUX
ihlr-18810	614	15	funded	fund	VERB
ihlr-18810	614	16	through	through	ADP
ihlr-18810	614	17	user	user	NOUN
ihlr-18810	614	18	fees	fee	NOUN
ihlr-18810	614	19	;	;	PUNCT
ihlr-18810	614	20	under	under	ADP
ihlr-18810	614	21	the	the	DET
ihlr-18810	614	22	new	new	ADJ
ihlr-18810	614	23	proposal	proposal	NOUN
ihlr-18810	614	24	,	,	PUNCT
ihlr-18810	614	25	however	however	ADV
ihlr-18810	614	26	,	,	PUNCT
ihlr-18810	614	27	this	this	DET
ihlr-18810	614	28	amount	amount	NOUN
ihlr-18810	614	29	would	would	AUX
ihlr-18810	614	30	be	be	AUX
ihlr-18810	614	31	increased	increase	VERB
ihlr-18810	614	32	to	to	ADP
ihlr-18810	614	33	45%.240	45%.240	NUM
ihlr-18810	614	34	federal	federal	ADJ
ihlr-18810	614	35	spending	spending	NOUN
ihlr-18810	614	36	on	on	ADP
ihlr-18810	614	37	the	the	DET
ihlr-18810	614	38	fda	fda	PROPN
ihlr-18810	614	39	would	would	AUX
ihlr-18810	614	40	be	be	AUX
ihlr-18810	614	41	increased	increase	VERB
ihlr-18810	614	42	by	by	ADP
ihlr-18810	614	43	only	only	ADV
ihlr-18810	614	44	0.5%.241	0.5%.241	NUM
ihlr-18810	614	45	this	this	DET
ihlr-18810	614	46	new	new	ADJ
ihlr-18810	614	47	budget	budget	NOUN
ihlr-18810	614	48	plan	plan	NOUN
ihlr-18810	614	49	would	would	AUX
ihlr-18810	614	50	bring	bring	VERB
ihlr-18810	614	51	the	the	DET
ihlr-18810	614	52	fda	fda	PROPN
ihlr-18810	614	53	's	's	PART
ihlr-18810	614	54	total	total	ADJ
ihlr-18810	614	55	budget	budget	NOUN
ihlr-18810	614	56	to	to	ADP
ihlr-18810	614	57	$	$	SYM
ihlr-18810	614	58	4.5	4.5	NUM
ihlr-18810	614	59	billion.242	billion.242	NOUN
ihlr-18810	614	60	however	however	ADV
ihlr-18810	614	61	,	,	PUNCT
ihlr-18810	614	62	the	the	DET
ihlr-18810	614	63	fda	fda	PROPN
ihlr-18810	614	64	does	do	AUX
ihlr-18810	614	65	not	not	PART
ihlr-18810	614	66	yet	yet	ADV
ihlr-18810	614	67	have	have	VERB
ihlr-18810	614	68	cause	cause	VERB
ihlr-18810	614	69	to	to	PART
ihlr-18810	614	70	celebrate	celebrate	VERB
ihlr-18810	614	71	;	;	PUNCT
ihlr-18810	614	72	obama	obama	PROPN
ihlr-18810	614	73	's	's	PART
ihlr-18810	614	74	proposed	propose	VERB
ihlr-18810	614	75	budget	budget	NOUN
ihlr-18810	614	76	plan	plan	NOUN
ihlr-18810	614	77	must	must	AUX
ihlr-18810	614	78	be	be	AUX
ihlr-18810	614	79	approved	approve	VERB
ihlr-18810	614	80	by	by	ADP
ihlr-18810	614	81	congress	congress	PROPN
ihlr-18810	614	82	before	before	SCONJ
ihlr-18810	614	83	it	it	PRON
ihlr-18810	614	84	can	can	AUX
ihlr-18810	614	85	be	be	AUX
ihlr-18810	614	86	effective	effective	ADJ
ihlr-18810	614	87	.	.	PUNCT
ihlr-18810	615	1	debates	debate	NOUN
ihlr-18810	615	2	over	over	ADP
ihlr-18810	615	3	spending	spending	NOUN
ihlr-18810	615	4	cuts	cut	NOUN
ihlr-18810	615	5	,	,	PUNCT
ihlr-18810	615	6	tax	tax	NOUN
ihlr-18810	615	7	hikes	hike	NOUN
ihlr-18810	615	8	,	,	PUNCT
ihlr-18810	615	9	and	and	CCONJ
ihlr-18810	615	10	resource	resource	NOUN
ihlr-18810	615	11	allocation	allocation	NOUN
ihlr-18810	615	12	could	could	AUX
ihlr-18810	615	13	easily	easily	ADV
ihlr-18810	615	14	stall	stall	VERB
ihlr-18810	615	15	this	this	DET
ihlr-18810	615	16	budget	budget	NOUN
ihlr-18810	615	17	plan	plan	NOUN
ihlr-18810	615	18	before	before	SCONJ
ihlr-18810	615	19	the	the	DET
ihlr-18810	615	20	fda	fda	PROPN
ihlr-18810	615	21	gets	get	VERB
ihlr-18810	615	22	a	a	DET
ihlr-18810	615	23	chance	chance	NOUN
ihlr-18810	615	24	to	to	PART
ihlr-18810	615	25	benefit	benefit	VERB
ihlr-18810	615	26	from	from	ADP
ihlr-18810	615	27	any	any	PRON
ihlr-18810	615	28	of	of	ADP
ihlr-18810	615	29	the	the	DET
ihlr-18810	615	30	proposed	propose	VERB
ihlr-18810	615	31	measures	measure	NOUN
ihlr-18810	615	32	.	.	PUNCT
ihlr-18810	616	1	243	243	NUM
ihlr-18810	616	2	one	one	NUM
ihlr-18810	616	3	important	important	ADJ
ihlr-18810	616	4	way	way	NOUN
ihlr-18810	616	5	the	the	DET
ihlr-18810	616	6	safety	safety	NOUN
ihlr-18810	616	7	and	and	CCONJ
ihlr-18810	616	8	efficacy	efficacy	NOUN
ihlr-18810	616	9	of	of	ADP
ihlr-18810	616	10	devices	device	NOUN
ihlr-18810	616	11	can	can	AUX
ihlr-18810	616	12	be	be	AUX
ihlr-18810	616	13	ensured	ensure	VERB
ihlr-18810	616	14	without	without	ADP
ihlr-18810	616	15	increasing	increase	VERB
ihlr-18810	616	16	the	the	DET
ihlr-18810	616	17	burdens	burden	NOUN
ihlr-18810	616	18	on	on	ADP
ihlr-18810	616	19	an	an	DET
ihlr-18810	616	20	already	already	ADV
ihlr-18810	616	21	overwhelmed	overwhelmed	ADJ
ihlr-18810	616	22	fda	fda	PROPN
ihlr-18810	616	23	is	be	AUX
ihlr-18810	616	24	through	through	ADP
ihlr-18810	616	25	assigning	assign	VERB
ihlr-18810	616	26	to	to	ADP
ihlr-18810	616	27	another	another	DET
ihlr-18810	616	28	agency	agency	NOUN
ihlr-18810	616	29	or	or	CCONJ
ihlr-18810	616	30	department	department	NOUN
ihlr-18810	616	31	the	the	DET
ihlr-18810	616	32	task	task	NOUN
ihlr-18810	616	33	of	of	ADP
ihlr-18810	616	34	increasing	increase	VERB
ihlr-18810	616	35	the	the	DET
ihlr-18810	616	36	study	study	NOUN
ihlr-18810	616	37	and	and	CCONJ
ihlr-18810	616	38	surveillance	surveillance	NOUN
ihlr-18810	616	39	of	of	ADP
ihlr-18810	616	40	medical	medical	ADJ
ihlr-18810	616	41	devices	device	NOUN
ihlr-18810	616	42	.	.	PUNCT
ihlr-18810	617	1	this	this	PRON
ihlr-18810	617	2	can	can	AUX
ihlr-18810	617	3	be	be	AUX
ihlr-18810	617	4	done	do	VERB
ihlr-18810	617	5	postmarket	postmarket	NOUN
ihlr-18810	617	6	,	,	PUNCT
ihlr-18810	617	7	and	and	CCONJ
ihlr-18810	617	8	therefore	therefore	ADV
ihlr-18810	617	9	would	would	AUX
ihlr-18810	617	10	not	not	PART
ihlr-18810	617	11	infringe	infringe	VERB
ihlr-18810	617	12	on	on	ADP
ihlr-18810	617	13	the	the	DET
ihlr-18810	617	14	fda	fda	PROPN
ihlr-18810	617	15	's	's	PART
ihlr-18810	617	16	authority	authority	NOUN
ihlr-18810	617	17	,	,	PUNCT
ihlr-18810	617	18	but	but	CCONJ
ihlr-18810	617	19	instead	instead	ADV
ihlr-18810	617	20	would	would	AUX
ihlr-18810	617	21	complement	complement	VERB
ihlr-18810	617	22	the	the	DET
ihlr-18810	617	23	fda	fda	PROPN
ihlr-18810	617	24	's	's	PART
ihlr-18810	617	25	postmarket	postmarket	ADJ
ihlr-18810	617	26	surveillance	surveillance	NOUN
ihlr-18810	617	27	efforts	effort	NOUN
ihlr-18810	617	28	.	.	PUNCT
ihlr-18810	618	1	consumers	consumer	NOUN
ihlr-18810	618	2	and	and	CCONJ
ihlr-18810	618	3	payers	payer	NOUN
ihlr-18810	618	4	can	can	AUX
ihlr-18810	618	5	also	also	ADV
ihlr-18810	618	6	have	have	VERB
ihlr-18810	618	7	an	an	DET
ihlr-18810	618	8	impact	impact	NOUN
ihlr-18810	618	9	on	on	ADP
ihlr-18810	618	10	the	the	DET
ihlr-18810	618	11	safety	safety	NOUN
ihlr-18810	618	12	and	and	CCONJ
ihlr-18810	618	13	efficacy	efficacy	NOUN
ihlr-18810	618	14	of	of	ADP
ihlr-18810	618	15	products	product	NOUN
ihlr-18810	618	16	available	available	ADJ
ihlr-18810	618	17	on	on	ADP
ihlr-18810	618	18	the	the	DET
ihlr-18810	618	19	market	market	NOUN
ihlr-18810	618	20	.	.	PUNCT
ihlr-18810	619	1	this	this	PRON
ihlr-18810	619	2	can	can	AUX
ihlr-18810	619	3	be	be	AUX
ihlr-18810	619	4	done	do	VERB
ihlr-18810	619	5	through	through	ADP
ihlr-18810	619	6	the	the	DET
ihlr-18810	619	7	use	use	NOUN
ihlr-18810	619	8	of	of	ADP
ihlr-18810	619	9	comparative	comparative	ADJ
ihlr-18810	619	10	effectiveness	effectiveness	NOUN
ihlr-18810	619	11	research	research	NOUN
ihlr-18810	619	12	(	(	PUNCT
ihlr-18810	619	13	cer	cer	NOUN
ihlr-18810	619	14	)	)	PUNCT
ihlr-18810	619	15	in	in	ADP
ihlr-18810	619	16	payer	payer	NOUN
ihlr-18810	619	17	decisions	decision	NOUN
ihlr-18810	619	18	to	to	PART
ihlr-18810	619	19	cover	cover	VERB
ihlr-18810	619	20	available	available	ADJ
ihlr-18810	619	21	devices	device	NOUN
ihlr-18810	619	22	,	,	PUNCT
ihlr-18810	619	23	and	and	CCONJ
ihlr-18810	619	24	can	can	AUX
ihlr-18810	619	25	have	have	VERB
ihlr-18810	619	26	the	the	DET
ihlr-18810	619	27	most	most	ADJ
ihlr-18810	619	28	238	238	NUM
ihlr-18810	619	29	fda	fda	PROPN
ihlr-18810	619	30	news	news	NOUN
ihlr-18810	619	31	release	release	NOUN
ihlr-18810	619	32	.	.	PUNCT
ihlr-18810	620	1	fda	fda	PROPN
ihlr-18810	620	2	seeks	seek	VERB
ihlr-18810	620	3	$	$	SYM
ihlr-18810	620	4	4.5	4.5	NUM
ihlr-18810	620	5	billion	billion	NUM
ihlr-18810	620	6	to	to	PART
ihlr-18810	620	7	support	support	VERB
ihlr-18810	620	8	medical	medical	ADJ
ihlr-18810	620	9	product	product	NOUN
ihlr-18810	620	10	development	development	NOUN
ihlr-18810	620	11	,	,	PUNCT
ihlr-18810	620	12	protect	protect	VERB
ihlr-18810	620	13	patients	patient	NOUN
ihlr-18810	620	14	and	and	CCONJ
ihlr-18810	620	15	ensure	ensure	VERB
ihlr-18810	620	16	safety	safety	NOUN
ihlr-18810	620	17	of	of	ADP
ihlr-18810	620	18	the	the	DET
ihlr-18810	620	19	food	food	NOUN
ihlr-18810	620	20	supply	supply	NOUN
ihlr-18810	620	21	,	,	PUNCT
ihlr-18810	620	22	fda.gov	fda.gov	NUM
ihlr-18810	620	23	(	(	PUNCT
ihlr-18810	620	24	feb	feb	PROPN
ihlr-18810	620	25	13	13	NUM
ihlr-18810	620	26	,	,	PUNCT
ihlr-18810	620	27	2012	2012	NUM
ihlr-18810	620	28	)	)	PUNCT
ihlr-18810	620	29	,	,	PUNCT
ihlr-18810	620	30	http://www.fda.gov/newsevents/	http://www.fda.gov/newsevents/	PROPN
ihlr-18810	620	31	newsroom	newsroom	NOUN
ihlr-18810	620	32	/	/	SYM
ihlr-18810	620	33	pressannouncements	pressannouncement	NOUN
ihlr-18810	620	34	/	/	SYM
ihlr-18810	620	35	ucm291691.htm	ucm291691.htm	PROPN
ihlr-18810	621	1	[	[	X
ihlr-18810	621	2	hereinafter	hereinafter	NOUN
ihlr-18810	621	3	fda	fda	PROPN
ihlr-18810	621	4	news	news	PROPN
ihlr-18810	621	5	release	release	PROPN
ihlr-18810	621	6	]	]	PUNCT
ihlr-18810	621	7	(	(	PUNCT
ihlr-18810	621	8	covering	cover	VERB
ihlr-18810	621	9	the	the	DET
ihlr-18810	621	10	period	period	NOUN
ihlr-18810	621	11	from	from	ADP
ihlr-18810	621	12	oct	oct	PROPN
ihlr-18810	621	13	.	.	PROPN
ihlr-18810	621	14	1	1	NUM
ihlr-18810	621	15	,	,	PUNCT
ihlr-18810	621	16	2012	2012	NUM
ihlr-18810	621	17	through	through	ADP
ihlr-18810	621	18	sept	sept	PROPN
ihlr-18810	621	19	30	30	NUM
ihlr-18810	621	20	,	,	PUNCT
ihlr-18810	621	21	2013	2013	NUM
ihlr-18810	621	22	)	)	PUNCT
ihlr-18810	621	23	.	.	PUNCT
ihlr-18810	622	1	239	239	NUM
ihlr-18810	622	2	i	i	NOUN
ihlr-18810	622	3	d	d	PROPN
ihlr-18810	622	4	240	240	NUM
ihlr-18810	622	5	anna	anna	PROPN
ihlr-18810	622	6	yukhananov	yukhananov	PROPN
ihlr-18810	622	7	,	,	PUNCT
ihlr-18810	622	8	obama	obama	PROPN
ihlr-18810	622	9	asks	ask	VERB
ihlr-18810	622	10	for	for	ADP
ihlr-18810	622	11	hike	hike	NOUN
ihlr-18810	622	12	in	in	ADP
ihlr-18810	622	13	industry	industry	NOUN
ihlr-18810	622	14	funding	funding	NOUN
ihlr-18810	622	15	for	for	ADP
ihlr-18810	622	16	fda	fda	PROPN
ihlr-18810	622	17	,	,	PUNCT
ihlr-18810	622	18	reuters	reuters	PROPN
ihlr-18810	622	19	,	,	PUNCT
ihlr-18810	622	20	(	(	PUNCT
ihlr-18810	622	21	feb	feb	PROPN
ihlr-18810	622	22	.	.	PROPN
ihlr-18810	622	23	13	13	NUM
ihlr-18810	622	24	,	,	PUNCT
ihlr-18810	622	25	2012	2012	NUM
ihlr-18810	622	26	)	)	PUNCT
ihlr-18810	622	27	,	,	PUNCT
ihlr-18810	622	28	http://www.reuters.com/article/2012/	http://www.reuters.com/article/2012/	PROPN
ihlr-18810	622	29	02/13	02/13	ADJ
ihlr-18810	622	30	/	/	SYM
ihlr-18810	622	31	us	us	PROPN
ihlr-18810	622	32	-	-	PUNCT
ihlr-18810	622	33	budget	budget	NOUN
ihlr-18810	622	34	-	-	PUNCT
ihlr-18810	622	35	fda	fda	PROPN
ihlr-18810	622	36	-	-	PUNCT
ihlr-18810	622	37	idustre81c24020120213	idustre81c24020120213	PROPN
ihlr-18810	622	38	.	.	PROPN
ihlr-18810	622	39	241	241	NUM
ihlr-18810	623	1	i	i	PRON
ihlr-18810	623	2	d.	d.	PROPN
ihlr-18810	623	3	total	total	PROPN
ihlr-18810	623	4	federal	federal	ADJ
ihlr-18810	623	5	spending	spending	NOUN
ihlr-18810	623	6	on	on	ADP
ihlr-18810	623	7	the	the	DET
ihlr-18810	623	8	fda	fda	PROPN
ihlr-18810	623	9	under	under	ADP
ihlr-18810	623	10	this	this	DET
ihlr-18810	623	11	proposed	propose	VERB
ihlr-18810	623	12	budget	budget	NOUN
ihlr-18810	623	13	would	would	AUX
ihlr-18810	623	14	be	be	AUX
ihlr-18810	623	15	$	$	SYM
ihlr-18810	623	16	2.5	2.5	NUM
ihlr-18810	623	17	billion	billion	NUM
ihlr-18810	623	18	for	for	ADP
ihlr-18810	623	19	fy	fy	PROPN
ihlr-18810	623	20	2013	2013	NUM
ihlr-18810	623	21	.	.	PUNCT
ihlr-18810	624	1	242	242	NUM
ihlr-18810	624	2	fda	fda	PROPN
ihlr-18810	624	3	news	news	PROPN
ihlr-18810	624	4	release	release	NOUN
ihlr-18810	624	5	,	,	PUNCT
ihlr-18810	624	6	supra	supra	PROPN
ihlr-18810	624	7	note	note	NOUN
ihlr-18810	624	8	238	238	NUM
ihlr-18810	624	9	.	.	PUNCT
ihlr-18810	625	1	243	243	NUM
ihlr-18810	625	2	yukhananov	yukhananov	NOUN
ihlr-18810	625	3	,	,	PUNCT
ihlr-18810	625	4	supra	supra	PROPN
ihlr-18810	625	5	note	note	NOUN
ihlr-18810	625	6	240	240	NUM
ihlr-18810	625	7	.	.	NOUN
ihlr-18810	625	8	158	158	NUM
ihlr-18810	625	9	vol	vol	NOUN
ihlr-18810	625	10	.	.	PUNCT
ihlr-18810	626	1	10:1	10:1	NUM
ihlr-18810	626	2	510(k	510(k	X
ihlr-18810	626	3	)	)	PUNCT
ihlr-18810	626	4	clearance	clearance	NOUN
ihlr-18810	626	5	impact	impact	NOUN
ihlr-18810	626	6	on	on	ADP
ihlr-18810	626	7	the	the	DET
ihlr-18810	626	8	device	device	NOUN
ihlr-18810	626	9	market	market	NOUN
ihlr-18810	626	10	if	if	SCONJ
ihlr-18810	626	11	the	the	DET
ihlr-18810	626	12	largest	large	ADJ
ihlr-18810	626	13	payer	payer	NOUN
ihlr-18810	626	14	is	be	AUX
ihlr-18810	626	15	able	able	ADJ
ihlr-18810	626	16	to	to	PART
ihlr-18810	626	17	make	make	VERB
ihlr-18810	626	18	use	use	NOUN
ihlr-18810	626	19	of	of	ADP
ihlr-18810	626	20	comparative	comparative	ADJ
ihlr-18810	626	21	effectiveness	effectiveness	NOUN
ihlr-18810	626	22	research	research	NOUN
ihlr-18810	626	23	in	in	ADP
ihlr-18810	626	24	their	their	PRON
ihlr-18810	626	25	coverage	coverage	NOUN
ihlr-18810	626	26	deter	deter	NOUN
ihlr-18810	626	27	-	-	PUNCT
ihlr-18810	626	28	minations	mination	NOUN
ihlr-18810	626	29	:	:	PUNCT
ihlr-18810	626	30	the	the	DET
ihlr-18810	626	31	government	government	NOUN
ihlr-18810	626	32	.	.	PUNCT
ihlr-18810	627	1	the	the	PRON
ihlr-18810	627	2	u.s	u.s	PROPN
ihlr-18810	627	3	.	.	PROPN
ihlr-18810	627	4	spends	spend	VERB
ihlr-18810	627	5	over	over	ADP
ihlr-18810	627	6	$	$	SYM
ihlr-18810	627	7	2	2	NUM
ihlr-18810	627	8	trillion	trillion	NUM
ihlr-18810	627	9	on	on	ADP
ihlr-18810	627	10	health	health	NOUN
ihlr-18810	627	11	annually.244	annually.244	NOUN
ihlr-18810	627	12	only	only	ADV
ihlr-18810	627	13	about	about	ADV
ihlr-18810	627	14	5	5	NUM
ihlr-18810	627	15	%	%	NOUN
ihlr-18810	627	16	of	of	ADP
ihlr-18810	627	17	the	the	DET
ihlr-18810	627	18	u.s	u.s	PROPN
ihlr-18810	627	19	.	.	PROPN
ihlr-18810	627	20	's	's	PART
ihlr-18810	627	21	overall	overall	ADJ
ihlr-18810	627	22	health	health	NOUN
ihlr-18810	627	23	expenditures	expenditure	NOUN
ihlr-18810	627	24	are	be	AUX
ihlr-18810	627	25	devoted	devote	VERB
ihlr-18810	627	26	to	to	ADP
ihlr-18810	627	27	research	research	NOUN
ihlr-18810	627	28	,	,	PUNCT
ihlr-18810	627	29	and	and	CCONJ
ihlr-18810	627	30	the	the	DET
ihlr-18810	627	31	vast	vast	ADJ
ihlr-18810	627	32	majority	majority	NOUN
ihlr-18810	627	33	of	of	ADP
ihlr-18810	627	34	this	this	PRON
ihlr-18810	627	35	goes	go	VERB
ihlr-18810	627	36	to	to	ADP
ihlr-18810	627	37	product	product	NOUN
ihlr-18810	627	38	development	development	NOUN
ihlr-18810	627	39	and	and	CCONJ
ihlr-18810	627	40	basic	basic	ADJ
ihlr-18810	627	41	research	research	NOUN
ihlr-18810	627	42	,	,	PUNCT
ihlr-18810	627	43	not	not	PART
ihlr-18810	627	44	into	into	ADP
ihlr-18810	627	45	assessing	assess	VERB
ihlr-18810	627	46	the	the	DET
ihlr-18810	627	47	effectiveness	effectiveness	NOUN
ihlr-18810	627	48	or	or	CCONJ
ihlr-18810	627	49	outcomes	outcome	NOUN
ihlr-18810	627	50	of	of	ADP
ihlr-18810	627	51	treatment	treatment	NOUN
ihlr-18810	627	52	options	option	NOUN
ihlr-18810	627	53	.	.	PUNCT
ihlr-18810	628	1	245	245	NUM
ihlr-18810	628	2	the	the	DET
ihlr-18810	628	3	first	first	ADJ
ihlr-18810	628	4	goal	goal	NOUN
ihlr-18810	628	5	,	,	PUNCT
ihlr-18810	628	6	therefore	therefore	ADV
ihlr-18810	628	7	,	,	PUNCT
ihlr-18810	628	8	should	should	AUX
ihlr-18810	628	9	be	be	AUX
ihlr-18810	628	10	to	to	PART
ihlr-18810	628	11	increase	increase	VERB
ihlr-18810	628	12	the	the	DET
ihlr-18810	628	13	amount	amount	NOUN
ihlr-18810	628	14	of	of	ADP
ihlr-18810	628	15	comparative	comparative	ADJ
ihlr-18810	628	16	effectiveness	effectiveness	NOUN
ihlr-18810	628	17	research	research	NOUN
ihlr-18810	628	18	being	be	AUX
ihlr-18810	628	19	conducted	conduct	VERB
ihlr-18810	628	20	.	.	PUNCT
ihlr-18810	629	1	once	once	SCONJ
ihlr-18810	629	2	helpful	helpful	ADJ
ihlr-18810	629	3	information	information	NOUN
ihlr-18810	629	4	has	have	AUX
ihlr-18810	629	5	been	be	AUX
ihlr-18810	629	6	gathered	gather	VERB
ihlr-18810	629	7	,	,	PUNCT
ihlr-18810	629	8	it	it	PRON
ihlr-18810	629	9	can	can	AUX
ihlr-18810	629	10	be	be	AUX
ihlr-18810	629	11	used	use	VERB
ihlr-18810	629	12	by	by	ADP
ihlr-18810	629	13	payers	payer	NOUN
ihlr-18810	629	14	to	to	PART
ihlr-18810	629	15	incentivize	incentivize	VERB
ihlr-18810	629	16	the	the	DET
ihlr-18810	629	17	use	use	NOUN
ihlr-18810	629	18	of	of	ADP
ihlr-18810	629	19	the	the	DET
ihlr-18810	629	20	most	most	ADV
ihlr-18810	629	21	safe	safe	ADJ
ihlr-18810	629	22	and	and	CCONJ
ihlr-18810	629	23	effective	effective	ADJ
ihlr-18810	629	24	devices	device	NOUN
ihlr-18810	629	25	available	available	ADJ
ihlr-18810	629	26	,	,	PUNCT
ihlr-18810	629	27	thereby	thereby	ADV
ihlr-18810	629	28	improving	improve	VERB
ihlr-18810	629	29	the	the	DET
ihlr-18810	629	30	care	care	NOUN
ihlr-18810	629	31	given	give	VERB
ihlr-18810	629	32	to	to	ADP
ihlr-18810	629	33	patients	patient	NOUN
ihlr-18810	629	34	and	and	CCONJ
ihlr-18810	629	35	helping	help	VERB
ihlr-18810	629	36	to	to	PART
ihlr-18810	629	37	keep	keep	VERB
ihlr-18810	629	38	unsafe	unsafe	ADJ
ihlr-18810	629	39	or	or	CCONJ
ihlr-18810	629	40	ineffective	ineffective	ADJ
ihlr-18810	629	41	devices	device	NOUN
ihlr-18810	629	42	cleared	clear	VERB
ihlr-18810	629	43	for	for	ADP
ihlr-18810	629	44	the	the	DET
ihlr-18810	629	45	market	market	NOUN
ihlr-18810	629	46	without	without	ADP
ihlr-18810	629	47	pre	pre	ADJ
ihlr-18810	629	48	-	-	ADJ
ihlr-18810	629	49	market	market	ADJ
ihlr-18810	629	50	analysis	analysis	NOUN
ihlr-18810	629	51	or	or	CCONJ
ihlr-18810	629	52	approval	approval	NOUN
ihlr-18810	629	53	from	from	ADP
ihlr-18810	629	54	being	be	AUX
ihlr-18810	629	55	used	use	VERB
ihlr-18810	629	56	in	in	ADP
ihlr-18810	629	57	common	common	ADJ
ihlr-18810	629	58	medical	medical	ADJ
ihlr-18810	629	59	practice	practice	NOUN
ihlr-18810	629	60	until	until	SCONJ
ihlr-18810	629	61	they	they	PRON
ihlr-18810	629	62	are	be	AUX
ihlr-18810	629	63	proven	prove	VERB
ihlr-18810	629	64	to	to	PART
ihlr-18810	629	65	be	be	AUX
ihlr-18810	629	66	safe	safe	ADJ
ihlr-18810	629	67	and	and	CCONJ
ihlr-18810	629	68	effective	effective	ADJ
ihlr-18810	629	69	,	,	PUNCT
ihlr-18810	629	70	or	or	CCONJ
ihlr-18810	629	71	at	at	ADV
ihlr-18810	629	72	least	least	ADJ
ihlr-18810	629	73	as	as	ADV
ihlr-18810	629	74	safe	safe	ADJ
ihlr-18810	629	75	and	and	CCONJ
ihlr-18810	629	76	effective	effective	ADJ
ihlr-18810	629	77	as	as	ADP
ihlr-18810	629	78	alternative	alternative	ADJ
ihlr-18810	629	79	treatments	treatment	NOUN
ihlr-18810	629	80	available	available	ADJ
ihlr-18810	629	81	.	.	PUNCT
ihlr-18810	630	1	first	first	ADV
ihlr-18810	630	2	,	,	PUNCT
ihlr-18810	630	3	some	some	DET
ihlr-18810	630	4	background	background	NOUN
ihlr-18810	630	5	about	about	ADP
ihlr-18810	630	6	cer	cer	PROPN
ihlr-18810	630	7	may	may	AUX
ihlr-18810	630	8	be	be	AUX
ihlr-18810	630	9	helpful	helpful	ADJ
ihlr-18810	630	10	.	.	PUNCT
ihlr-18810	631	1	studies	study	NOUN
ihlr-18810	631	2	focusing	focus	VERB
ihlr-18810	631	3	on	on	ADP
ihlr-18810	631	4	the	the	DET
ihlr-18810	631	5	efficacy	efficacy	NOUN
ihlr-18810	631	6	of	of	ADP
ihlr-18810	631	7	a	a	DET
ihlr-18810	631	8	device	device	NOUN
ihlr-18810	631	9	,	,	PUNCT
ihlr-18810	631	10	the	the	DET
ihlr-18810	631	11	extent	extent	NOUN
ihlr-18810	631	12	to	to	PART
ihlr-18810	631	13	which	which	PRON
ihlr-18810	631	14	the	the	DET
ihlr-18810	631	15	device	device	NOUN
ihlr-18810	631	16	will	will	AUX
ihlr-18810	631	17	produce	produce	VERB
ihlr-18810	631	18	a	a	DET
ihlr-18810	631	19	beneficial	beneficial	ADJ
ihlr-18810	631	20	result	result	NOUN
ihlr-18810	631	21	,	,	PUNCT
ihlr-18810	631	22	are	be	AUX
ihlr-18810	631	23	known	know	VERB
ihlr-18810	631	24	as	as	ADP
ihlr-18810	631	25	clinical	clinical	ADJ
ihlr-18810	631	26	effectiveness	effectiveness	NOUN
ihlr-18810	631	27	studies.246	studies.246	PROPN
ihlr-18810	631	28	these	these	DET
ihlr-18810	631	29	studies	study	NOUN
ihlr-18810	631	30	may	may	AUX
ihlr-18810	631	31	consider	consider	VERB
ihlr-18810	631	32	the	the	DET
ihlr-18810	631	33	use	use	NOUN
ihlr-18810	631	34	of	of	ADP
ihlr-18810	631	35	the	the	DET
ihlr-18810	631	36	device	device	NOUN
ihlr-18810	631	37	under	under	ADP
ihlr-18810	631	38	ideal	ideal	ADJ
ihlr-18810	631	39	circumstances	circumstance	NOUN
ihlr-18810	631	40	,	,	PUNCT
ihlr-18810	631	41	or	or	CCONJ
ihlr-18810	631	42	its	its	PRON
ihlr-18810	631	43	use	use	NOUN
ihlr-18810	631	44	under	under	ADP
ihlr-18810	631	45	ordinary	ordinary	ADJ
ihlr-18810	631	46	circumstances	circumstance	NOUN
ihlr-18810	631	47	(	(	PUNCT
ihlr-18810	631	48	which	which	PRON
ihlr-18810	631	49	usually	usually	ADV
ihlr-18810	631	50	involves	involve	VERB
ihlr-18810	631	51	a	a	DET
ihlr-18810	631	52	broadening	broadening	NOUN
ihlr-18810	631	53	of	of	ADP
ihlr-18810	631	54	the	the	DET
ihlr-18810	631	55	delivery	delivery	NOUN
ihlr-18810	631	56	settings	setting	NOUN
ihlr-18810	631	57	,	,	PUNCT
ihlr-18810	631	58	patient	patient	ADJ
ihlr-18810	631	59	populations	population	NOUN
ihlr-18810	631	60	,	,	PUNCT
ihlr-18810	631	61	or	or	CCONJ
ihlr-18810	631	62	avail	avail	NOUN
ihlr-18810	631	63	-	-	PUNCT
ihlr-18810	631	64	ability	ability	NOUN
ihlr-18810	631	65	of	of	ADP
ihlr-18810	631	66	alternative	alternative	ADJ
ihlr-18810	631	67	therapies	therapy	NOUN
ihlr-18810	631	68	in	in	ADP
ihlr-18810	631	69	their	their	PRON
ihlr-18810	631	70	analyses).247	analyses).247	ADJ
ihlr-18810	631	71	results	result	NOUN
ihlr-18810	631	72	from	from	ADP
ihlr-18810	631	73	multiple	multiple	ADJ
ihlr-18810	631	74	studies	study	NOUN
ihlr-18810	631	75	can	can	AUX
ihlr-18810	631	76	be	be	AUX
ihlr-18810	631	77	accumulated	accumulate	VERB
ihlr-18810	631	78	and	and	CCONJ
ihlr-18810	631	79	assessed	assess	VERB
ihlr-18810	631	80	as	as	ADP
ihlr-18810	631	81	a	a	DET
ihlr-18810	631	82	group	group	NOUN
ihlr-18810	631	83	,	,	PUNCT
ihlr-18810	631	84	to	to	PART
ihlr-18810	631	85	enable	enable	VERB
ihlr-18810	631	86	conclusions	conclusion	NOUN
ihlr-18810	631	87	of	of	ADP
ihlr-18810	631	88	effectiveness	effectiveness	NOUN
ihlr-18810	631	89	to	to	PART
ihlr-18810	631	90	be	be	AUX
ihlr-18810	631	91	drawn	draw	VERB
ihlr-18810	631	92	that	that	PRON
ihlr-18810	631	93	will	will	AUX
ihlr-18810	631	94	have	have	VERB
ihlr-18810	631	95	sufficient	sufficient	ADJ
ihlr-18810	631	96	weight	weight	NOUN
ihlr-18810	631	97	to	to	PART
ihlr-18810	631	98	be	be	AUX
ihlr-18810	631	99	reasonably	reasonably	ADV
ihlr-18810	631	100	used	use	VERB
ihlr-18810	631	101	in	in	ADP
ihlr-18810	631	102	practice	practice	NOUN
ihlr-18810	631	103	.	.	PUNCT
ihlr-18810	632	1	248	248	NUM
ihlr-18810	632	2	the	the	DET
ihlr-18810	632	3	most	most	ADV
ihlr-18810	632	4	effective	effective	ADJ
ihlr-18810	632	5	use	use	NOUN
ihlr-18810	632	6	of	of	ADP
ihlr-18810	632	7	the	the	DET
ihlr-18810	632	8	information	information	NOUN
ihlr-18810	632	9	obtained	obtain	VERB
ihlr-18810	632	10	through	through	ADP
ihlr-18810	632	11	these	these	DET
ihlr-18810	632	12	clinical	clinical	ADJ
ihlr-18810	632	13	effectiveness	effectiveness	NOUN
ihlr-18810	632	14	studies	study	NOUN
ihlr-18810	632	15	,	,	PUNCT
ihlr-18810	632	16	however	however	ADV
ihlr-18810	632	17	,	,	PUNCT
ihlr-18810	632	18	is	be	AUX
ihlr-18810	632	19	in	in	ADP
ihlr-18810	632	20	244	244	NUM
ihlr-18810	632	21	inst	inst	NOUN
ihlr-18810	632	22	.	.	PUNCT
ihlr-18810	632	23	of	of	ADP
ihlr-18810	632	24	med	med	PROPN
ihlr-18810	632	25	.	.	PROPN
ihlr-18810	632	26	,	,	PUNCT
ihlr-18810	632	27	learning	learn	VERB
ihlr-18810	632	28	what	what	PRON
ihlr-18810	632	29	works	work	VERB
ihlr-18810	632	30	best	well	ADV
ihlr-18810	632	31	:	:	PUNCT
ihlr-18810	632	32	the	the	DET
ihlr-18810	632	33	nation	nation	NOUN
ihlr-18810	632	34	's	's	PART
ihlr-18810	632	35	need	need	NOUN
ihlr-18810	632	36	for	for	ADP
ihlr-18810	632	37	evidence	evidence	NOUN
ihlr-18810	632	38	on	on	ADP
ihlr-18810	632	39	comparative	comparative	ADJ
ihlr-18810	632	40	effectiveness	effectiveness	NOUN
ihlr-18810	632	41	in	in	ADP
ihlr-18810	632	42	health	health	NOUN
ihlr-18810	632	43	care	care	NOUN
ihlr-18810	632	44	6	6	NUM
ihlr-18810	632	45	(	(	PUNCT
ihlr-18810	632	46	2007	2007	NUM
ihlr-18810	632	47	)	)	PUNCT
ihlr-18810	632	48	,	,	PUNCT
ihlr-18810	632	49	available	available	ADJ
ihlr-18810	632	50	at	at	ADP
ihlr-18810	632	51	http://www.iom.edul-/media	http://www.iom.edul-/media	PROPN
ihlr-18810	632	52	/	/	SYM
ihlr-18810	632	53	files	file	NOUN
ihlr-18810	632	54	/	/	SYM
ihlr-18810	632	55	activity%	activity%	NOUN
ihlr-18810	632	56	20files	20file	NOUN
ihlr-18810	632	57	/	/	SYM
ihlr-18810	632	58	quality	quality	NOUN
ihlr-18810	632	59	/	/	SYM
ihlr-18810	632	60	vsrt	vsrt	NOUN
ihlr-18810	632	61	/	/	SYM
ihlr-18810	632	62	comparativeeffectivenesswhitepaperesf.pdf	comparativeeffectivenesswhitepaperesf.pdf	X
ihlr-18810	632	63	[	[	X
ihlr-18810	632	64	hereinafter	hereinafter	NOUN
ihlr-18810	632	65	iomce	iomce	NOUN
ihlr-18810	632	66	]	]	PUNCT
ihlr-18810	632	67	.	.	PUNCT
ihlr-18810	633	1	245	245	NUM
ihlr-18810	633	2	i	i	PRON
ihlr-18810	633	3	d.	d.	PROPN
ihlr-18810	633	4	at	at	ADP
ihlr-18810	633	5	2	2	NUM
ihlr-18810	633	6	.	.	X
ihlr-18810	633	7	246	246	NUM
ihlr-18810	634	1	i	i	PRON
ihlr-18810	634	2	d.	d.	PROPN
ihlr-18810	634	3	at	at	ADP
ihlr-18810	634	4	7	7	NUM
ihlr-18810	634	5	.	.	NUM
ihlr-18810	634	6	247	247	NUM
ihlr-18810	635	1	i	i	NOUN
ihlr-18810	635	2	d.	d.	PROPN
ihlr-18810	635	3	248	248	NUM
ihlr-18810	636	1	i	i	PRON
ihlr-18810	636	2	d.	d.	PROPN
ihlr-18810	636	3	2013	2013	NUM
ihlr-18810	636	4	159	159	NUM
ihlr-18810	636	5	indiana	indiana	PROPN
ihlr-18810	636	6	health	health	PROPN
ihlr-18810	636	7	law	law	PROPN
ihlr-18810	636	8	review	review	NOUN
ihlr-18810	636	9	comparing	compare	VERB
ihlr-18810	636	10	the	the	DET
ihlr-18810	636	11	effectiveness	effectiveness	NOUN
ihlr-18810	636	12	of	of	ADP
ihlr-18810	636	13	alternative	alternative	ADJ
ihlr-18810	636	14	treatment	treatment	NOUN
ihlr-18810	636	15	options	option	NOUN
ihlr-18810	636	16	against	against	ADP
ihlr-18810	636	17	each	each	DET
ihlr-18810	636	18	other	other	ADJ
ihlr-18810	636	19	to	to	PART
ihlr-18810	636	20	provide	provide	VERB
ihlr-18810	636	21	information	information	NOUN
ihlr-18810	636	22	about	about	ADP
ihlr-18810	636	23	the	the	DET
ihlr-18810	636	24	relative	relative	ADJ
ihlr-18810	636	25	outcomes	outcome	NOUN
ihlr-18810	636	26	of	of	ADP
ihlr-18810	636	27	the	the	DET
ihlr-18810	636	28	interventions	intervention	NOUN
ihlr-18810	636	29	,	,	PUNCT
ihlr-18810	636	30	and	and	CCONJ
ihlr-18810	636	31	which	which	PRON
ihlr-18810	636	32	will	will	AUX
ihlr-18810	636	33	be	be	AUX
ihlr-18810	636	34	most	most	ADV
ihlr-18810	636	35	likely	likely	ADJ
ihlr-18810	636	36	to	to	PART
ihlr-18810	636	37	produce	produce	VERB
ihlr-18810	636	38	the	the	DET
ihlr-18810	636	39	best	good	ADJ
ihlr-18810	636	40	patient	patient	ADJ
ihlr-18810	636	41	outcome	outcome	NOUN
ihlr-18810	636	42	in	in	ADP
ihlr-18810	636	43	different	different	ADJ
ihlr-18810	636	44	circumstances	circumstance	NOUN
ihlr-18810	636	45	.	.	PUNCT
ihlr-18810	637	1	2	2	NUM
ihlr-18810	637	2	49	49	NUM
ihlr-18810	637	3	this	this	PRON
ihlr-18810	637	4	is	be	AUX
ihlr-18810	637	5	known	know	VERB
ihlr-18810	637	6	as	as	ADP
ihlr-18810	637	7	comparative	comparative	ADJ
ihlr-18810	637	8	effectiveness	effectiveness	NOUN
ihlr-18810	637	9	research	research	NOUN
ihlr-18810	637	10	,	,	PUNCT
ihlr-18810	637	11	or	or	CCONJ
ihlr-18810	637	12	cer	cer	NOUN
ihlr-18810	637	13	.	.	PUNCT
ihlr-18810	638	1	many	many	ADJ
ihlr-18810	638	2	experts	expert	NOUN
ihlr-18810	638	3	recommend	recommend	VERB
ihlr-18810	638	4	using	use	VERB
ihlr-18810	638	5	the	the	DET
ihlr-18810	638	6	metric	metric	NOUN
ihlr-18810	638	7	of	of	ADP
ihlr-18810	638	8	"	"	PUNCT
ihlr-18810	638	9	quality	quality	NOUN
ihlr-18810	638	10	adjusted	adjust	VERB
ihlr-18810	638	11	life	life	NOUN
ihlr-18810	638	12	-	-	PUNCT
ihlr-18810	638	13	years	year	NOUN
ihlr-18810	638	14	"	"	PUNCT
ihlr-18810	638	15	as	as	ADP
ihlr-18810	638	16	the	the	DET
ihlr-18810	638	17	standard	standard	NOUN
ihlr-18810	638	18	for	for	ADP
ihlr-18810	638	19	measuring	measure	VERB
ihlr-18810	638	20	health	health	NOUN
ihlr-18810	638	21	outcomes.250	outcomes.250	NOUN
ihlr-18810	638	22	this	this	DET
ihlr-18810	638	23	metric	metric	NOUN
ihlr-18810	638	24	would	would	AUX
ihlr-18810	638	25	signify	signify	VERB
ihlr-18810	638	26	the	the	DET
ihlr-18810	638	27	effects	effect	NOUN
ihlr-18810	638	28	of	of	ADP
ihlr-18810	638	29	treatments	treatment	NOUN
ihlr-18810	638	30	in	in	ADP
ihlr-18810	638	31	terms	term	NOUN
ihlr-18810	638	32	of	of	ADP
ihlr-18810	638	33	gains	gain	NOUN
ihlr-18810	638	34	or	or	CCONJ
ihlr-18810	638	35	losses	loss	NOUN
ihlr-18810	638	36	in	in	ADP
ihlr-18810	638	37	time	time	NOUN
ihlr-18810	638	38	spent	spend	VERB
ihlr-18810	638	39	in	in	ADP
ihlr-18810	638	40	any	any	PRON
ihlr-18810	638	41	of	of	ADP
ihlr-18810	638	42	a	a	DET
ihlr-18810	638	43	number	number	NOUN
ihlr-18810	638	44	of	of	ADP
ihlr-18810	638	45	quality	quality	NOUN
ihlr-18810	638	46	-	-	PUNCT
ihlr-18810	638	47	weighted	weight	VERB
ihlr-18810	638	48	health	health	NOUN
ihlr-18810	638	49	statuses	status	NOUN
ihlr-18810	638	50	.	.	PUNCT
ihlr-18810	639	1	in	in	ADP
ihlr-18810	639	2	this	this	DET
ihlr-18810	639	3	way	way	NOUN
ihlr-18810	639	4	,	,	PUNCT
ihlr-18810	639	5	the	the	DET
ihlr-18810	639	6	metric	metric	NOUN
ihlr-18810	639	7	would	would	AUX
ihlr-18810	639	8	enable	enable	VERB
ihlr-18810	639	9	a	a	DET
ihlr-18810	639	10	simple	simple	ADJ
ihlr-18810	639	11	comparison	comparison	NOUN
ihlr-18810	639	12	of	of	ADP
ihlr-18810	639	13	multiple	multiple	ADJ
ihlr-18810	639	14	treatment	treatment	NOUN
ihlr-18810	639	15	options	option	NOUN
ihlr-18810	639	16	over	over	ADP
ihlr-18810	639	17	a	a	DET
ihlr-18810	639	18	range	range	NOUN
ihlr-18810	639	19	of	of	ADP
ihlr-18810	639	20	patient	patient	ADJ
ihlr-18810	639	21	conditions	condition	NOUN
ihlr-18810	639	22	and	and	CCONJ
ihlr-18810	639	23	diseases	disease	NOUN
ihlr-18810	639	24	.	.	PUNCT
ihlr-18810	640	1	251	251	NUM
ihlr-18810	640	2	the	the	DET
ihlr-18810	640	3	utility	utility	NOUN
ihlr-18810	640	4	and	and	CCONJ
ihlr-18810	640	5	relative	relative	ADJ
ihlr-18810	640	6	merits	merit	NOUN
ihlr-18810	640	7	of	of	ADP
ihlr-18810	640	8	different	different	ADJ
ihlr-18810	640	9	interventions	intervention	NOUN
ihlr-18810	640	10	(	(	PUNCT
ihlr-18810	640	11	not	not	PART
ihlr-18810	640	12	limited	limit	VERB
ihlr-18810	640	13	to	to	ADP
ihlr-18810	640	14	devices	device	NOUN
ihlr-18810	640	15	,	,	PUNCT
ihlr-18810	640	16	but	but	CCONJ
ihlr-18810	640	17	also	also	ADV
ihlr-18810	640	18	diagnostic	diagnostic	ADJ
ihlr-18810	640	19	tests	test	NOUN
ihlr-18810	640	20	or	or	CCONJ
ihlr-18810	640	21	surgical	surgical	ADJ
ihlr-18810	640	22	,	,	PUNCT
ihlr-18810	640	23	pharmaceutical	pharmaceutical	NOUN
ihlr-18810	640	24	,	,	PUNCT
ihlr-18810	640	25	or	or	CCONJ
ihlr-18810	640	26	de	de	ADJ
ihlr-18810	640	27	-	-	NOUN
ihlr-18810	640	28	vice	vice	NOUN
ihlr-18810	640	29	treatment	treatment	NOUN
ihlr-18810	640	30	options	option	NOUN
ihlr-18810	640	31	)	)	PUNCT
ihlr-18810	640	32	can	can	AUX
ihlr-18810	640	33	be	be	AUX
ihlr-18810	640	34	obtained	obtain	VERB
ihlr-18810	640	35	through	through	ADP
ihlr-18810	640	36	the	the	DET
ihlr-18810	640	37	cer	cer	NOUN
ihlr-18810	640	38	can	can	AUX
ihlr-18810	640	39	be	be	AUX
ihlr-18810	640	40	directly	directly	ADV
ihlr-18810	640	41	compared	compare	VERB
ihlr-18810	640	42	,	,	PUNCT
ihlr-18810	640	43	enabling	enable	VERB
ihlr-18810	640	44	inferences	inference	NOUN
ihlr-18810	640	45	to	to	PART
ihlr-18810	640	46	be	be	AUX
ihlr-18810	640	47	drawn	draw	VERB
ihlr-18810	640	48	on	on	ADP
ihlr-18810	640	49	the	the	DET
ihlr-18810	640	50	likelihood	likelihood	NOUN
ihlr-18810	640	51	each	each	PRON
ihlr-18810	640	52	has	have	VERB
ihlr-18810	640	53	of	of	ADP
ihlr-18810	640	54	achieving	achieve	VERB
ihlr-18810	640	55	the	the	DET
ihlr-18810	640	56	best	good	ADJ
ihlr-18810	640	57	patient	patient	ADJ
ihlr-18810	640	58	outcome	outcome	NOUN
ihlr-18810	640	59	possible.252	possible.252	PROPN
ihlr-18810	640	60	cer	cer	PROPN
ihlr-18810	640	61	is	be	AUX
ihlr-18810	640	62	not	not	PART
ihlr-18810	640	63	a	a	DET
ihlr-18810	640	64	new	new	ADJ
ihlr-18810	640	65	concept	concept	NOUN
ihlr-18810	640	66	,	,	PUNCT
ihlr-18810	640	67	and	and	CCONJ
ihlr-18810	640	68	in	in	ADP
ihlr-18810	640	69	fact	fact	NOUN
ihlr-18810	640	70	research	research	NOUN
ihlr-18810	640	71	has	have	AUX
ihlr-18810	640	72	been	be	AUX
ihlr-18810	640	73	carried	carry	VERB
ihlr-18810	640	74	out	out	ADP
ihlr-18810	640	75	in	in	ADP
ihlr-18810	640	76	the	the	DET
ihlr-18810	640	77	u.s	u.s	PROPN
ihlr-18810	640	78	.	.	PROPN
ihlr-18810	640	79	for	for	ADP
ihlr-18810	640	80	years	year	NOUN
ihlr-18810	640	81	,	,	PUNCT
ihlr-18810	640	82	primarily	primarily	ADV
ihlr-18810	640	83	under	under	ADP
ihlr-18810	640	84	the	the	DET
ihlr-18810	640	85	auspices	auspex	NOUN
ihlr-18810	640	86	of	of	ADP
ihlr-18810	640	87	the	the	DET
ihlr-18810	640	88	national	national	PROPN
ihlr-18810	640	89	institutes	institutes	PROPN
ihlr-18810	640	90	of	of	ADP
ihlr-18810	640	91	health	health	PROPN
ihlr-18810	640	92	(	(	PUNCT
ihlr-18810	640	93	nih	nih	PROPN
ihlr-18810	640	94	)	)	PUNCT
ihlr-18810	640	95	,	,	PUNCT
ihlr-18810	640	96	the	the	DET
ihlr-18810	640	97	agency	agency	NOUN
ihlr-18810	640	98	for	for	ADP
ihlr-18810	640	99	healthcare	healthcare	PROPN
ihlr-18810	640	100	research	research	NOUN
ihlr-18810	640	101	and	and	CCONJ
ihlr-18810	640	102	quality	quality	NOUN
ihlr-18810	640	103	(	(	PUNCT
ihlr-18810	640	104	ahrq	ahrq	PROPN
ihlr-18810	640	105	)	)	PUNCT
ihlr-18810	640	106	,	,	PUNCT
ihlr-18810	640	107	and	and	CCONJ
ihlr-18810	640	108	the	the	DET
ihlr-18810	640	109	department	department	NOUN
ihlr-18810	640	110	of	of	ADP
ihlr-18810	640	111	veterans	veterans	PROPN
ihlr-18810	640	112	affairs	affairs	PROPN
ihlr-18810	640	113	.	.	PUNCT
ihlr-18810	641	1	253	253	NUM
ihlr-18810	641	2	additionally	additionally	ADV
ihlr-18810	641	3	,	,	PUNCT
ihlr-18810	641	4	the	the	DET
ihlr-18810	641	5	fda	fda	PROPN
ihlr-18810	641	6	,	,	PUNCT
ihlr-18810	641	7	the	the	DET
ihlr-18810	641	8	centers	center	NOUN
ihlr-18810	641	9	for	for	ADP
ihlr-18810	641	10	disease	disease	NOUN
ihlr-18810	641	11	control	control	NOUN
ihlr-18810	641	12	,	,	PUNCT
ihlr-18810	641	13	254	254	NUM
ihlr-18810	641	14	and	and	CCONJ
ihlr-18810	641	15	other	other	ADJ
ihlr-18810	641	16	hhs	hhs	PROPN
ihlr-18810	641	17	agencies	agency	NOUN
ihlr-18810	641	18	have	have	AUX
ihlr-18810	641	19	for	for	ADP
ihlr-18810	641	20	years	year	NOUN
ihlr-18810	641	21	been	be	AUX
ihlr-18810	641	22	contributing	contribute	VERB
ihlr-18810	641	23	to	to	PART
ihlr-18810	641	24	cer.2	cer.2	VERB
ihlr-18810	641	25	55	55	NUM
ihlr-18810	641	26	the	the	DET
ihlr-18810	641	27	basic	basic	ADJ
ihlr-18810	641	28	information	information	NOUN
ihlr-18810	641	29	collected	collect	VERB
ihlr-18810	641	30	by	by	ADP
ihlr-18810	641	31	the	the	DET
ihlr-18810	641	32	fda	fda	PROPN
ihlr-18810	641	33	regarding	regard	VERB
ihlr-18810	641	34	the	the	DET
ihlr-18810	641	35	safety	safety	NOUN
ihlr-18810	641	36	249	249	NUM
ihlr-18810	641	37	i	i	PRON
ihlr-18810	641	38	d.	d.	VERB
ihlr-18810	641	39	at	at	ADP
ihlr-18810	641	40	7	7	NUM
ihlr-18810	641	41	-	-	SYM
ihlr-18810	641	42	8	8	NUM
ihlr-18810	641	43	.	.	PUNCT
ihlr-18810	642	1	250	250	NUM
ihlr-18810	642	2	peter	peter	PROPN
ihlr-18810	642	3	j.	j.	PROPN
ihlr-18810	642	4	neuman	neuman	PROPN
ihlr-18810	642	5	&	&	CCONJ
ihlr-18810	642	6	milton	milton	PROPN
ihlr-18810	642	7	c.	c.	PROPN
ihlr-18810	642	8	weinstein	weinstein	PROPN
ihlr-18810	642	9	,	,	PUNCT
ihlr-18810	642	10	legislating	legislate	VERB
ihlr-18810	642	11	against	against	ADP
ihlr-18810	642	12	use	use	NOUN
ihlr-18810	642	13	of	of	ADP
ihlr-18810	642	14	cost	cost	NOUN
ihlr-18810	642	15	-	-	PUNCT
ihlr-18810	642	16	effectiveness	effectiveness	NOUN
ihlr-18810	642	17	information	information	NOUN
ihlr-18810	642	18	,	,	PUNCT
ihlr-18810	642	19	363	363	NUM
ihlr-18810	642	20	new	new	ADJ
ihlr-18810	642	21	eng	eng	PROPN
ihlr-18810	642	22	.	.	PUNCT
ihlr-18810	642	23	j.	j.	PROPN
ihlr-18810	642	24	med	med	PROPN
ihlr-18810	642	25	.	.	PROPN
ihlr-18810	642	26	1495	1495	NUM
ihlr-18810	642	27	,	,	PUNCT
ihlr-18810	642	28	1495	1495	NUM
ihlr-18810	642	29	(	(	PUNCT
ihlr-18810	642	30	2010	2010	NUM
ihlr-18810	642	31	)	)	PUNCT
ihlr-18810	642	32	.	.	PUNCT
ihlr-18810	643	1	251	251	NUM
ihlr-18810	644	1	i	i	PRON
ihlr-18810	644	2	d.	d.	PROPN
ihlr-18810	644	3	252	252	NUM
ihlr-18810	644	4	iom	iom	PROPN
ihlr-18810	644	5	ce	ce	PROPN
ihlr-18810	644	6	,	,	PUNCT
ihlr-18810	644	7	supra	supra	PROPN
ihlr-18810	644	8	note	note	PROPN
ihlr-18810	644	9	244	244	NUM
ihlr-18810	644	10	,	,	PUNCT
ihlr-18810	644	11	at	at	ADP
ihlr-18810	644	12	8	8	NUM
ihlr-18810	644	13	253	253	NUM
ihlr-18810	644	14	john	john	PROPN
ihlr-18810	644	15	donnelly	donnelly	PROPN
ihlr-18810	644	16	,	,	PUNCT
ihlr-18810	644	17	health	health	NOUN
ihlr-18810	644	18	policy	policy	NOUN
ihlr-18810	644	19	brief	brief	ADJ
ihlr-18810	644	20	comparative	comparative	ADJ
ihlr-18810	644	21	effectiveness	effectiveness	NOUN
ihlr-18810	644	22	research	research	NOUN
ihlr-18810	644	23	,	,	PUNCT
ihlr-18810	644	24	healthaffairs	healthaffairs	PROPN
ihlr-18810	644	25	(	(	PUNCT
ihlr-18810	644	26	oct	oct	PROPN
ihlr-18810	644	27	.	.	PROPN
ihlr-18810	644	28	8	8	NUM
ihlr-18810	644	29	,	,	PUNCT
ihlr-18810	644	30	2010	2010	NUM
ihlr-18810	644	31	)	)	PUNCT
ihlr-18810	644	32	,	,	PUNCT
ihlr-18810	644	33	http://www.healthaffairs.org/	http://www.healthaffairs.org/	NOUN
ihlr-18810	644	34	healthpolicybriefs	healthpolicybrief	NOUN
ihlr-18810	644	35	/	/	SYM
ihlr-18810	644	36	brief.php?brief	brief.php?brief	PROPN
ihlr-18810	644	37	-	-	PUNCT
ihlr-18810	644	38	id=27	id=27	ADJ
ihlr-18810	644	39	(	(	PUNCT
ihlr-18810	644	40	last	last	ADV
ihlr-18810	644	41	visited	visit	VERB
ihlr-18810	644	42	dec	dec	PROPN
ihlr-18810	644	43	.	.	PROPN
ihlr-18810	644	44	27	27	NUM
ihlr-18810	644	45	,	,	PUNCT
ihlr-18810	644	46	2012	2012	NUM
ihlr-18810	644	47	)	)	PUNCT
ihlr-18810	644	48	.	.	PUNCT
ihlr-18810	645	1	254	254	NUM
ihlr-18810	645	2	iom	iom	PROPN
ihlr-18810	645	3	ce	ce	PROPN
ihlr-18810	645	4	,	,	PUNCT
ihlr-18810	645	5	supra	supra	PROPN
ihlr-18810	645	6	note	note	PROPN
ihlr-18810	645	7	244	244	NUM
ihlr-18810	645	8	,	,	PUNCT
ihlr-18810	645	9	at	at	ADP
ihlr-18810	645	10	9	9	NUM
ihlr-18810	645	11	.	.	PUNCT
ihlr-18810	646	1	the	the	DET
ihlr-18810	646	2	cdc	cdc	PROPN
ihlr-18810	646	3	funds	fund	NOUN
ihlr-18810	646	4	research	research	NOUN
ihlr-18810	646	5	used	use	VERB
ihlr-18810	646	6	in	in	ADP
ihlr-18810	646	7	public	public	ADJ
ihlr-18810	646	8	health	health	NOUN
ihlr-18810	646	9	decision	decision	NOUN
ihlr-18810	646	10	services	service	NOUN
ihlr-18810	646	11	and	and	CCONJ
ihlr-18810	646	12	systems	system	NOUN
ihlr-18810	646	13	,	,	PUNCT
ihlr-18810	646	14	some	some	PRON
ihlr-18810	646	15	which	which	PRON
ihlr-18810	646	16	examines	examine	VERB
ihlr-18810	646	17	the	the	DET
ihlr-18810	646	18	effectiveness	effectiveness	NOUN
ihlr-18810	646	19	of	of	ADP
ihlr-18810	646	20	some	some	DET
ihlr-18810	646	21	infectious	infectious	ADJ
ihlr-18810	646	22	disease	disease	NOUN
ihlr-18810	646	23	therapies	therapy	NOUN
ihlr-18810	646	24	or	or	CCONJ
ihlr-18810	646	25	vaccines	vaccine	NOUN
ihlr-18810	646	26	,	,	PUNCT
ihlr-18810	646	27	and	and	CCONJ
ihlr-18810	646	28	maintains	maintain	VERB
ihlr-18810	646	29	a	a	DET
ihlr-18810	646	30	number	number	NOUN
ihlr-18810	646	31	of	of	ADP
ihlr-18810	646	32	national	national	ADJ
ihlr-18810	646	33	data	datum	NOUN
ihlr-18810	646	34	systems	system	NOUN
ihlr-18810	646	35	containing	contain	VERB
ihlr-18810	646	36	information	information	NOUN
ihlr-18810	646	37	important	important	ADJ
ihlr-18810	646	38	for	for	ADP
ihlr-18810	646	39	certain	certain	ADJ
ihlr-18810	646	40	types	type	NOUN
ihlr-18810	646	41	of	of	ADP
ihlr-18810	646	42	clinical	clinical	ADJ
ihlr-18810	646	43	effectiveness	effectiveness	NOUN
ihlr-18810	646	44	studies	study	NOUN
ihlr-18810	646	45	.	.	PUNCT
ihlr-18810	647	1	255	255	NUM
ihlr-18810	648	1	i	i	PRON
ihlr-18810	648	2	d.	d.	NOUN
ihlr-18810	648	3	160	160	NUM
ihlr-18810	648	4	vol	vol	NOUN
ihlr-18810	648	5	.	.	PUNCT
ihlr-18810	649	1	10:1	10:1	NUM
ihlr-18810	649	2	510(k	510(k	X
ihlr-18810	649	3	)	)	PUNCT
ihlr-18810	649	4	clearance	clearance	NOUN
ihlr-18810	649	5	and	and	CCONJ
ihlr-18810	649	6	efficacy	efficacy	NOUN
ihlr-18810	649	7	of	of	ADP
ihlr-18810	649	8	products	product	NOUN
ihlr-18810	649	9	for	for	ADP
ihlr-18810	649	10	which	which	PRON
ihlr-18810	649	11	pma	pma	NOUN
ihlr-18810	649	12	is	be	AUX
ihlr-18810	649	13	required	require	VERB
ihlr-18810	649	14	,	,	PUNCT
ihlr-18810	649	15	as	as	ADV
ihlr-18810	649	16	well	well	ADV
ihlr-18810	649	17	as	as	ADP
ihlr-18810	649	18	the	the	DET
ihlr-18810	649	19	information	information	NOUN
ihlr-18810	649	20	collected	collect	VERB
ihlr-18810	649	21	post	post	NOUN
ihlr-18810	649	22	-	-	NOUN
ihlr-18810	649	23	market	market	NOUN
ihlr-18810	649	24	through	through	ADP
ihlr-18810	649	25	adverseevent	adverseevent	ADJ
ihlr-18810	649	26	reporting	reporting	NOUN
ihlr-18810	649	27	and	and	CCONJ
ihlr-18810	649	28	other	other	ADJ
ihlr-18810	649	29	surveillance	surveillance	NOUN
ihlr-18810	649	30	has	have	AUX
ihlr-18810	649	31	been	be	AUX
ihlr-18810	649	32	used	use	VERB
ihlr-18810	649	33	in	in	ADP
ihlr-18810	649	34	these	these	DET
ihlr-18810	649	35	efforts	effort	NOUN
ihlr-18810	649	36	,	,	PUNCT
ihlr-18810	649	37	and	and	CCONJ
ihlr-18810	649	38	the	the	DET
ihlr-18810	649	39	sentinel	sentinel	ADJ
ihlr-18810	649	40	network	network	NOUN
ihlr-18810	649	41	previously	previously	ADV
ihlr-18810	649	42	discussed	discuss	VERB
ihlr-18810	649	43	will	will	AUX
ihlr-18810	649	44	further	far	ADV
ihlr-18810	649	45	help	help	VERB
ihlr-18810	649	46	in	in	ADP
ihlr-18810	649	47	this	this	DET
ihlr-18810	649	48	respect	respect	NOUN
ihlr-18810	649	49	.	.	PUNCT
ihlr-18810	650	1	256	256	NUM
ihlr-18810	650	2	it	it	PRON
ihlr-18810	650	3	is	be	AUX
ihlr-18810	650	4	important	important	ADJ
ihlr-18810	650	5	to	to	PART
ihlr-18810	650	6	note	note	VERB
ihlr-18810	650	7	that	that	SCONJ
ihlr-18810	650	8	the	the	DET
ihlr-18810	650	9	fda	fda	PROPN
ihlr-18810	650	10	does	do	AUX
ihlr-18810	650	11	not	not	PART
ihlr-18810	650	12	require	require	VERB
ihlr-18810	650	13	information	information	NOUN
ihlr-18810	650	14	of	of	ADP
ihlr-18810	650	15	the	the	DET
ihlr-18810	650	16	comparative	comparative	ADJ
ihlr-18810	650	17	effectiveness	effectiveness	NOUN
ihlr-18810	650	18	of	of	ADP
ihlr-18810	650	19	any	any	DET
ihlr-18810	650	20	product	product	NOUN
ihlr-18810	650	21	in	in	ADP
ihlr-18810	650	22	order	order	NOUN
ihlr-18810	650	23	to	to	PART
ihlr-18810	650	24	grant	grant	VERB
ihlr-18810	650	25	approval	approval	NOUN
ihlr-18810	650	26	;	;	PUNCT
ihlr-18810	650	27	however	however	ADV
ihlr-18810	650	28	,	,	PUNCT
ihlr-18810	650	29	information	information	NOUN
ihlr-18810	650	30	specific	specific	ADJ
ihlr-18810	650	31	to	to	ADP
ihlr-18810	650	32	the	the	DET
ihlr-18810	650	33	product	product	NOUN
ihlr-18810	650	34	of	of	ADP
ihlr-18810	650	35	its	its	PRON
ihlr-18810	650	36	effectiveness	effectiveness	NOUN
ihlr-18810	650	37	for	for	ADP
ihlr-18810	650	38	its	its	PRON
ihlr-18810	650	39	indicated	indicate	VERB
ihlr-18810	650	40	use	use	NOUN
ihlr-18810	650	41	is	be	AUX
ihlr-18810	650	42	required	require	VERB
ihlr-18810	650	43	for	for	ADP
ihlr-18810	650	44	pma	pma	NOUN
ihlr-18810	650	45	.	.	PROPN
ihlr-18810	651	1	2	2	NUM
ihlr-18810	651	2	57	57	NUM
ihlr-18810	651	3	additionally	additionally	ADV
ihlr-18810	651	4	ahrq	ahrq	NOUN
ihlr-18810	651	5	,	,	PUNCT
ihlr-18810	651	6	through	through	ADP
ihlr-18810	651	7	a	a	DET
ihlr-18810	651	8	mandate	mandate	NOUN
ihlr-18810	651	9	contained	contain	VERB
ihlr-18810	651	10	in	in	ADP
ihlr-18810	651	11	the	the	DET
ihlr-18810	651	12	medicare	medicare	PROPN
ihlr-18810	651	13	prescription	prescription	NOUN
ihlr-18810	651	14	drug	drug	NOUN
ihlr-18810	651	15	,	,	PUNCT
ihlr-18810	651	16	improvement	improvement	NOUN
ihlr-18810	651	17	,	,	PUNCT
ihlr-18810	651	18	and	and	CCONJ
ihlr-18810	651	19	modernization	modernization	NOUN
ihlr-18810	651	20	act,2	act,2	NOUN
ihlr-18810	651	21	58	58	NUM
ihlr-18810	651	22	performs	perform	VERB
ihlr-18810	651	23	research	research	NOUN
ihlr-18810	651	24	focusing	focus	VERB
ihlr-18810	651	25	on	on	ADP
ihlr-18810	651	26	patient	patient	ADJ
ihlr-18810	651	27	outcomes	outcome	NOUN
ihlr-18810	651	28	,	,	PUNCT
ihlr-18810	651	29	the	the	DET
ihlr-18810	651	30	appropriateness	appropriateness	NOUN
ihlr-18810	651	31	of	of	ADP
ihlr-18810	651	32	treatments	treatment	NOUN
ihlr-18810	651	33	,	,	PUNCT
ihlr-18810	651	34	and	and	CCONJ
ihlr-18810	651	35	the	the	DET
ihlr-18810	651	36	comparative	comparative	ADJ
ihlr-18810	651	37	effective	effective	NOUN
ihlr-18810	651	38	-	-	PUNCT
ihlr-18810	651	39	ness	ness	NOUN
ihlr-18810	651	40	of	of	ADP
ihlr-18810	651	41	treatments	treatment	NOUN
ihlr-18810	651	42	.	.	PUNCT
ihlr-18810	652	1	in	in	ADP
ihlr-18810	652	2	carrying	carry	VERB
ihlr-18810	652	3	out	out	ADP
ihlr-18810	652	4	this	this	DET
ihlr-18810	652	5	mandate	mandate	NOUN
ihlr-18810	652	6	,	,	PUNCT
ihlr-18810	652	7	ahrq	ahrq	NOUN
ihlr-18810	652	8	created	create	VERB
ihlr-18810	652	9	the	the	DET
ihlr-18810	652	10	effective	effective	ADJ
ihlr-18810	652	11	health	health	NOUN
ihlr-18810	652	12	care	care	NOUN
ihlr-18810	652	13	program	program	NOUN
ihlr-18810	652	14	that	that	PRON
ihlr-18810	652	15	makes	make	VERB
ihlr-18810	652	16	use	use	NOUN
ihlr-18810	652	17	of	of	ADP
ihlr-18810	652	18	existing	exist	VERB
ihlr-18810	652	19	research	research	NOUN
ihlr-18810	652	20	to	to	PART
ihlr-18810	652	21	create	create	VERB
ihlr-18810	652	22	comparative	comparative	ADJ
ihlr-18810	652	23	effectiveness	effectiveness	NOUN
ihlr-18810	652	24	reports	report	NOUN
ihlr-18810	652	25	,	,	PUNCT
ihlr-18810	652	26	identify	identify	VERB
ihlr-18810	652	27	areas	area	NOUN
ihlr-18810	652	28	lacking	lack	VERB
ihlr-18810	652	29	in	in	ADP
ihlr-18810	652	30	information	information	NOUN
ihlr-18810	652	31	about	about	ADP
ihlr-18810	652	32	treatment	treatment	NOUN
ihlr-18810	652	33	effect	effect	NOUN
ihlr-18810	652	34	-	-	PUNCT
ihlr-18810	652	35	tiveness	tiveness	ADJ
ihlr-18810	652	36	,	,	PUNCT
ihlr-18810	652	37	and	and	CCONJ
ihlr-18810	652	38	improve	improve	VERB
ihlr-18810	652	39	the	the	DET
ihlr-18810	652	40	delivery	delivery	NOUN
ihlr-18810	652	41	of	of	ADP
ihlr-18810	652	42	the	the	DET
ihlr-18810	652	43	results	result	NOUN
ihlr-18810	652	44	found	find	VERB
ihlr-18810	652	45	to	to	ADP
ihlr-18810	652	46	providers	provider	NOUN
ihlr-18810	652	47	and	and	CCONJ
ihlr-18810	652	48	others.259	others.259	PRON
ihlr-18810	652	49	national	national	ADJ
ihlr-18810	652	50	interest	interest	NOUN
ihlr-18810	652	51	in	in	ADP
ihlr-18810	652	52	cer	cer	PROPN
ihlr-18810	652	53	has	have	AUX
ihlr-18810	652	54	risen	rise	VERB
ihlr-18810	652	55	over	over	ADP
ihlr-18810	652	56	the	the	DET
ihlr-18810	652	57	years	year	NOUN
ihlr-18810	652	58	,	,	PUNCT
ihlr-18810	652	59	a	a	DET
ihlr-18810	652	60	likely	likely	ADJ
ihlr-18810	652	61	result	result	NOUN
ihlr-18810	652	62	of	of	ADP
ihlr-18810	652	63	the	the	DET
ihlr-18810	652	64	increasing	increase	VERB
ihlr-18810	652	65	costs	cost	NOUN
ihlr-18810	652	66	of	of	ADP
ihlr-18810	652	67	healthcare	healthcare	NOUN
ihlr-18810	652	68	.	.	PUNCT
ihlr-18810	653	1	the	the	DET
ihlr-18810	653	2	american	american	PROPN
ihlr-18810	653	3	recovery	recovery	PROPN
ihlr-18810	653	4	and	and	CCONJ
ihlr-18810	653	5	reinvestment	reinvestment	NOUN
ihlr-18810	653	6	act	act	NOUN
ihlr-18810	653	7	allocated	allocate	VERB
ihlr-18810	653	8	$	$	SYM
ihlr-18810	653	9	1.1	1.1	NUM
ihlr-18810	653	10	billion	billion	NUM
ihlr-18810	653	11	for	for	ADP
ihlr-18810	653	12	conducting	conduct	VERB
ihlr-18810	653	13	cer.2	cer.2	NOUN
ihlr-18810	653	14	60	60	NUM
ihlr-18810	653	15	additionally	additionally	ADV
ihlr-18810	653	16	,	,	PUNCT
ihlr-18810	653	17	the	the	DET
ihlr-18810	653	18	patient	patient	NOUN
ihlr-18810	653	19	protection	protection	NOUN
ihlr-18810	653	20	and	and	CCONJ
ihlr-18810	653	21	affordable	affordable	ADJ
ihlr-18810	653	22	care	care	NOUN
ihlr-18810	653	23	act	act	PROPN
ihlr-18810	653	24	(	(	PUNCT
ihlr-18810	653	25	aca	aca	PROPN
ihlr-18810	653	26	)	)	PUNCT
ihlr-18810	653	27	created	create	VERB
ihlr-18810	653	28	the	the	DET
ihlr-18810	653	29	patient	patient	NOUN
ihlr-18810	653	30	-	-	PUNCT
ihlr-18810	653	31	centered	center	VERB
ihlr-18810	653	32	outcomes	outcome	NOUN
ihlr-18810	653	33	research	research	PROPN
ihlr-18810	653	34	institute	institute	PROPN
ihlr-18810	653	35	(	(	PUNCT
ihlr-18810	653	36	pcori	pcori	ADV
ihlr-18810	653	37	)	)	PUNCT
ihlr-18810	653	38	to	to	PART
ihlr-18810	653	39	conduct	conduct	VERB
ihlr-18810	653	40	comparative	comparative	ADJ
ihlr-18810	653	41	effectiveness	effectiveness	NOUN
ihlr-18810	653	42	research	research	NOUN
ihlr-18810	653	43	.	.	PUNCT
ihlr-18810	654	1	261	261	NUM
ihlr-18810	654	2	the	the	DET
ihlr-18810	654	3	use	use	NOUN
ihlr-18810	654	4	of	of	ADP
ihlr-18810	654	5	cer	cer	PROPN
ihlr-18810	654	6	in	in	ADP
ihlr-18810	654	7	healthcare	healthcare	PROPN
ihlr-18810	654	8	is	be	AUX
ihlr-18810	654	9	not	not	PART
ihlr-18810	654	10	unique	unique	ADJ
ihlr-18810	654	11	to	to	ADP
ihlr-18810	654	12	the	the	DET
ihlr-18810	654	13	u.s	u.s	PROPN
ihlr-18810	654	14	.	.	PROPN
ihlr-18810	654	15	either	either	ADV
ihlr-18810	654	16	,	,	PUNCT
ihlr-18810	654	17	and	and	CCONJ
ihlr-18810	654	18	in	in	ADP
ihlr-18810	654	19	fact	fact	NOUN
ihlr-18810	654	20	has	have	AUX
ihlr-18810	654	21	been	be	AUX
ihlr-18810	654	22	used	use	VERB
ihlr-18810	654	23	by	by	ADP
ihlr-18810	654	24	many	many	ADJ
ihlr-18810	654	25	other	other	ADJ
ihlr-18810	654	26	countries	country	NOUN
ihlr-18810	654	27	for	for	ADP
ihlr-18810	654	28	years	year	NOUN
ihlr-18810	654	29	,	,	PUNCT
ihlr-18810	654	30	both	both	CCONJ
ihlr-18810	654	31	in	in	ADP
ihlr-18810	654	32	coming	come	VERB
ihlr-18810	654	33	up	up	ADP
ihlr-18810	654	34	with	with	ADP
ihlr-18810	654	35	clinical	clinical	ADJ
ihlr-18810	654	36	practice	practice	NOUN
ihlr-18810	654	37	guidelines	guideline	NOUN
ihlr-18810	654	38	256	256	NUM
ihlr-18810	654	39	i	i	PROPN
ihlr-18810	654	40	d.	d.	PROPN
ihlr-18810	654	41	257	257	NUM
ihlr-18810	654	42	see	see	VERB
ihlr-18810	654	43	premarket	premarket	NOUN
ihlr-18810	654	44	approval	approval	NOUN
ihlr-18810	654	45	of	of	ADP
ihlr-18810	654	46	medical	medical	ADJ
ihlr-18810	654	47	devices	device	NOUN
ihlr-18810	654	48	,	,	PUNCT
ihlr-18810	654	49	21	21	NUM
ihlr-18810	654	50	c.f.r	c.f.r	NOUN
ihlr-18810	654	51	.	.	PUNCT
ihlr-18810	655	1	§	§	PROPN
ihlr-18810	655	2	814.20(b)(3)(v)-(vi	814.20(b)(3)(v)-(vi	PROPN
ihlr-18810	655	3	)	)	PUNCT
ihlr-18810	655	4	(	(	PUNCT
ihlr-18810	655	5	2012	2012	NUM
ihlr-18810	655	6	)	)	PUNCT
ihlr-18810	655	7	.	.	PUNCT
ihlr-18810	656	1	258	258	NUM
ihlr-18810	656	2	medicare	medicare	PROPN
ihlr-18810	656	3	prescription	prescription	NOUN
ihlr-18810	656	4	drug	drug	NOUN
ihlr-18810	656	5	,	,	PUNCT
ihlr-18810	656	6	improvement	improvement	NOUN
ihlr-18810	656	7	,	,	PUNCT
ihlr-18810	656	8	and	and	CCONJ
ihlr-18810	656	9	modernization	modernization	NOUN
ihlr-18810	656	10	act	act	NOUN
ihlr-18810	656	11	of	of	ADP
ihlr-18810	656	12	2003	2003	NUM
ihlr-18810	656	13	,	,	PUNCT
ihlr-18810	656	14	pub	pub	NOUN
ihlr-18810	656	15	.	.	PUNCT
ihlr-18810	657	1	l.	l.	PROPN
ihlr-18810	657	2	108	108	NUM
ihlr-18810	657	3	-	-	SYM
ihlr-18810	657	4	173	173	NUM
ihlr-18810	657	5	stat	stat	NOUN
ihlr-18810	657	6	.	.	PUNCT
ihlr-18810	658	1	2066	2066	NUM
ihlr-18810	658	2	(	(	PUNCT
ihlr-18810	658	3	2003	2003	NUM
ihlr-18810	658	4	)	)	PUNCT
ihlr-18810	658	5	(	(	PUNCT
ihlr-18810	658	6	codified	codify	VERB
ihlr-18810	658	7	in	in	ADP
ihlr-18810	658	8	42	42	NUM
ihlr-18810	658	9	u.s.c	u.s.c	ADJ
ihlr-18810	658	10	.	.	PUNCT
ihlr-18810	659	1	§	§	PROPN
ihlr-18810	659	2	299(b)-(7	299(b)-(7	PROPN
ihlr-18810	659	3	)	)	PUNCT
ihlr-18810	659	4	(	(	PUNCT
ihlr-18810	659	5	2012	2012	NUM
ihlr-18810	659	6	)	)	PUNCT
ihlr-18810	659	7	)	)	PUNCT
ihlr-18810	659	8	.	.	PUNCT
ihlr-18810	660	1	259	259	NUM
ihlr-18810	660	2	iom	iom	PROPN
ihlr-18810	660	3	ce	ce	PROPN
ihlr-18810	660	4	,	,	PUNCT
ihlr-18810	660	5	supra	supra	PROPN
ihlr-18810	660	6	note	note	PROPN
ihlr-18810	660	7	244	244	NUM
ihlr-18810	660	8	,	,	PUNCT
ihlr-18810	660	9	at	at	ADP
ihlr-18810	660	10	9	9	NUM
ihlr-18810	660	11	.	.	NOUN
ihlr-18810	660	12	260	260	NUM
ihlr-18810	660	13	recovery	recovery	NOUN
ihlr-18810	660	14	act	act	NOUN
ihlr-18810	660	15	allocates	allocate	VERB
ihlr-18810	660	16	$	$	SYM
ihlr-18810	660	17	1.1	1.1	NUM
ihlr-18810	660	18	billion	billion	NUM
ihlr-18810	660	19	for	for	ADP
ihlr-18810	660	20	comparative	comparative	ADJ
ihlr-18810	660	21	effectiveness	effectiveness	NOUN
ihlr-18810	660	22	research	research	NOUN
ihlr-18810	660	23	,	,	PUNCT
ihlr-18810	660	24	hhs.gov	hhs.gov	PROPN
ihlr-18810	660	25	,	,	PUNCT
ihlr-18810	660	26	http://www.hhs.gov/recovery/	http://www.hhs.gov/recovery/	NOUN
ihlr-18810	660	27	programs	program	NOUN
ihlr-18810	660	28	/	/	SYM
ihlr-18810	660	29	os	os	NOUN
ihlr-18810	660	30	/	/	SYM
ihlr-18810	660	31	cerbios.html	cerbios.html	PROPN
ihlr-18810	660	32	(	(	PUNCT
ihlr-18810	660	33	last	last	ADV
ihlr-18810	660	34	visited	visit	VERB
ihlr-18810	660	35	dec	dec	PROPN
ihlr-18810	660	36	.	.	PROPN
ihlr-18810	660	37	2	2	NUM
ihlr-18810	660	38	,	,	PUNCT
ihlr-18810	660	39	2012	2012	NUM
ihlr-18810	660	40	)	)	PUNCT
ihlr-18810	660	41	.	.	PUNCT
ihlr-18810	661	1	261	261	NUM
ihlr-18810	661	2	patient	patient	ADJ
ihlr-18810	661	3	protection	protection	NOUN
ihlr-18810	661	4	and	and	CCONJ
ihlr-18810	661	5	affordable	affordable	ADJ
ihlr-18810	661	6	care	care	PROPN
ihlr-18810	661	7	act	act	PROPN
ihlr-18810	661	8	,	,	PUNCT
ihlr-18810	661	9	pub	pub	NOUN
ihlr-18810	661	10	.	.	PUNCT
ihlr-18810	662	1	l.	l.	PROPN
ihlr-18810	662	2	no	no	INTJ
ihlr-18810	662	3	.	.	NOUN
ihlr-18810	663	1	111	111	NUM
ihlr-18810	663	2	-	-	SYM
ihlr-18810	663	3	148	148	NUM
ihlr-18810	663	4	§	§	PROPN
ihlr-18810	663	5	1181(b	1181(b	NUM
ihlr-18810	663	6	)	)	PUNCT
ihlr-18810	663	7	,	,	PUNCT
ihlr-18810	663	8	124	124	NUM
ihlr-18810	663	9	stat	stat	NOUN
ihlr-18810	663	10	.	.	PUNCT
ihlr-18810	664	1	119	119	NUM
ihlr-18810	664	2	(	(	PUNCT
ihlr-18810	664	3	2010	2010	NUM
ihlr-18810	664	4	)	)	PUNCT
ihlr-18810	664	5	.	.	PUNCT
ihlr-18810	665	1	2013	2013	NUM
ihlr-18810	665	2	161	161	NUM
ihlr-18810	665	3	indiana	indiana	PROPN
ihlr-18810	665	4	health	health	PROPN
ihlr-18810	665	5	law	law	NOUN
ihlr-18810	665	6	review	review	NOUN
ihlr-18810	665	7	as	as	ADV
ihlr-18810	665	8	well	well	ADV
ihlr-18810	665	9	as	as	ADP
ihlr-18810	665	10	in	in	ADP
ihlr-18810	665	11	making	make	VERB
ihlr-18810	665	12	coverage	coverage	NOUN
ihlr-18810	665	13	determinations	determination	NOUN
ihlr-18810	665	14	for	for	ADP
ihlr-18810	665	15	government	government	NOUN
ihlr-18810	665	16	health	health	NOUN
ihlr-18810	665	17	plans	plan	NOUN
ihlr-18810	665	18	.	.	PUNCT
ihlr-18810	666	1	the	the	DET
ihlr-18810	666	2	uses	use	NOUN
ihlr-18810	666	3	of	of	ADP
ihlr-18810	666	4	cer	cer	PROPN
ihlr-18810	666	5	among	among	ADP
ihlr-18810	666	6	these	these	DET
ihlr-18810	666	7	countries	country	NOUN
ihlr-18810	666	8	share	share	VERB
ihlr-18810	666	9	some	some	DET
ihlr-18810	666	10	common	common	ADJ
ihlr-18810	666	11	traits	trait	NOUN
ihlr-18810	666	12	,	,	PUNCT
ihlr-18810	666	13	which	which	PRON
ihlr-18810	666	14	the	the	DET
ihlr-18810	666	15	u.s	u.s	PROPN
ihlr-18810	666	16	.	.	PROPN
ihlr-18810	666	17	can	can	AUX
ihlr-18810	666	18	learn	learn	VERB
ihlr-18810	666	19	from	from	ADP
ihlr-18810	666	20	in	in	ADP
ihlr-18810	666	21	making	make	VERB
ihlr-18810	666	22	the	the	DET
ihlr-18810	666	23	best	good	ADJ
ihlr-18810	666	24	use	use	NOUN
ihlr-18810	666	25	of	of	ADP
ihlr-18810	666	26	its	its	PRON
ihlr-18810	666	27	own	own	ADJ
ihlr-18810	666	28	comparative	comparative	ADJ
ihlr-18810	666	29	effectiveness	effectiveness	NOUN
ihlr-18810	666	30	information	information	NOUN
ihlr-18810	666	31	.	.	PUNCT
ihlr-18810	667	1	one	one	NUM
ihlr-18810	667	2	important	important	ADJ
ihlr-18810	667	3	commonality	commonality	NOUN
ihlr-18810	667	4	among	among	ADP
ihlr-18810	667	5	nations	nation	NOUN
ihlr-18810	667	6	is	be	AUX
ihlr-18810	667	7	the	the	DET
ihlr-18810	667	8	independence	independence	NOUN
ihlr-18810	667	9	of	of	ADP
ihlr-18810	667	10	the	the	DET
ihlr-18810	667	11	entities	entity	NOUN
ihlr-18810	667	12	responsible	responsible	ADJ
ihlr-18810	667	13	for	for	ADP
ihlr-18810	667	14	making	make	VERB
ihlr-18810	667	15	comparative	comparative	ADJ
ihlr-18810	667	16	effectiveness	effectiveness	NOUN
ihlr-18810	667	17	recommendations	recommendation	NOUN
ihlr-18810	667	18	have	have	VERB
ihlr-18810	667	19	from	from	ADP
ihlr-18810	667	20	the	the	DET
ihlr-18810	667	21	government	government	NOUN
ihlr-18810	667	22	.	.	PUNCT
ihlr-18810	668	1	262	262	NUM
ihlr-18810	668	2	although	although	SCONJ
ihlr-18810	668	3	many	many	ADJ
ihlr-18810	668	4	are	be	AUX
ihlr-18810	668	5	created	create	VERB
ihlr-18810	668	6	andlor	andlor	NOUN
ihlr-18810	668	7	funded	fund	VERB
ihlr-18810	668	8	by	by	ADP
ihlr-18810	668	9	the	the	DET
ihlr-18810	668	10	nation	nation	NOUN
ihlr-18810	668	11	's	's	PART
ihlr-18810	668	12	government	government	NOUN
ihlr-18810	668	13	,	,	PUNCT
ihlr-18810	668	14	the	the	DET
ihlr-18810	668	15	entities	entity	NOUN
ihlr-18810	668	16	operate	operate	VERB
ihlr-18810	668	17	independently	independently	ADV
ihlr-18810	668	18	and	and	CCONJ
ihlr-18810	668	19	include	include	VERB
ihlr-18810	668	20	all	all	DET
ihlr-18810	668	21	stakeholders	stakeholder	NOUN
ihlr-18810	668	22	in	in	ADP
ihlr-18810	668	23	the	the	DET
ihlr-18810	668	24	decision	decision	NOUN
ihlr-18810	668	25	-	-	PUNCT
ihlr-18810	668	26	making	make	VERB
ihlr-18810	668	27	and	and	CCONJ
ihlr-18810	668	28	methodology	methodology	NOUN
ihlr-18810	668	29	design	design	NOUN
ihlr-18810	668	30	processes	process	NOUN
ihlr-18810	668	31	.	.	PUNCT
ihlr-18810	669	1	263	263	NUM
ihlr-18810	669	2	additionally	additionally	ADV
ihlr-18810	669	3	,	,	PUNCT
ihlr-18810	669	4	most	most	ADJ
ihlr-18810	669	5	of	of	ADP
ihlr-18810	669	6	these	these	DET
ihlr-18810	669	7	entities	entity	NOUN
ihlr-18810	669	8	have	have	AUX
ihlr-18810	669	9	been	be	AUX
ihlr-18810	669	10	able	able	ADJ
ihlr-18810	669	11	to	to	PART
ihlr-18810	669	12	gain	gain	VERB
ihlr-18810	669	13	stakeholder	stakeholder	NOUN
ihlr-18810	669	14	support	support	NOUN
ihlr-18810	669	15	by	by	ADP
ihlr-18810	669	16	including	include	VERB
ihlr-18810	669	17	all	all	DET
ihlr-18810	669	18	stakeholders	stakeholder	NOUN
ihlr-18810	669	19	,	,	PUNCT
ihlr-18810	669	20	especially	especially	ADV
ihlr-18810	669	21	manufacturers	manufacturer	NOUN
ihlr-18810	669	22	,	,	PUNCT
ihlr-18810	669	23	in	in	ADP
ihlr-18810	669	24	the	the	DET
ihlr-18810	669	25	design	design	NOUN
ihlr-18810	669	26	of	of	ADP
ihlr-18810	669	27	the	the	DET
ihlr-18810	669	28	program	program	NOUN
ihlr-18810	669	29	and	and	CCONJ
ihlr-18810	669	30	the	the	DET
ihlr-18810	669	31	decision	decision	NOUN
ihlr-18810	669	32	-	-	PUNCT
ihlr-18810	669	33	making	make	VERB
ihlr-18810	669	34	process	process	NOUN
ihlr-18810	669	35	,	,	PUNCT
ihlr-18810	669	36	264	264	NUM
ihlr-18810	669	37	and	and	CCONJ
ihlr-18810	669	38	making	make	VERB
ihlr-18810	669	39	much	much	ADJ
ihlr-18810	669	40	of	of	ADP
ihlr-18810	669	41	the	the	DET
ihlr-18810	669	42	information	information	NOUN
ihlr-18810	669	43	relied	rely	VERB
ihlr-18810	669	44	upon	upon	SCONJ
ihlr-18810	669	45	in	in	ADP
ihlr-18810	669	46	making	make	VERB
ihlr-18810	669	47	comparative	comparative	ADJ
ihlr-18810	669	48	effectiveness	effectiveness	NOUN
ihlr-18810	669	49	determinations	determination	NOUN
ihlr-18810	669	50	available	available	ADJ
ihlr-18810	669	51	to	to	ADP
ihlr-18810	669	52	the	the	DET
ihlr-18810	669	53	public.265	public.265	NOUN
ihlr-18810	669	54	this	this	PRON
ihlr-18810	669	55	will	will	AUX
ihlr-18810	669	56	be	be	AUX
ihlr-18810	669	57	important	important	ADJ
ihlr-18810	669	58	in	in	ADP
ihlr-18810	669	59	not	not	PART
ihlr-18810	669	60	only	only	ADV
ihlr-18810	669	61	ensuring	ensure	VERB
ihlr-18810	669	62	the	the	DET
ihlr-18810	669	63	decisions	decision	NOUN
ihlr-18810	669	64	reached	reach	VERB
ihlr-18810	669	65	will	will	AUX
ihlr-18810	669	66	have	have	VERB
ihlr-18810	669	67	con	con	NOUN
ihlr-18810	669	68	-	-	PUNCT
ihlr-18810	669	69	sidered	sidere	VERB
ihlr-18810	669	70	all	all	DET
ihlr-18810	669	71	sides	side	NOUN
ihlr-18810	669	72	of	of	ADP
ihlr-18810	669	73	an	an	DET
ihlr-18810	669	74	issue	issue	NOUN
ihlr-18810	669	75	,	,	PUNCT
ihlr-18810	669	76	but	but	CCONJ
ihlr-18810	669	77	also	also	ADV
ihlr-18810	669	78	ensuring	ensure	VERB
ihlr-18810	669	79	the	the	DET
ihlr-18810	669	80	affordability	affordability	NOUN
ihlr-18810	669	81	and	and	CCONJ
ihlr-18810	669	82	completeness	completeness	NOUN
ihlr-18810	669	83	of	of	ADP
ihlr-18810	669	84	information	information	NOUN
ihlr-18810	669	85	upon	upon	SCONJ
ihlr-18810	669	86	which	which	PRON
ihlr-18810	669	87	decisions	decision	NOUN
ihlr-18810	669	88	can	can	AUX
ihlr-18810	669	89	be	be	AUX
ihlr-18810	669	90	based	base	VERB
ihlr-18810	669	91	,	,	PUNCT
ihlr-18810	669	92	since	since	SCONJ
ihlr-18810	669	93	the	the	DET
ihlr-18810	669	94	sector	sector	NOUN
ihlr-18810	669	95	with	with	ADP
ihlr-18810	669	96	the	the	DET
ihlr-18810	669	97	best	good	ADJ
ihlr-18810	669	98	capacity	capacity	NOUN
ihlr-18810	669	99	to	to	PART
ihlr-18810	669	100	generate	generate	VERB
ihlr-18810	669	101	and	and	CCONJ
ihlr-18810	669	102	apply	apply	VERB
ihlr-18810	669	103	comparative	comparative	ADJ
ihlr-18810	669	104	effectiveness	effectiveness	NOUN
ihlr-18810	669	105	information	information	NOUN
ihlr-18810	669	106	is	be	AUX
ihlr-18810	669	107	the	the	DET
ihlr-18810	669	108	manufacturing	manufacturing	NOUN
ihlr-18810	669	109	sector.266	sector.266	ADP
ihlr-18810	669	110	establishing	establish	VERB
ihlr-18810	669	111	an	an	DET
ihlr-18810	669	112	appeals	appeal	NOUN
ihlr-18810	669	113	process	process	NOUN
ihlr-18810	669	114	by	by	ADP
ihlr-18810	669	115	which	which	PRON
ihlr-18810	669	116	comparative	comparative	ADJ
ihlr-18810	669	117	effectiveness	effectiveness	NOUN
ihlr-18810	669	118	decisions	decision	NOUN
ihlr-18810	669	119	may	may	AUX
ihlr-18810	669	120	be	be	AUX
ihlr-18810	669	121	challenged	challenge	VERB
ihlr-18810	669	122	by	by	ADP
ihlr-18810	669	123	interested	interested	ADJ
ihlr-18810	669	124	parties	party	NOUN
ihlr-18810	669	125	will	will	AUX
ihlr-18810	669	126	also	also	ADV
ihlr-18810	669	127	be	be	AUX
ihlr-18810	669	128	important	important	ADJ
ihlr-18810	669	129	in	in	ADP
ihlr-18810	669	130	gaining	gain	VERB
ihlr-18810	669	131	support	support	NOUN
ihlr-18810	669	132	from	from	ADP
ihlr-18810	669	133	stakeholders	stakeholder	NOUN
ihlr-18810	669	134	and	and	CCONJ
ihlr-18810	669	135	the	the	DET
ihlr-18810	669	136	public	public	NOUN
ihlr-18810	669	137	,	,	PUNCT
ihlr-18810	669	138	as	as	ADV
ihlr-18810	669	139	well	well	ADV
ihlr-18810	669	140	as	as	ADP
ihlr-18810	669	141	ensuring	ensure	VERB
ihlr-18810	669	142	decisions	decision	NOUN
ihlr-18810	669	143	are	be	AUX
ihlr-18810	669	144	accurate	accurate	ADJ
ihlr-18810	669	145	based	base	VERB
ihlr-18810	669	146	on	on	ADP
ihlr-18810	669	147	262	262	NUM
ihlr-18810	669	148	kalipso	kalipso	NOUN
ihlr-18810	669	149	chalkidou	chalkidou	PROPN
ihlr-18810	669	150	&	&	CCONJ
ihlr-18810	669	151	gerard	gerard	PROPN
ihlr-18810	669	152	anderson	anderson	PROPN
ihlr-18810	669	153	,	,	PUNCT
ihlr-18810	669	154	comparative	comparative	ADJ
ihlr-18810	669	155	effectiveness	effectiveness	NOUN
ihlr-18810	669	156	research	research	NOUN
ihlr-18810	669	157	:	:	PUNCT
ihlr-18810	669	158	international	international	ADJ
ihlr-18810	669	159	experiences	experience	NOUN
ihlr-18810	669	160	and	and	CCONJ
ihlr-18810	669	161	implications	implication	NOUN
ihlr-18810	669	162	for	for	ADP
ihlr-18810	669	163	the	the	DET
ihlr-18810	669	164	united	united	PROPN
ihlr-18810	669	165	states	states	PROPN
ihlr-18810	669	166	3	3	NUM
ihlr-18810	669	167	(	(	PUNCT
ihlr-18810	669	168	2009	2009	NUM
ihlr-18810	669	169	)	)	PUNCT
ihlr-18810	669	170	,	,	PUNCT
ihlr-18810	669	171	available	available	ADJ
ihlr-18810	669	172	at	at	ADP
ihlr-18810	669	173	http://www.academyhealth.org/files/publications/cerinternational	http://www.academyhealth.org/files/publications/cerinternational	ADJ
ihlr-18810	669	174	_	_	ADJ
ihlr-18810	669	175	experience_09%20(3).pdf	experience_09%20(3).pdf	NOUN
ihlr-18810	669	176	.	.	PUNCT
ihlr-18810	670	1	263	263	NUM
ihlr-18810	671	1	i	i	PRON
ihlr-18810	671	2	d.	d.	VERB
ihlr-18810	671	3	at	at	ADP
ihlr-18810	671	4	3	3	NUM
ihlr-18810	671	5	-	-	SYM
ihlr-18810	671	6	4	4	NUM
ihlr-18810	671	7	.	.	NOUN
ihlr-18810	671	8	264	264	NUM
ihlr-18810	672	1	i	i	PRON
ihlr-18810	672	2	d.	d.	PROPN
ihlr-18810	672	3	at	at	ADP
ihlr-18810	672	4	3	3	NUM
ihlr-18810	672	5	.	.	NUM
ihlr-18810	672	6	265	265	NUM
ihlr-18810	672	7	see	see	VERB
ihlr-18810	672	8	i	i	PRON
ihlr-18810	672	9	d.	d.	PROPN
ihlr-18810	672	10	at	at	ADP
ihlr-18810	672	11	3	3	NUM
ihlr-18810	672	12	.	.	PUNCT
ihlr-18810	673	1	for	for	ADP
ihlr-18810	673	2	example	example	NOUN
ihlr-18810	673	3	,	,	PUNCT
ihlr-18810	673	4	the	the	DET
ihlr-18810	673	5	united	united	PROPN
ihlr-18810	673	6	kingdom	kingdom	PROPN
ihlr-18810	673	7	's	's	PART
ihlr-18810	673	8	national	national	PROPN
ihlr-18810	673	9	institute	institute	NOUN
ihlr-18810	673	10	for	for	ADP
ihlr-18810	673	11	clinical	clinical	ADJ
ihlr-18810	673	12	excellence	excellence	NOUN
ihlr-18810	673	13	,	,	PUNCT
ihlr-18810	673	14	makes	make	VERB
ihlr-18810	673	15	all	all	DET
ihlr-18810	673	16	information	information	NOUN
ihlr-18810	673	17	upon	upon	SCONJ
ihlr-18810	673	18	which	which	PRON
ihlr-18810	673	19	its	its	PRON
ihlr-18810	673	20	decisions	decision	NOUN
ihlr-18810	673	21	are	be	AUX
ihlr-18810	673	22	based	base	VERB
ihlr-18810	673	23	available	available	ADJ
ihlr-18810	673	24	to	to	ADP
ihlr-18810	673	25	the	the	DET
ihlr-18810	673	26	public	public	NOUN
ihlr-18810	673	27	.	.	PUNCT
ihlr-18810	674	1	all	all	DET
ihlr-18810	674	2	confidential	confidential	ADJ
ihlr-18810	674	3	information	information	NOUN
ihlr-18810	674	4	is	be	AUX
ihlr-18810	674	5	carefully	carefully	ADV
ihlr-18810	674	6	scrutinized	scrutinize	VERB
ihlr-18810	674	7	by	by	ADP
ihlr-18810	674	8	the	the	DET
ihlr-18810	674	9	institute	institute	NOUN
ihlr-18810	674	10	,	,	PUNCT
ihlr-18810	674	11	and	and	CCONJ
ihlr-18810	674	12	it	it	PRON
ihlr-18810	674	13	encourages	encourage	VERB
ihlr-18810	674	14	the	the	DET
ihlr-18810	674	15	sources	source	NOUN
ihlr-18810	674	16	of	of	ADP
ihlr-18810	674	17	such	such	ADJ
ihlr-18810	674	18	confidential	confidential	ADJ
ihlr-18810	674	19	information	information	NOUN
ihlr-18810	674	20	to	to	PART
ihlr-18810	674	21	make	make	VERB
ihlr-18810	674	22	it	it	PRON
ihlr-18810	674	23	available	available	ADJ
ihlr-18810	674	24	to	to	ADP
ihlr-18810	674	25	the	the	DET
ihlr-18810	674	26	public	public	NOUN
ihlr-18810	674	27	as	as	ADV
ihlr-18810	674	28	soon	soon	ADV
ihlr-18810	674	29	as	as	ADP
ihlr-18810	674	30	possible	possible	ADJ
ihlr-18810	674	31	.	.	PUNCT
ihlr-18810	675	1	266	266	NUM
ihlr-18810	675	2	iom	iom	PROPN
ihlr-18810	675	3	ce	ce	PROPN
ihlr-18810	675	4	,	,	PUNCT
ihlr-18810	675	5	supra	supra	PROPN
ihlr-18810	675	6	note	note	PROPN
ihlr-18810	675	7	244	244	NUM
ihlr-18810	675	8	,	,	PUNCT
ihlr-18810	675	9	at	at	ADP
ihlr-18810	675	10	5	5	NUM
ihlr-18810	675	11	.	.	PUNCT
ihlr-18810	675	12	vol	vol	NOUN
ihlr-18810	675	13	.	.	PUNCT
ihlr-18810	676	1	10:1162	10:1162	X
ihlr-18810	677	1	510(k	510(k	X
ihlr-18810	677	2	)	)	PUNCT
ihlr-18810	677	3	clearance	clearance	NOUN
ihlr-18810	677	4	the	the	DET
ihlr-18810	677	5	data	datum	NOUN
ihlr-18810	677	6	available	available	ADJ
ihlr-18810	677	7	at	at	ADP
ihlr-18810	677	8	the	the	DET
ihlr-18810	677	9	time	time	NOUN
ihlr-18810	677	10	.	.	PUNCT
ihlr-18810	678	1	26	26	NUM
ihlr-18810	678	2	7	7	NUM
ihlr-18810	678	3	another	another	DET
ihlr-18810	678	4	important	important	ADJ
ihlr-18810	678	5	quality	quality	NOUN
ihlr-18810	678	6	common	common	ADJ
ihlr-18810	678	7	among	among	ADP
ihlr-18810	678	8	these	these	DET
ihlr-18810	678	9	countries	country	NOUN
ihlr-18810	678	10	is	be	AUX
ihlr-18810	678	11	the	the	DET
ihlr-18810	678	12	modest	modest	ADJ
ihlr-18810	678	13	budget	budget	NOUN
ihlr-18810	678	14	and	and	CCONJ
ihlr-18810	678	15	small	small	ADJ
ihlr-18810	678	16	number	number	NOUN
ihlr-18810	678	17	of	of	ADP
ihlr-18810	678	18	people	people	NOUN
ihlr-18810	678	19	needed	need	VERB
ihlr-18810	678	20	to	to	PART
ihlr-18810	678	21	operate	operate	VERB
ihlr-18810	678	22	the	the	DET
ihlr-18810	678	23	entities	entity	NOUN
ihlr-18810	678	24	responsible	responsible	ADJ
ihlr-18810	678	25	for	for	ADP
ihlr-18810	678	26	drawing	draw	VERB
ihlr-18810	678	27	conclusions	conclusion	NOUN
ihlr-18810	678	28	from	from	ADP
ihlr-18810	678	29	and	and	CCONJ
ihlr-18810	678	30	making	make	VERB
ihlr-18810	678	31	recommendations	recommendation	NOUN
ihlr-18810	678	32	based	base	VERB
ihlr-18810	678	33	on	on	ADP
ihlr-18810	678	34	cer.268	cer.268	PROPN
ihlr-18810	678	35	most	most	ADJ
ihlr-18810	678	36	of	of	ADP
ihlr-18810	678	37	these	these	DET
ihlr-18810	678	38	entities	entity	NOUN
ihlr-18810	678	39	require	require	VERB
ihlr-18810	678	40	only	only	ADV
ihlr-18810	678	41	a	a	DET
ihlr-18810	678	42	few	few	ADJ
ihlr-18810	678	43	hundred	hundred	NUM
ihlr-18810	678	44	employees	employee	NOUN
ihlr-18810	678	45	to	to	PART
ihlr-18810	678	46	effectively	effectively	ADV
ihlr-18810	678	47	carry	carry	VERB
ihlr-18810	678	48	out	out	ADP
ihlr-18810	678	49	their	their	PRON
ihlr-18810	678	50	duties	duty	NOUN
ihlr-18810	678	51	,	,	PUNCT
ihlr-18810	678	52	and	and	CCONJ
ihlr-18810	678	53	have	have	AUX
ihlr-18810	678	54	operating	operate	VERB
ihlr-18810	678	55	budgets	budget	NOUN
ihlr-18810	678	56	of	of	ADP
ihlr-18810	678	57	less	less	ADJ
ihlr-18810	678	58	than	than	ADP
ihlr-18810	678	59	$	$	SYM
ihlr-18810	678	60	60	60	NUM
ihlr-18810	678	61	million.269	million.269	NOUN
ihlr-18810	678	62	to	to	PART
ihlr-18810	678	63	make	make	VERB
ihlr-18810	678	64	these	these	DET
ihlr-18810	678	65	benefits	benefit	NOUN
ihlr-18810	678	66	possible	possible	ADJ
ihlr-18810	678	67	,	,	PUNCT
ihlr-18810	678	68	many	many	ADJ
ihlr-18810	678	69	of	of	ADP
ihlr-18810	678	70	the	the	DET
ihlr-18810	678	71	entities	entity	NOUN
ihlr-18810	678	72	rely	rely	VERB
ihlr-18810	678	73	on	on	ADP
ihlr-18810	678	74	other	other	ADJ
ihlr-18810	678	75	bodies	body	NOUN
ihlr-18810	678	76	to	to	PART
ihlr-18810	678	77	conduct	conduct	VERB
ihlr-18810	678	78	the	the	DET
ihlr-18810	678	79	research	research	NOUN
ihlr-18810	678	80	necessary	necessary	ADJ
ihlr-18810	678	81	to	to	PART
ihlr-18810	678	82	arrive	arrive	VERB
ihlr-18810	678	83	at	at	ADP
ihlr-18810	678	84	their	their	PRON
ihlr-18810	678	85	conclusions	conclusion	NOUN
ihlr-18810	678	86	,	,	PUNCT
ihlr-18810	678	87	270	270	NUM
ihlr-18810	678	88	much	much	ADV
ihlr-18810	678	89	as	as	SCONJ
ihlr-18810	678	90	ahrq	ahrq	PROPN
ihlr-18810	678	91	and	and	CCONJ
ihlr-18810	678	92	pcori	pcori	ADV
ihlr-18810	678	93	are	be	AUX
ihlr-18810	678	94	already	already	ADV
ihlr-18810	678	95	able	able	ADJ
ihlr-18810	678	96	to	to	PART
ihlr-18810	678	97	make	make	VERB
ihlr-18810	678	98	use	use	NOUN
ihlr-18810	678	99	of	of	ADP
ihlr-18810	678	100	research	research	NOUN
ihlr-18810	678	101	conducted	conduct	VERB
ihlr-18810	678	102	through	through	ADP
ihlr-18810	678	103	other	other	ADJ
ihlr-18810	678	104	government	government	NOUN
ihlr-18810	678	105	entities	entity	NOUN
ihlr-18810	678	106	and	and	CCONJ
ihlr-18810	678	107	the	the	DET
ihlr-18810	678	108	private	private	ADJ
ihlr-18810	678	109	industry	industry	NOUN
ihlr-18810	678	110	(	(	PUNCT
ihlr-18810	678	111	made	make	VERB
ihlr-18810	678	112	available	available	ADJ
ihlr-18810	678	113	through	through	ADP
ihlr-18810	678	114	fda	fda	PROPN
ihlr-18810	678	115	filings	filing	NOUN
ihlr-18810	678	116	and	and	CCONJ
ihlr-18810	678	117	reporting	reporting	NOUN
ihlr-18810	678	118	)	)	PUNCT
ihlr-18810	678	119	.	.	PUNCT
ihlr-18810	679	1	this	this	PRON
ihlr-18810	679	2	supports	support	VERB
ihlr-18810	679	3	the	the	DET
ihlr-18810	679	4	prediction	prediction	NOUN
ihlr-18810	679	5	that	that	SCONJ
ihlr-18810	679	6	charging	charge	VERB
ihlr-18810	679	7	another	another	DET
ihlr-18810	679	8	office	office	NOUN
ihlr-18810	679	9	or	or	CCONJ
ihlr-18810	679	10	agency	agency	NOUN
ihlr-18810	679	11	of	of	ADP
ihlr-18810	679	12	the	the	DET
ihlr-18810	679	13	government	government	NOUN
ihlr-18810	679	14	with	with	ADP
ihlr-18810	679	15	analyzing	analyze	VERB
ihlr-18810	679	16	clinical	clinical	ADJ
ihlr-18810	679	17	effectiveness	effectiveness	NOUN
ihlr-18810	679	18	research	research	NOUN
ihlr-18810	679	19	of	of	ADP
ihlr-18810	679	20	medical	medical	ADJ
ihlr-18810	679	21	devices	device	NOUN
ihlr-18810	679	22	and	and	CCONJ
ihlr-18810	679	23	arriving	arrive	VERB
ihlr-18810	679	24	at	at	ADP
ihlr-18810	679	25	comparative	comparative	ADJ
ihlr-18810	679	26	effectiveness	effectiveness	NOUN
ihlr-18810	679	27	determinations	determination	NOUN
ihlr-18810	679	28	will	will	AUX
ihlr-18810	679	29	be	be	AUX
ihlr-18810	679	30	an	an	DET
ihlr-18810	679	31	affordable	affordable	ADJ
ihlr-18810	679	32	alternative	alternative	ADJ
ihlr-18810	679	33	way	way	NOUN
ihlr-18810	679	34	to	to	PART
ihlr-18810	679	35	ensure	ensure	VERB
ihlr-18810	679	36	adequate	adequate	ADJ
ihlr-18810	679	37	post	post	ADJ
ihlr-18810	679	38	-	-	ADJ
ihlr-18810	679	39	market	market	ADJ
ihlr-18810	679	40	surveillance	surveillance	NOUN
ihlr-18810	679	41	of	of	ADP
ihlr-18810	679	42	510(k	510(k	PROPN
ihlr-18810	679	43	)	)	PUNCT
ihlr-18810	679	44	cleared	clear	VERB
ihlr-18810	679	45	devices	device	NOUN
ihlr-18810	679	46	,	,	PUNCT
ihlr-18810	679	47	while	while	SCONJ
ihlr-18810	679	48	also	also	ADV
ihlr-18810	679	49	alleviating	alleviate	VERB
ihlr-18810	679	50	the	the	DET
ihlr-18810	679	51	burdens	burden	NOUN
ihlr-18810	679	52	the	the	DET
ihlr-18810	679	53	fda	fda	PROPN
ihlr-18810	679	54	already	already	ADV
ihlr-18810	679	55	faces	face	VERB
ihlr-18810	679	56	in	in	ADP
ihlr-18810	679	57	carrying	carry	VERB
ihlr-18810	679	58	out	out	ADP
ihlr-18810	679	59	its	its	PRON
ihlr-18810	679	60	other	other	ADJ
ihlr-18810	679	61	duties	duty	NOUN
ihlr-18810	679	62	.	.	PUNCT
ihlr-18810	680	1	furthermore	furthermore	ADV
ihlr-18810	680	2	,	,	PUNCT
ihlr-18810	680	3	this	this	PRON
ihlr-18810	680	4	will	will	AUX
ihlr-18810	680	5	provide	provide	VERB
ihlr-18810	680	6	additional	additional	ADJ
ihlr-18810	680	7	incentives	incentive	NOUN
ihlr-18810	680	8	for	for	SCONJ
ihlr-18810	680	9	the	the	DET
ihlr-18810	680	10	medical	medical	ADJ
ihlr-18810	680	11	device	device	NOUN
ihlr-18810	680	12	industry	industry	NOUN
ihlr-18810	680	13	to	to	PART
ihlr-18810	680	14	comply	comply	VERB
ihlr-18810	680	15	with	with	ADP
ihlr-18810	680	16	federal	federal	ADJ
ihlr-18810	680	17	regulations	regulation	NOUN
ihlr-18810	680	18	,	,	PUNCT
ihlr-18810	680	19	which	which	PRON
ihlr-18810	680	20	could	could	AUX
ihlr-18810	680	21	potentially	potentially	ADV
ihlr-18810	680	22	improve	improve	VERB
ihlr-18810	680	23	compliance	compliance	NOUN
ihlr-18810	680	24	even	even	ADV
ihlr-18810	680	25	in	in	ADP
ihlr-18810	680	26	light	light	NOUN
ihlr-18810	680	27	of	of	ADP
ihlr-18810	680	28	the	the	DET
ihlr-18810	680	29	fda	fda	PROPN
ihlr-18810	680	30	's	's	PART
ihlr-18810	680	31	budgetary	budgetary	ADJ
ihlr-18810	680	32	constraints	constraint	NOUN
ihlr-18810	680	33	and	and	CCONJ
ihlr-18810	680	34	the	the	DET
ihlr-18810	680	35	recent	recent	ADJ
ihlr-18810	680	36	reduction	reduction	NOUN
ihlr-18810	680	37	in	in	ADP
ihlr-18810	680	38	fda	fda	PROPN
ihlr-18810	680	39	enforcement	enforcement	NOUN
ihlr-18810	680	40	actions	action	NOUN
ihlr-18810	680	41	.	.	PUNCT
ihlr-18810	680	42	271	271	NUM
ihlr-18810	680	43	however	however	ADV
ihlr-18810	680	44	,	,	PUNCT
ihlr-18810	680	45	providers	provider	NOUN
ihlr-18810	680	46	and	and	CCONJ
ihlr-18810	680	47	patients	patient	NOUN
ihlr-18810	680	48	alike	alike	ADV
ihlr-18810	680	49	expressed	express	VERB
ihlr-18810	680	50	concern	concern	NOUN
ihlr-18810	680	51	that	that	SCONJ
ihlr-18810	680	52	the	the	DET
ihlr-18810	680	53	information	information	NOUN
ihlr-18810	680	54	gained	gain	VERB
ihlr-18810	680	55	from	from	ADP
ihlr-18810	680	56	cer	cer	PROPN
ihlr-18810	680	57	would	would	AUX
ihlr-18810	680	58	be	be	AUX
ihlr-18810	680	59	used	use	VERB
ihlr-18810	680	60	to	to	PART
ihlr-18810	680	61	limit	limit	VERB
ihlr-18810	680	62	and	and	CCONJ
ihlr-18810	680	63	deny	deny	VERB
ihlr-18810	680	64	coverage	coverage	NOUN
ihlr-18810	680	65	to	to	ADP
ihlr-18810	680	66	patients	patient	NOUN
ihlr-18810	680	67	who	who	PRON
ihlr-18810	680	68	value	value	VERB
ihlr-18810	680	69	the	the	DET
ihlr-18810	680	70	tradeoff	tradeoff	NOUN
ihlr-18810	680	71	between	between	ADP
ihlr-18810	680	72	extending	extend	VERB
ihlr-18810	680	73	their	their	PRON
ihlr-18810	680	74	life	life	NOUN
ihlr-18810	680	75	and	and	CCONJ
ihlr-18810	680	76	the	the	DET
ihlr-18810	680	77	risk	risk	NOUN
ihlr-18810	680	78	of	of	ADP
ihlr-18810	680	79	disability	disability	NOUN
ihlr-18810	680	80	differently	differently	ADV
ihlr-18810	680	81	than	than	SCONJ
ihlr-18810	680	82	the	the	DET
ihlr-18810	680	83	government	government	NOUN
ihlr-18810	680	84	might	might	AUX
ihlr-18810	680	85	.	.	PUNCT
ihlr-18810	681	1	consequently	consequently	ADV
ihlr-18810	681	2	,	,	PUNCT
ihlr-18810	681	3	the	the	DET
ihlr-18810	681	4	aca	aca	PROPN
ihlr-18810	681	5	,	,	PUNCT
ihlr-18810	681	6	in	in	ADP
ihlr-18810	681	7	an	an	DET
ihlr-18810	681	8	effort	effort	NOUN
ihlr-18810	681	9	to	to	PART
ihlr-18810	681	10	alleviate	alleviate	VERB
ihlr-18810	681	11	these	these	DET
ihlr-18810	681	12	fears	fear	NOUN
ihlr-18810	681	13	,	,	PUNCT
ihlr-18810	681	14	expressly	expressly	ADV
ihlr-18810	681	15	prohibited	prohibit	VERB
ihlr-18810	681	16	the	the	DET
ihlr-18810	681	17	use	use	NOUN
ihlr-18810	681	18	of	of	ADP
ihlr-18810	681	19	cer	cer	PROPN
ihlr-18810	681	20	findings	finding	NOUN
ihlr-18810	681	21	to	to	PART
ihlr-18810	681	22	discourage	discourage	VERB
ihlr-18810	681	23	anyone	anyone	PRON
ihlr-18810	681	24	from	from	ADP
ihlr-18810	681	25	choosing	choose	VERB
ihlr-18810	681	26	a	a	DET
ihlr-18810	681	27	particular	particular	ADJ
ihlr-18810	681	28	treatment	treatment	NOUN
ihlr-18810	681	29	or	or	CCONJ
ihlr-18810	681	30	therapy.272	therapy.272	VERB
ihlr-18810	681	31	267	267	NUM
ihlr-18810	681	32	chalkidou	chalkidou	NOUN
ihlr-18810	681	33	,	,	PUNCT
ihlr-18810	681	34	supra	supra	PROPN
ihlr-18810	681	35	note	note	PROPN
ihlr-18810	681	36	262	262	NUM
ihlr-18810	681	37	,	,	PUNCT
ihlr-18810	681	38	at	at	ADP
ihlr-18810	681	39	4	4	NUM
ihlr-18810	681	40	.	.	NOUN
ihlr-18810	681	41	268	268	NUM
ihlr-18810	682	1	i	i	PRON
ihlr-18810	682	2	d.	d.	VERB
ihlr-18810	682	3	at	at	ADP
ihlr-18810	682	4	3	3	NUM
ihlr-18810	682	5	.	.	NUM
ihlr-18810	682	6	269	269	NUM
ihlr-18810	683	1	i	i	PRON
ihlr-18810	683	2	d.	d.	NOUN
ihlr-18810	683	3	270	270	NUM
ihlr-18810	684	1	i	i	PROPN
ihlr-18810	684	2	d.	d.	PROPN
ihlr-18810	684	3	271	271	NUM
ihlr-18810	684	4	see	see	VERB
ihlr-18810	684	5	decline	decline	NOUN
ihlr-18810	684	6	in	in	ADP
ihlr-18810	684	7	enforcement	enforcement	NOUN
ihlr-18810	684	8	,	,	PUNCT
ihlr-18810	684	9	supra	supra	PROPN
ihlr-18810	684	10	note	note	NOUN
ihlr-18810	684	11	167	167	NUM
ihlr-18810	684	12	,	,	PUNCT
ihlr-18810	684	13	at	at	ADP
ihlr-18810	684	14	i.	i.	PROPN
ihlr-18810	684	15	272	272	NUM
ihlr-18810	684	16	patient	patient	ADJ
ihlr-18810	684	17	protection	protection	NOUN
ihlr-18810	684	18	and	and	CCONJ
ihlr-18810	684	19	affordable	affordable	ADJ
ihlr-18810	684	20	care	care	PROPN
ihlr-18810	684	21	act	act	PROPN
ihlr-18810	684	22	,	,	PUNCT
ihlr-18810	684	23	pub	pub	NOUN
ihlr-18810	684	24	.	.	PUNCT
ihlr-18810	685	1	l.	l.	PROPN
ihlr-18810	685	2	no	no	INTJ
ihlr-18810	685	3	.	.	NOUN
ihlr-18810	686	1	111	111	NUM
ihlr-18810	686	2	-	-	SYM
ihlr-18810	686	3	148	148	NUM
ihlr-18810	686	4	,	,	PUNCT
ihlr-18810	686	5	§	§	PROPN
ihlr-18810	686	6	1182(d	1182(d	PROPN
ihlr-18810	686	7	)	)	PUNCT
ihlr-18810	686	8	,	,	PUNCT
ihlr-18810	686	9	42	42	NUM
ihlr-18810	686	10	u.s.c	u.s.c	ADJ
ihlr-18810	686	11	.	.	PUNCT
ihlr-18810	687	1	§	§	PROPN
ihlr-18810	687	2	1320(e)(1	1320(e)(1	NUM
ihlr-18810	687	3	)	)	PUNCT
ihlr-18810	687	4	(	(	PUNCT
ihlr-18810	687	5	2010	2010	NUM
ihlr-18810	687	6	)	)	PUNCT
ihlr-18810	687	7	.	.	PUNCT
ihlr-18810	688	1	2013	2013	NUM
ihlr-18810	688	2	163	163	NUM
ihlr-18810	688	3	indiana	indiana	PROPN
ihlr-18810	688	4	health	health	PROPN
ihlr-18810	688	5	law	law	PROPN
ihlr-18810	688	6	review	review	NOUN
ihlr-18810	688	7	specifically	specifically	ADV
ihlr-18810	688	8	,	,	PUNCT
ihlr-18810	688	9	the	the	DET
ihlr-18810	688	10	aca	aca	PROPN
ihlr-18810	688	11	states	state	VERB
ihlr-18810	688	12	:	:	PUNCT
ihlr-18810	688	13	(	(	PUNCT
ihlr-18810	688	14	d)(1	d)(1	X
ihlr-18810	688	15	)	)	PUNCT
ihlr-18810	688	16	the	the	DET
ihlr-18810	688	17	secretary	secretary	NOUN
ihlr-18810	688	18	shall	shall	AUX
ihlr-18810	688	19	not	not	PART
ihlr-18810	688	20	use	use	VERB
ihlr-18810	688	21	evidence	evidence	NOUN
ihlr-18810	688	22	or	or	CCONJ
ihlr-18810	688	23	findings	finding	NOUN
ihlr-18810	688	24	from	from	ADP
ihlr-18810	688	25	comparative	comparative	ADJ
ihlr-18810	688	26	clinical	clinical	ADJ
ihlr-18810	688	27	effectiveness	effectiveness	NOUN
ihlr-18810	688	28	research	research	NOUN
ihlr-18810	688	29	conducted	conduct	VERB
ihlr-18810	688	30	under	under	ADP
ihlr-18810	688	31	section	section	NOUN
ihlr-18810	688	32	1181	1181	NUM
ihlr-18810	688	33	in	in	ADP
ihlr-18810	688	34	determining	determine	VERB
ihlr-18810	688	35	coverage	coverage	NOUN
ihlr-18810	688	36	,	,	PUNCT
ihlr-18810	688	37	reimbursement	reimbursement	NOUN
ihlr-18810	688	38	,	,	PUNCT
ihlr-18810	688	39	or	or	CCONJ
ihlr-18810	688	40	incentive	incentive	NOUN
ihlr-18810	688	41	programs	program	NOUN
ihlr-18810	688	42	under	under	ADP
ihlr-18810	688	43	title	title	NOUN
ihlr-18810	688	44	xviii	xviii	NOUN
ihlr-18810	688	45	in	in	ADP
ihlr-18810	688	46	a	a	DET
ihlr-18810	688	47	manner	manner	NOUN
ihlr-18810	688	48	that	that	PRON
ihlr-18810	688	49	precludes	preclude	VERB
ihlr-18810	688	50	,	,	PUNCT
ihlr-18810	688	51	or	or	CCONJ
ihlr-18810	688	52	with	with	ADP
ihlr-18810	688	53	the	the	DET
ihlr-18810	688	54	intent	intent	NOUN
ihlr-18810	688	55	to	to	PART
ihlr-18810	688	56	discourage	discourage	VERB
ihlr-18810	688	57	,	,	PUNCT
ihlr-18810	688	58	an	an	DET
ihlr-18810	688	59	individual	individual	NOUN
ihlr-18810	688	60	from	from	ADP
ihlr-18810	688	61	choosing	choose	VERB
ihlr-18810	688	62	a	a	DET
ihlr-18810	688	63	health	health	NOUN
ihlr-18810	688	64	care	care	NOUN
ihlr-18810	688	65	treatment	treatment	NOUN
ihlr-18810	688	66	based	base	VERB
ihlr-18810	688	67	on	on	ADP
ihlr-18810	688	68	how	how	SCONJ
ihlr-18810	688	69	the	the	DET
ihlr-18810	688	70	individual	individual	ADJ
ihlr-18810	688	71	values	value	VERB
ihlr-18810	688	72	the	the	DET
ihlr-18810	688	73	tradeoff	tradeoff	NOUN
ihlr-18810	688	74	between	between	ADP
ihlr-18810	688	75	extending	extend	VERB
ihlr-18810	688	76	the	the	DET
ihlr-18810	688	77	length	length	NOUN
ihlr-18810	688	78	of	of	ADP
ihlr-18810	688	79	their	their	PRON
ihlr-18810	688	80	life	life	NOUN
ihlr-18810	688	81	and	and	CCONJ
ihlr-18810	688	82	the	the	DET
ihlr-18810	688	83	risk	risk	NOUN
ihlr-18810	688	84	of	of	ADP
ihlr-18810	688	85	disability	disability	NOUN
ihlr-18810	688	86	.	.	PUNCT
ihlr-18810	689	1	(	(	PUNCT
ihlr-18810	689	2	2)(a	2)(a	NOUN
ihlr-18810	689	3	)	)	PUNCT
ihlr-18810	689	4	paragraph	paragraph	NOUN
ihlr-18810	689	5	(	(	PUNCT
ihlr-18810	689	6	1	1	X
ihlr-18810	689	7	)	)	PUNCT
ihlr-18810	689	8	shall	shall	AUX
ihlr-18810	689	9	not	not	PART
ihlr-18810	689	10	be	be	AUX
ihlr-18810	689	11	construed	construe	VERB
ihlr-18810	689	12	to(i	to(i	PUNCT
ihlr-18810	689	13	)	)	PUNCT
ihlr-18810	689	14	limit	limit	VERB
ihlr-18810	689	15	the	the	DET
ihlr-18810	689	16	application	application	NOUN
ihlr-18810	689	17	of	of	ADP
ihlr-18810	689	18	differential	differential	ADJ
ihlr-18810	689	19	copayments	copayment	NOUN
ihlr-18810	689	20	under	under	ADP
ihlr-18810	689	21	title	title	NOUN
ihlr-18810	689	22	xviii	xviii	PROPN
ihlr-18810	689	23	based	base	VERB
ihlr-18810	689	24	on	on	ADP
ihlr-18810	689	25	factors	factor	NOUN
ihlr-18810	689	26	such	such	ADJ
ihlr-18810	689	27	as	as	ADP
ihlr-18810	689	28	cost	cost	NOUN
ihlr-18810	689	29	or	or	CCONJ
ihlr-18810	689	30	type	type	NOUN
ihlr-18810	689	31	of	of	ADP
ihlr-18810	689	32	service	service	NOUN
ihlr-18810	689	33	;	;	PUNCT
ihlr-18810	689	34	or	or	CCONJ
ihlr-18810	689	35	(	(	PUNCT
ihlr-18810	689	36	ii	ii	NOUN
ihlr-18810	689	37	)	)	PUNCT
ihlr-18810	689	38	prevent	prevent	VERB
ihlr-18810	689	39	the	the	DET
ihlr-18810	689	40	secretary	secretary	NOUN
ihlr-18810	689	41	from	from	ADP
ihlr-18810	689	42	using	use	VERB
ihlr-18810	689	43	evidence	evidence	NOUN
ihlr-18810	689	44	or	or	CCONJ
ihlr-18810	689	45	findings	finding	NOUN
ihlr-18810	689	46	from	from	ADP
ihlr-18810	689	47	such	such	ADJ
ihlr-18810	689	48	comparative	comparative	ADJ
ihlr-18810	689	49	clinical	clinical	ADJ
ihlr-18810	689	50	effectiveness	effectiveness	NOUN
ihlr-18810	689	51	research	research	NOUN
ihlr-18810	689	52	in	in	ADP
ihlr-18810	689	53	determining	determine	VERB
ihlr-18810	689	54	coverage	coverage	NOUN
ihlr-18810	689	55	,	,	PUNCT
ihlr-18810	689	56	reimbursement	reimbursement	NOUN
ihlr-18810	689	57	,	,	PUNCT
ihlr-18810	689	58	or	or	CCONJ
ihlr-18810	689	59	incentive	incentive	NOUN
ihlr-18810	689	60	programs	program	NOUN
ihlr-18810	689	61	under	under	ADP
ihlr-18810	689	62	such	such	ADJ
ihlr-18810	689	63	title	title	NOUN
ihlr-18810	689	64	based	base	VERB
ihlr-18810	689	65	upon	upon	SCONJ
ihlr-18810	689	66	a	a	DET
ihlr-18810	689	67	comparison	comparison	NOUN
ihlr-18810	689	68	of	of	ADP
ihlr-18810	689	69	the	the	DET
ihlr-18810	689	70	difference	difference	NOUN
ihlr-18810	689	71	in	in	ADP
ihlr-18810	689	72	the	the	DET
ihlr-18810	689	73	effectiveness	effectiveness	NOUN
ihlr-18810	689	74	of	of	ADP
ihlr-18810	689	75	alternative	alternative	ADJ
ihlr-18810	689	76	health	health	NOUN
ihlr-18810	689	77	care	care	NOUN
ihlr-18810	689	78	treatments	treatment	NOUN
ihlr-18810	689	79	in	in	ADP
ihlr-18810	689	80	extending	extend	VERB
ihlr-18810	689	81	an	an	DET
ihlr-18810	689	82	individual	individual	NOUN
ihlr-18810	689	83	's	's	PART
ihlr-18810	689	84	life	life	NOUN
ihlr-18810	689	85	due	due	ADP
ihlr-18810	689	86	to	to	ADP
ihlr-18810	689	87	that	that	DET
ihlr-18810	689	88	individual	individual	NOUN
ihlr-18810	689	89	's	's	PART
ihlr-18810	689	90	age	age	NOUN
ihlr-18810	689	91	,	,	PUNCT
ihlr-18810	689	92	disability	disability	NOUN
ihlr-18810	689	93	,	,	PUNCT
ihlr-18810	689	94	or	or	CCONJ
ihlr-18810	689	95	terminal	terminal	ADJ
ihlr-18810	689	96	illness	illness	NOUN
ihlr-18810	689	97	.	.	PUNCT
ihlr-18810	690	1	273	273	NUM
ihlr-18810	690	2	the	the	DET
ihlr-18810	690	3	best	good	ADJ
ihlr-18810	690	4	way	way	NOUN
ihlr-18810	690	5	to	to	PART
ihlr-18810	690	6	ensure	ensure	VERB
ihlr-18810	690	7	that	that	SCONJ
ihlr-18810	690	8	patients	patient	NOUN
ihlr-18810	690	9	receive	receive	VERB
ihlr-18810	690	10	the	the	DET
ihlr-18810	690	11	best	good	ADJ
ihlr-18810	690	12	possible	possible	ADJ
ihlr-18810	690	13	care	care	NOUN
ihlr-18810	690	14	,	,	PUNCT
ihlr-18810	690	15	and	and	CCONJ
ihlr-18810	690	16	the	the	DET
ihlr-18810	690	17	most	most	ADV
ihlr-18810	690	18	effective	effective	ADJ
ihlr-18810	690	19	way	way	NOUN
ihlr-18810	690	20	to	to	PART
ihlr-18810	690	21	ensure	ensure	VERB
ihlr-18810	690	22	the	the	DET
ihlr-18810	690	23	safety	safety	NOUN
ihlr-18810	690	24	and	and	CCONJ
ihlr-18810	690	25	effectiveness	effectiveness	NOUN
ihlr-18810	690	26	of	of	ADP
ihlr-18810	690	27	devices	device	NOUN
ihlr-18810	690	28	cleared	clear	VERB
ihlr-18810	690	29	through	through	ADP
ihlr-18810	690	30	the	the	DET
ihlr-18810	690	31	510(k	510(k	PROPN
ihlr-18810	690	32	)	)	PUNCT
ihlr-18810	690	33	process	process	NOUN
ihlr-18810	690	34	,	,	PUNCT
ihlr-18810	690	35	however	however	ADV
ihlr-18810	690	36	,	,	PUNCT
ihlr-18810	690	37	is	be	AUX
ihlr-18810	690	38	to	to	PART
ihlr-18810	690	39	enable	enable	VERB
ihlr-18810	690	40	the	the	DET
ihlr-18810	690	41	government	government	NOUN
ihlr-18810	690	42	to	to	PART
ihlr-18810	690	43	make	make	VERB
ihlr-18810	690	44	use	use	NOUN
ihlr-18810	690	45	of	of	ADP
ihlr-18810	690	46	comparative	comparative	ADJ
ihlr-18810	690	47	effectiveness	effectiveness	NOUN
ihlr-18810	690	48	information	information	NOUN
ihlr-18810	690	49	in	in	ADP
ihlr-18810	690	50	their	their	PRON
ihlr-18810	690	51	coverage	coverage	NOUN
ihlr-18810	690	52	decisions	decision	NOUN
ihlr-18810	690	53	just	just	ADV
ihlr-18810	690	54	as	as	SCONJ
ihlr-18810	690	55	private	private	ADJ
ihlr-18810	690	56	insurers	insurer	NOUN
ihlr-18810	690	57	do	do	VERB
ihlr-18810	690	58	,	,	PUNCT
ihlr-18810	690	59	and	and	CCONJ
ihlr-18810	690	60	consequently	consequently	ADV
ihlr-18810	690	61	,	,	PUNCT
ihlr-18810	690	62	the	the	DET
ihlr-18810	690	63	prohibition	prohibition	NOUN
ihlr-18810	690	64	on	on	ADP
ihlr-18810	690	65	the	the	DET
ihlr-18810	690	66	use	use	NOUN
ihlr-18810	690	67	of	of	ADP
ihlr-18810	690	68	this	this	DET
ihlr-18810	690	69	information	information	NOUN
ihlr-18810	690	70	in	in	ADP
ihlr-18810	690	71	coverage	coverage	NOUN
ihlr-18810	690	72	decisions	decision	NOUN
ihlr-18810	690	73	should	should	AUX
ihlr-18810	690	74	be	be	AUX
ihlr-18810	690	75	lifted	lift	VERB
ihlr-18810	690	76	.	.	PUNCT
ihlr-18810	691	1	concerns	concern	NOUN
ihlr-18810	691	2	have	have	AUX
ihlr-18810	691	3	been	be	AUX
ihlr-18810	691	4	raised	raise	VERB
ihlr-18810	691	5	that	that	SCONJ
ihlr-18810	691	6	the	the	DET
ihlr-18810	691	7	use	use	NOUN
ihlr-18810	691	8	of	of	ADP
ihlr-18810	691	9	cer	cer	NOUN
ihlr-18810	691	10	to	to	ADP
ihlr-18810	691	11	273	273	NUM
ihlr-18810	691	12	42	42	NUM
ihlr-18810	691	13	u.s.c	u.s.c	ADJ
ihlr-18810	691	14	.	.	PUNCT
ihlr-18810	692	1	§	§	PROPN
ihlr-18810	692	2	1320(e)(1	1320(e)(1	NUM
ihlr-18810	692	3	)	)	PUNCT
ihlr-18810	692	4	.	.	PUNCT
ihlr-18810	693	1	vol	vol	NOUN
ihlr-18810	693	2	.	.	PUNCT
ihlr-18810	694	1	10:1164	10:1164	NOUN
ihlr-18810	694	2	510(k	510(k	NUM
ihlr-18810	694	3	)	)	PUNCT
ihlr-18810	694	4	clearance	clearance	NOUN
ihlr-18810	694	5	deny	deny	NOUN
ihlr-18810	694	6	coverage	coverage	NOUN
ihlr-18810	694	7	will	will	AUX
ihlr-18810	694	8	open	open	VERB
ihlr-18810	694	9	the	the	DET
ihlr-18810	694	10	doors	door	NOUN
ihlr-18810	694	11	to	to	ADP
ihlr-18810	694	12	the	the	DET
ihlr-18810	694	13	making	making	NOUN
ihlr-18810	694	14	of	of	ADP
ihlr-18810	694	15	coverage	coverage	NOUN
ihlr-18810	694	16	decisions	decision	NOUN
ihlr-18810	694	17	not	not	PART
ihlr-18810	694	18	on	on	ADP
ihlr-18810	694	19	the	the	DET
ihlr-18810	694	20	patient	patient	NOUN
ihlr-18810	694	21	's	's	PART
ihlr-18810	694	22	health	health	NOUN
ihlr-18810	694	23	outcome	outcome	NOUN
ihlr-18810	694	24	,	,	PUNCT
ihlr-18810	694	25	but	but	CCONJ
ihlr-18810	694	26	on	on	ADP
ihlr-18810	694	27	the	the	DET
ihlr-18810	694	28	perceived	perceive	VERB
ihlr-18810	694	29	value	value	NOUN
ihlr-18810	694	30	to	to	ADP
ihlr-18810	694	31	society	society	NOUN
ihlr-18810	694	32	of	of	ADP
ihlr-18810	694	33	the	the	DET
ihlr-18810	694	34	healthcare	healthcare	NOUN
ihlr-18810	694	35	dollars	dollar	NOUN
ihlr-18810	694	36	spent	spend	VERB
ihlr-18810	694	37	,	,	PUNCT
ihlr-18810	694	38	as	as	SCONJ
ihlr-18810	694	39	measured	measure	VERB
ihlr-18810	694	40	by	by	ADP
ihlr-18810	694	41	the	the	DET
ihlr-18810	694	42	patient	patient	NOUN
ihlr-18810	694	43	's	's	PART
ihlr-18810	694	44	anticipated	anticipate	VERB
ihlr-18810	694	45	subsequent	subsequent	ADJ
ihlr-18810	694	46	level	level	NOUN
ihlr-18810	694	47	of	of	ADP
ihlr-18810	694	48	productivity	productivity	NOUN
ihlr-18810	694	49	in	in	ADP
ihlr-18810	694	50	society.274	society.274	ADJ
ihlr-18810	694	51	arguments	argument	NOUN
ihlr-18810	694	52	supporting	support	VERB
ihlr-18810	694	53	cer	cer	NOUN
ihlr-18810	694	54	point	point	VERB
ihlr-18810	694	55	out	out	ADP
ihlr-18810	694	56	that	that	SCONJ
ihlr-18810	694	57	true	true	ADJ
ihlr-18810	694	58	healthcare	healthcare	NOUN
ihlr-18810	694	59	savings	saving	NOUN
ihlr-18810	694	60	will	will	AUX
ihlr-18810	694	61	result	result	VERB
ihlr-18810	694	62	from	from	ADP
ihlr-18810	694	63	changing	change	VERB
ihlr-18810	694	64	how	how	SCONJ
ihlr-18810	694	65	doctors	doctor	NOUN
ihlr-18810	694	66	think	think	VERB
ihlr-18810	694	67	about	about	ADP
ihlr-18810	694	68	healthcare	healthcare	NOUN
ihlr-18810	694	69	,	,	PUNCT
ihlr-18810	694	70	275	275	NUM
ihlr-18810	694	71	and	and	CCONJ
ihlr-18810	694	72	remembering	remember	VERB
ihlr-18810	694	73	that	that	SCONJ
ihlr-18810	694	74	providing	provide	VERB
ihlr-18810	694	75	all	all	DET
ihlr-18810	694	76	available	available	ADJ
ihlr-18810	694	77	treatments	treatment	NOUN
ihlr-18810	694	78	is	be	AUX
ihlr-18810	694	79	not	not	PART
ihlr-18810	694	80	necessarily	necessarily	ADV
ihlr-18810	694	81	in	in	ADP
ihlr-18810	694	82	the	the	DET
ihlr-18810	694	83	patient	patient	NOUN
ihlr-18810	694	84	's	's	PART
ihlr-18810	694	85	best	good	ADJ
ihlr-18810	694	86	interest	interest	NOUN
ihlr-18810	694	87	nor	nor	CCONJ
ihlr-18810	694	88	will	will	AUX
ihlr-18810	694	89	it	it	PRON
ihlr-18810	694	90	necessarily	necessarily	ADV
ihlr-18810	694	91	lead	lead	VERB
ihlr-18810	694	92	to	to	ADP
ihlr-18810	694	93	the	the	DET
ihlr-18810	694	94	best	good	ADJ
ihlr-18810	694	95	patient	patient	ADJ
ihlr-18810	694	96	outcome	outcome	NOUN
ihlr-18810	694	97	.	.	PUNCT
ihlr-18810	695	1	these	these	DET
ihlr-18810	695	2	arguments	argument	NOUN
ihlr-18810	695	3	,	,	PUNCT
ihlr-18810	695	4	however	however	ADV
ihlr-18810	695	5	,	,	PUNCT
ihlr-18810	695	6	have	have	AUX
ihlr-18810	695	7	been	be	AUX
ihlr-18810	695	8	met	meet	VERB
ihlr-18810	695	9	with	with	ADP
ihlr-18810	695	10	opposition	opposition	NOUN
ihlr-18810	695	11	fueled	fuel	VERB
ihlr-18810	695	12	by	by	ADP
ihlr-18810	695	13	the	the	DET
ihlr-18810	695	14	fear	fear	NOUN
ihlr-18810	695	15	that	that	SCONJ
ihlr-18810	695	16	the	the	DET
ihlr-18810	695	17	result	result	NOUN
ihlr-18810	695	18	will	will	AUX
ihlr-18810	695	19	be	be	AUX
ihlr-18810	695	20	the	the	DET
ihlr-18810	695	21	denial	denial	NOUN
ihlr-18810	695	22	of	of	ADP
ihlr-18810	695	23	care	care	NOUN
ihlr-18810	695	24	to	to	ADP
ihlr-18810	695	25	elderly	elderly	ADJ
ihlr-18810	695	26	or	or	CCONJ
ihlr-18810	695	27	disabled	disabled	ADJ
ihlr-18810	695	28	patients	patient	NOUN
ihlr-18810	695	29	,	,	PUNCT
ihlr-18810	695	30	and	and	CCONJ
ihlr-18810	695	31	patients	patient	NOUN
ihlr-18810	695	32	will	will	AUX
ihlr-18810	695	33	be	be	AUX
ihlr-18810	695	34	discriminated	discriminate	VERB
ihlr-18810	695	35	against	against	ADP
ihlr-18810	695	36	in	in	ADP
ihlr-18810	695	37	the	the	DET
ihlr-18810	695	38	provision	provision	NOUN
ihlr-18810	695	39	of	of	ADP
ihlr-18810	695	40	274	274	NUM
ihlr-18810	695	41	sarah	sarah	PROPN
ihlr-18810	695	42	palin	palin	PROPN
ihlr-18810	695	43	,	,	PUNCT
ihlr-18810	695	44	statement	statement	NOUN
ihlr-18810	695	45	on	on	ADP
ihlr-18810	695	46	the	the	DET
ihlr-18810	695	47	current	current	ADJ
ihlr-18810	695	48	healthcare	healthcare	NOUN
ihlr-18810	695	49	debate	debate	NOUN
ihlr-18810	695	50	,	,	PUNCT
ihlr-18810	695	51	facebook	facebook	PROPN
ihlr-18810	695	52	(	(	PUNCT
ihlr-18810	695	53	aug	aug	PROPN
ihlr-18810	695	54	.	.	PROPN
ihlr-18810	695	55	7	7	NUM
ihlr-18810	695	56	,	,	PUNCT
ihlr-18810	695	57	2009	2009	NUM
ihlr-18810	695	58	)	)	PUNCT
ihlr-18810	695	59	,	,	PUNCT
ihlr-18810	695	60	https://www.facebook.com/note.php	https://www.facebook.com/note.php	PROPN
ihlr-18810	695	61	?	?	PUNCT
ihlr-18810	696	1	note_id=113851103434	note_id=113851103434	PROPN
ihlr-18810	696	2	(	(	PUNCT
ihlr-18810	696	3	"	"	PUNCT
ihlr-18810	696	4	the	the	DET
ihlr-18810	696	5	democrats	democrats	PROPN
ihlr-18810	696	6	promise	promise	VERB
ihlr-18810	696	7	that	that	SCONJ
ihlr-18810	696	8	a	a	DET
ihlr-18810	696	9	government	government	NOUN
ihlr-18810	696	10	health	health	NOUN
ihlr-18810	696	11	care	care	NOUN
ihlr-18810	696	12	system	system	NOUN
ihlr-18810	696	13	will	will	AUX
ihlr-18810	696	14	reduce	reduce	VERB
ihlr-18810	696	15	the	the	DET
ihlr-18810	696	16	cost	cost	NOUN
ihlr-18810	696	17	of	of	ADP
ihlr-18810	696	18	health	health	NOUN
ihlr-18810	696	19	care	care	NOUN
ihlr-18810	696	20	,	,	PUNCT
ihlr-18810	696	21	but	but	CCONJ
ihlr-18810	696	22	as	as	SCONJ
ihlr-18810	696	23	the	the	DET
ihlr-18810	696	24	economist	economist	NOUN
ihlr-18810	696	25	thomas	thomas	PROPN
ihlr-18810	696	26	sowell	sowell	PROPN
ihlr-18810	696	27	has	have	AUX
ihlr-18810	696	28	pointed	point	VERB
ihlr-18810	696	29	out	out	ADP
ihlr-18810	696	30	,	,	PUNCT
ihlr-18810	696	31	government	government	NOUN
ihlr-18810	696	32	health	health	NOUN
ihlr-18810	696	33	care	care	NOUN
ihlr-18810	696	34	will	will	AUX
ihlr-18810	696	35	not	not	PART
ihlr-18810	696	36	reduce	reduce	VERB
ihlr-18810	696	37	the	the	DET
ihlr-18810	696	38	cost	cost	NOUN
ihlr-18810	696	39	;	;	PUNCT
ihlr-18810	696	40	it	it	PRON
ihlr-18810	696	41	will	will	AUX
ihlr-18810	696	42	simply	simply	ADV
ihlr-18810	696	43	refuse	refuse	VERB
ihlr-18810	696	44	to	to	PART
ihlr-18810	696	45	pay	pay	VERB
ihlr-18810	696	46	the	the	DET
ihlr-18810	696	47	cost	cost	NOUN
ihlr-18810	696	48	.	.	PUNCT
ihlr-18810	697	1	and	and	CCONJ
ihlr-18810	697	2	who	who	PRON
ihlr-18810	697	3	will	will	AUX
ihlr-18810	697	4	suffer	suffer	VERB
ihlr-18810	697	5	the	the	DET
ihlr-18810	697	6	most	most	ADJ
ihlr-18810	697	7	when	when	SCONJ
ihlr-18810	697	8	they	they	PRON
ihlr-18810	697	9	ration	ration	VERB
ihlr-18810	697	10	care	care	VERB
ihlr-18810	697	11	?	?	PUNCT
ihlr-18810	698	1	the	the	DET
ihlr-18810	698	2	sick	sick	ADJ
ihlr-18810	698	3	,	,	PUNCT
ihlr-18810	698	4	the	the	DET
ihlr-18810	698	5	elderly	elderly	ADJ
ihlr-18810	698	6	,	,	PUNCT
ihlr-18810	698	7	and	and	CCONJ
ihlr-18810	698	8	the	the	DET
ihlr-18810	698	9	disabled	disabled	ADJ
ihlr-18810	698	10	,	,	PUNCT
ihlr-18810	698	11	of	of	ADP
ihlr-18810	698	12	course	course	NOUN
ihlr-18810	698	13	.	.	PUNCT
ihlr-18810	699	1	the	the	DET
ihlr-18810	699	2	america	america	PROPN
ihlr-18810	699	3	i	i	PRON
ihlr-18810	699	4	know	know	VERB
ihlr-18810	699	5	and	and	CCONJ
ihlr-18810	699	6	love	love	NOUN
ihlr-18810	699	7	is	be	AUX
ihlr-18810	699	8	not	not	PART
ihlr-18810	699	9	one	one	NUM
ihlr-18810	699	10	in	in	ADP
ihlr-18810	699	11	which	which	PRON
ihlr-18810	699	12	my	my	PRON
ihlr-18810	699	13	parents	parent	NOUN
ihlr-18810	699	14	or	or	CCONJ
ihlr-18810	699	15	my	my	PRON
ihlr-18810	699	16	baby	baby	NOUN
ihlr-18810	699	17	with	with	ADP
ihlr-18810	699	18	down	down	ADP
ihlr-18810	699	19	syndrome	syndrome	NOUN
ihlr-18810	699	20	will	will	AUX
ihlr-18810	699	21	have	have	VERB
ihlr-18810	699	22	to	to	PART
ihlr-18810	699	23	stand	stand	VERB
ihlr-18810	699	24	in	in	ADP
ihlr-18810	699	25	front	front	NOUN
ihlr-18810	699	26	of	of	ADP
ihlr-18810	699	27	obama	obama	NOUN
ihlr-18810	699	28	's	's	PART
ihlr-18810	699	29	'	'	PUNCT
ihlr-18810	699	30	death	death	NOUN
ihlr-18810	699	31	panel	panel	NOUN
ihlr-18810	699	32	'	'	PUNCT
ihlr-18810	699	33	so	so	SCONJ
ihlr-18810	699	34	his	his	PRON
ihlr-18810	699	35	bureaucrats	bureaucrat	NOUN
ihlr-18810	699	36	can	can	AUX
ihlr-18810	699	37	decide	decide	VERB
ihlr-18810	699	38	,	,	PUNCT
ihlr-18810	699	39	based	base	VERB
ihlr-18810	699	40	on	on	ADP
ihlr-18810	699	41	a	a	DET
ihlr-18810	699	42	subjective	subjective	ADJ
ihlr-18810	699	43	judgment	judgment	NOUN
ihlr-18810	699	44	of	of	ADP
ihlr-18810	699	45	their	their	PRON
ihlr-18810	699	46	'	'	PUNCT
ihlr-18810	699	47	level	level	NOUN
ihlr-18810	699	48	of	of	ADP
ihlr-18810	699	49	productivity	productivity	NOUN
ihlr-18810	699	50	in	in	ADP
ihlr-18810	699	51	society	society	NOUN
ihlr-18810	699	52	,	,	PUNCT
ihlr-18810	699	53	'	'	PUNCT
ihlr-18810	699	54	whether	whether	SCONJ
ihlr-18810	699	55	they	they	PRON
ihlr-18810	699	56	are	be	AUX
ihlr-18810	699	57	worthy	worthy	ADJ
ihlr-18810	699	58	of	of	ADP
ihlr-18810	699	59	health	health	NOUN
ihlr-18810	699	60	care	care	NOUN
ihlr-18810	699	61	.	.	PUNCT
ihlr-18810	700	1	such	such	DET
ihlr-18810	700	2	a	a	DET
ihlr-18810	700	3	system	system	NOUN
ihlr-18810	700	4	is	be	AUX
ihlr-18810	700	5	downright	downright	ADV
ihlr-18810	700	6	evil	evil	ADJ
ihlr-18810	700	7	.	.	PUNCT
ihlr-18810	701	1	"	"	PUNCT
ihlr-18810	701	2	)	)	PUNCT
ihlr-18810	701	3	.	.	PUNCT
ihlr-18810	702	1	275	275	NUM
ihlr-18810	702	2	see	see	VERB
ihlr-18810	702	3	,	,	PUNCT
ihlr-18810	702	4	e.g.	e.g.	ADV
ihlr-18810	702	5	,	,	PUNCT
ihlr-18810	702	6	ezekiel	ezekiel	PROPN
ihlr-18810	702	7	j.	j.	PROPN
ihlr-18810	702	8	emanuel	emanuel	PROPN
ihlr-18810	702	9	&	&	CCONJ
ihlr-18810	702	10	victor	victor	PROPN
ihlr-18810	702	11	r.	r.	PROPN
ihlr-18810	702	12	fuchs	fuchs	PROPN
ihlr-18810	702	13	,	,	PUNCT
ihlr-18810	702	14	the	the	DET
ihlr-18810	702	15	perfect	perfect	ADJ
ihlr-18810	702	16	storm	storm	NOUN
ihlr-18810	702	17	of	of	ADP
ihlr-18810	702	18	overutilization	overutilization	NOUN
ihlr-18810	702	19	,	,	PUNCT
ihlr-18810	702	20	299	299	NUM
ihlr-18810	702	21	jama	jama	NOUN
ihlr-18810	702	22	2789	2789	NUM
ihlr-18810	702	23	,	,	PUNCT
ihlr-18810	702	24	2790	2790	NUM
ihlr-18810	702	25	-	-	SYM
ihlr-18810	702	26	91	91	NUM
ihlr-18810	702	27	(	(	PUNCT
ihlr-18810	702	28	2008	2008	NUM
ihlr-18810	702	29	)	)	PUNCT
ihlr-18810	702	30	(	(	PUNCT
ihlr-18810	702	31	"	"	PUNCT
ihlr-18810	702	32	when	when	SCONJ
ihlr-18810	702	33	evaluating	evaluate	VERB
ihlr-18810	702	34	a	a	DET
ihlr-18810	702	35	patient	patient	NOUN
ihlr-18810	702	36	,	,	PUNCT
ihlr-18810	702	37	students	student	NOUN
ihlr-18810	702	38	,	,	PUNCT
ihlr-18810	702	39	interns	intern	NOUN
ihlr-18810	702	40	,	,	PUNCT
ihlr-18810	702	41	and	and	CCONJ
ihlr-18810	702	42	residents	resident	NOUN
ihlr-18810	702	43	are	be	AUX
ihlr-18810	702	44	trained	train	VERB
ihlr-18810	702	45	to	to	PART
ihlr-18810	702	46	identify	identify	VERB
ihlr-18810	702	47	and	and	CCONJ
ihlr-18810	702	48	praised	praise	VERB
ihlr-18810	702	49	for	for	ADP
ihlr-18810	702	50	and	and	CCONJ
ihlr-18810	702	51	graded	grade	VERB
ihlr-18810	702	52	on	on	ADP
ihlr-18810	702	53	enumerating	enumerate	VERB
ihlr-18810	702	54	all	all	DET
ihlr-18810	702	55	possible	possible	ADJ
ihlr-18810	702	56	diagnoses	diagnosis	NOUN
ihlr-18810	702	57	and	and	CCONJ
ihlr-18810	702	58	tests	test	NOUN
ihlr-18810	702	59	that	that	PRON
ihlr-18810	702	60	would	would	AUX
ihlr-18810	702	61	confirm	confirm	VERB
ihlr-18810	702	62	or	or	CCONJ
ihlr-18810	702	63	exclude	exclude	VERB
ihlr-18810	702	64	them	they	PRON
ihlr-18810	702	65	.	.	PUNCT
ihlr-18810	703	1	the	the	DET
ihlr-18810	703	2	thought	thought	NOUN
ihlr-18810	703	3	is	be	AUX
ihlr-18810	703	4	that	that	SCONJ
ihlr-18810	703	5	the	the	PRON
ihlr-18810	703	6	more	more	ADV
ihlr-18810	703	7	thorough	thorough	ADJ
ihlr-18810	703	8	the	the	DET
ihlr-18810	703	9	evaluation	evaluation	NOUN
ihlr-18810	703	10	,	,	PUNCT
ihlr-18810	703	11	the	the	DET
ihlr-18810	703	12	more	more	ADV
ihlr-18810	703	13	intelligent	intelligent	ADJ
ihlr-18810	703	14	the	the	DET
ihlr-18810	703	15	student	student	NOUN
ihlr-18810	703	16	or	or	CCONJ
ihlr-18810	703	17	house	house	NOUN
ihlr-18810	703	18	officer	officer	NOUN
ihlr-18810	703	19	.	.	PUNCT
ihlr-18810	704	1	trainees	trainee	NOUN
ihlr-18810	704	2	who	who	PRON
ihlr-18810	704	3	ignore	ignore	VERB
ihlr-18810	704	4	the	the	DET
ihlr-18810	704	5	improbable	improbable	ADJ
ihlr-18810	704	6	'	'	PUNCT
ihlr-18810	704	7	zebra	zebra	NOUN
ihlr-18810	704	8	'	'	PART
ihlr-18810	704	9	diagnoses	diagnosis	NOUN
ihlr-18810	704	10	are	be	AUX
ihlr-18810	704	11	not	not	PART
ihlr-18810	704	12	deemed	deem	VERB
ihlr-18810	704	13	insightful	insightful	ADJ
ihlr-18810	704	14	.	.	PUNCT
ihlr-18810	705	1	in	in	ADP
ihlr-18810	705	2	medical	medical	ADJ
ihlr-18810	705	3	training	training	NOUN
ihlr-18810	705	4	,	,	PUNCT
ihlr-18810	705	5	meticulousness	meticulousness	NOUN
ihlr-18810	705	6	,	,	PUNCT
ihlr-18810	705	7	not	not	PART
ihlr-18810	705	8	effectiveness	effectiveness	NOUN
ihlr-18810	705	9	,	,	PUNCT
ihlr-18810	705	10	is	be	AUX
ihlr-18810	705	11	rewarded	reward	VERB
ihlr-18810	705	12	.	.	PUNCT
ihlr-18810	706	1	this	this	DET
ihlr-18810	706	2	mentality	mentality	NOUN
ihlr-18810	706	3	carries	carry	VERB
ihlr-18810	706	4	over	over	ADP
ihlr-18810	706	5	into	into	ADP
ihlr-18810	706	6	practice	practice	NOUN
ihlr-18810	706	7	.	.	PUNCT
ihlr-18810	707	1	peer	peer	NOUN
ihlr-18810	707	2	recognition	recognition	NOUN
ihlr-18810	707	3	goes	go	VERB
ihlr-18810	707	4	to	to	ADP
ihlr-18810	707	5	the	the	DET
ihlr-18810	707	6	most	most	ADV
ihlr-18810	707	7	thorough	thorough	ADJ
ihlr-18810	707	8	and	and	CCONJ
ihlr-18810	707	9	aggressive	aggressive	ADJ
ihlr-18810	707	10	physicians	physician	NOUN
ihlr-18810	707	11	.	.	PUNCT
ihlr-18810	708	1	the	the	DET
ihlr-18810	708	2	prudent	prudent	ADJ
ihlr-18810	708	3	physician	physician	NOUN
ihlr-18810	708	4	is	be	AUX
ihlr-18810	708	5	not	not	PART
ihlr-18810	708	6	deemed	deem	VERB
ihlr-18810	708	7	particularly	particularly	ADV
ihlr-18810	708	8	competent	competent	ADJ
ihlr-18810	708	9	,	,	PUNCT
ihlr-18810	708	10	but	but	CCONJ
ihlr-18810	708	11	rather	rather	ADV
ihlr-18810	708	12	inadequate	inadequate	ADJ
ihlr-18810	708	13	.	.	PUNCT
ihlr-18810	709	1	this	this	DET
ihlr-18810	709	2	culture	culture	NOUN
ihlr-18810	709	3	is	be	AUX
ihlr-18810	709	4	further	far	ADV
ihlr-18810	709	5	reinforced	reinforce	VERB
ihlr-18810	709	6	by	by	ADP
ihlr-18810	709	7	a	a	DET
ihlr-18810	709	8	unique	unique	ADJ
ihlr-18810	709	9	understanding	understanding	NOUN
ihlr-18810	709	10	of	of	ADP
ihlr-18810	709	11	professional	professional	ADJ
ihlr-18810	709	12	obligations	obligation	NOUN
ihlr-18810	709	13	,	,	PUNCT
ihlr-18810	709	14	specifically	specifically	ADV
ihlr-18810	709	15	,	,	PUNCT
ihlr-18810	709	16	the	the	DET
ihlr-18810	709	17	hippocratic	hippocratic	ADJ
ihlr-18810	709	18	oath	oath	NOUN
ihlr-18810	709	19	's	's	PART
ihlr-18810	709	20	admonition	admonition	NOUN
ihlr-18810	709	21	to	to	PART
ihlr-18810	709	22	'	'	PUNCT
ihlr-18810	709	23	use	use	VERB
ihlr-18810	709	24	my	my	PRON
ihlr-18810	709	25	power	power	NOUN
ihlr-18810	709	26	to	to	PART
ihlr-18810	709	27	help	help	VERB
ihlr-18810	709	28	the	the	DET
ihlr-18810	709	29	sick	sick	ADJ
ihlr-18810	709	30	to	to	ADP
ihlr-18810	709	31	the	the	DET
ihlr-18810	709	32	best	good	ADJ
ihlr-18810	709	33	of	of	ADP
ihlr-18810	709	34	my	my	PRON
ihlr-18810	709	35	ability	ability	NOUN
ihlr-18810	709	36	and	and	CCONJ
ihlr-18810	709	37	judgment	judgment	NOUN
ihlr-18810	709	38	'	'	PUNCT
ihlr-18810	709	39	as	as	ADP
ihlr-18810	709	40	an	an	DET
ihlr-18810	709	41	imperative	imperative	NOUN
ihlr-18810	709	42	to	to	PART
ihlr-18810	709	43	do	do	VERB
ihlr-18810	709	44	everything	everything	PRON
ihlr-18810	709	45	for	for	ADP
ihlr-18810	709	46	the	the	DET
ihlr-18810	709	47	patient	patient	NOUN
ihlr-18810	709	48	regardless	regardless	ADV
ihlr-18810	709	49	of	of	ADP
ihlr-18810	709	50	cost	cost	NOUN
ihlr-18810	709	51	or	or	CCONJ
ihlr-18810	709	52	effect	effect	NOUN
ihlr-18810	709	53	on	on	ADP
ihlr-18810	709	54	others	other	NOUN
ihlr-18810	709	55	.	.	PUNCT
ihlr-18810	709	56	.	.	PUNCT
ihlr-18810	709	57	.	.	PUNCT
ihlr-18810	710	1	.	.	PUNCT
ihlr-18810	711	1	rapid	rapid	ADJ
ihlr-18810	711	2	reforms	reform	NOUN
ihlr-18810	711	3	of	of	ADP
ihlr-18810	711	4	medical	medical	ADJ
ihlr-18810	711	5	education	education	NOUN
ihlr-18810	711	6	and	and	CCONJ
ihlr-18810	711	7	training	training	NOUN
ihlr-18810	711	8	,	,	PUNCT
ihlr-18810	711	9	even	even	ADV
ihlr-18810	711	10	when	when	SCONJ
ihlr-18810	711	11	widely	widely	ADV
ihlr-18810	711	12	acknowledged	acknowledge	VERB
ihlr-18810	711	13	as	as	ADP
ihlr-18810	711	14	essential	essential	ADJ
ihlr-18810	711	15	,	,	PUNCT
ihlr-18810	711	16	are	be	AUX
ihlr-18810	711	17	uncommon	uncommon	ADJ
ihlr-18810	711	18	.	.	PUNCT
ihlr-18810	711	19	.	.	PUNCT
ihlr-18810	711	20	.	.	PUNCT
ihlr-18810	711	21	.	.	PUNCT
ihlr-18810	712	1	realistically	realistically	ADV
ihlr-18810	712	2	,	,	PUNCT
ihlr-18810	712	3	the	the	DET
ihlr-18810	712	4	most	most	ADV
ihlr-18810	712	5	effective	effective	ADJ
ihlr-18810	712	6	policy	policy	NOUN
ihlr-18810	712	7	change	change	NOUN
ihlr-18810	712	8	would	would	AUX
ihlr-18810	712	9	be	be	AUX
ihlr-18810	712	10	to	to	PART
ihlr-18810	712	11	alter	alter	VERB
ihlr-18810	712	12	how	how	SCONJ
ihlr-18810	712	13	insurance	insurance	NOUN
ihlr-18810	712	14	pays	pay	VERB
ihlr-18810	712	15	for	for	ADP
ihlr-18810	712	16	medical	medical	ADJ
ihlr-18810	712	17	services	service	NOUN
ihlr-18810	712	18	.	.	PUNCT
ihlr-18810	712	19	"	"	PUNCT
ihlr-18810	712	20	)	)	PUNCT
ihlr-18810	712	21	.	.	PUNCT
ihlr-18810	713	1	2013	2013	NUM
ihlr-18810	713	2	165	165	NUM
ihlr-18810	713	3	indiana	indiana	PROPN
ihlr-18810	713	4	health	health	PROPN
ihlr-18810	713	5	law	law	PROPN
ihlr-18810	713	6	review	review	NOUN
ihlr-18810	713	7	healthcare	healthcare	NOUN
ihlr-18810	713	8	based	base	VERB
ihlr-18810	713	9	on	on	ADP
ihlr-18810	713	10	their	their	PRON
ihlr-18810	713	11	age	age	NOUN
ihlr-18810	713	12	or	or	CCONJ
ihlr-18810	713	13	health	health	NOUN
ihlr-18810	713	14	status.276	status.276	PROPN
ihlr-18810	713	15	this	this	PRON
ihlr-18810	713	16	is	be	AUX
ihlr-18810	713	17	not	not	PART
ihlr-18810	713	18	at	at	ADV
ihlr-18810	713	19	all	all	DET
ihlr-18810	713	20	the	the	DET
ihlr-18810	713	21	use	use	NOUN
ihlr-18810	713	22	of	of	ADP
ihlr-18810	713	23	cer	cer	PROPN
ihlr-18810	713	24	presented	present	VERB
ihlr-18810	713	25	in	in	ADP
ihlr-18810	713	26	this	this	DET
ihlr-18810	713	27	article	article	NOUN
ihlr-18810	713	28	,	,	PUNCT
ihlr-18810	713	29	however	however	ADV
ihlr-18810	713	30	.	.	PUNCT
ihlr-18810	714	1	cer	cer	PROPN
ihlr-18810	714	2	would	would	AUX
ihlr-18810	714	3	be	be	AUX
ihlr-18810	714	4	used	use	VERB
ihlr-18810	714	5	not	not	PART
ihlr-18810	714	6	to	to	PART
ihlr-18810	714	7	deny	deny	VERB
ihlr-18810	714	8	all	all	DET
ihlr-18810	714	9	medical	medical	ADJ
ihlr-18810	714	10	treatment	treatment	NOUN
ihlr-18810	714	11	for	for	ADP
ihlr-18810	714	12	a	a	DET
ihlr-18810	714	13	patient	patient	NOUN
ihlr-18810	714	14	,	,	PUNCT
ihlr-18810	714	15	but	but	CCONJ
ihlr-18810	714	16	rather	rather	ADV
ihlr-18810	714	17	to	to	PART
ihlr-18810	714	18	provide	provide	VERB
ihlr-18810	714	19	an	an	DET
ihlr-18810	714	20	incentive	incentive	NOUN
ihlr-18810	714	21	for	for	SCONJ
ihlr-18810	714	22	healthcare	healthcare	NOUN
ihlr-18810	714	23	providers	provider	NOUN
ihlr-18810	714	24	to	to	PART
ihlr-18810	714	25	pursue	pursue	VERB
ihlr-18810	714	26	the	the	DET
ihlr-18810	714	27	treatment	treatment	NOUN
ihlr-18810	714	28	options	option	NOUN
ihlr-18810	714	29	that	that	PRON
ihlr-18810	714	30	will	will	AUX
ihlr-18810	714	31	present	present	VERB
ihlr-18810	714	32	the	the	DET
ihlr-18810	714	33	best	good	ADJ
ihlr-18810	714	34	possible	possible	ADJ
ihlr-18810	714	35	clinical	clinical	ADJ
ihlr-18810	714	36	outcome	outcome	NOUN
ihlr-18810	714	37	for	for	ADP
ihlr-18810	714	38	the	the	DET
ihlr-18810	714	39	patient	patient	NOUN
ihlr-18810	714	40	.	.	PUNCT
ihlr-18810	715	1	cer	cer	PROPN
ihlr-18810	715	2	by	by	ADP
ihlr-18810	715	3	definition	definition	NOUN
ihlr-18810	715	4	involves	involve	VERB
ihlr-18810	715	5	the	the	DET
ihlr-18810	715	6	comparison	comparison	NOUN
ihlr-18810	715	7	of	of	ADP
ihlr-18810	715	8	one	one	NUM
ihlr-18810	715	9	treatment	treatment	NOUN
ihlr-18810	715	10	option	option	NOUN
ihlr-18810	715	11	to	to	ADP
ihlr-18810	715	12	another	another	PRON
ihlr-18810	715	13	in	in	ADP
ihlr-18810	715	14	an	an	DET
ihlr-18810	715	15	effort	effort	NOUN
ihlr-18810	715	16	to	to	PART
ihlr-18810	715	17	determine	determine	VERB
ihlr-18810	715	18	which	which	PRON
ihlr-18810	715	19	of	of	ADP
ihlr-18810	715	20	the	the	DET
ihlr-18810	715	21	two	two	NUM
ihlr-18810	715	22	will	will	AUX
ihlr-18810	715	23	achieve	achieve	VERB
ihlr-18810	715	24	the	the	DET
ihlr-18810	715	25	best	good	ADJ
ihlr-18810	715	26	outcomes	outcome	NOUN
ihlr-18810	715	27	for	for	ADP
ihlr-18810	715	28	patients	patient	NOUN
ihlr-18810	715	29	with	with	ADP
ihlr-18810	715	30	the	the	DET
ihlr-18810	715	31	studied	study	VERB
ihlr-18810	715	32	illnesses	illness	NOUN
ihlr-18810	715	33	or	or	CCONJ
ihlr-18810	715	34	conditions	condition	NOUN
ihlr-18810	715	35	.	.	PUNCT
ihlr-18810	716	1	decisions	decision	NOUN
ihlr-18810	716	2	to	to	PART
ihlr-18810	716	3	pursue	pursue	VERB
ihlr-18810	716	4	a	a	DET
ihlr-18810	716	5	treatment	treatment	NOUN
ihlr-18810	716	6	option	option	NOUN
ihlr-18810	716	7	will	will	AUX
ihlr-18810	716	8	be	be	AUX
ihlr-18810	716	9	based	base	VERB
ihlr-18810	716	10	not	not	PART
ihlr-18810	716	11	on	on	ADP
ihlr-18810	716	12	the	the	DET
ihlr-18810	716	13	doctor	doctor	NOUN
ihlr-18810	716	14	's	's	PART
ihlr-18810	716	15	perception	perception	NOUN
ihlr-18810	716	16	of	of	ADP
ihlr-18810	716	17	the	the	DET
ihlr-18810	716	18	value	value	NOUN
ihlr-18810	716	19	to	to	ADP
ihlr-18810	716	20	society	society	NOUN
ihlr-18810	716	21	that	that	SCONJ
ihlr-18810	716	22	his	his	PRON
ihlr-18810	716	23	particular	particular	ADJ
ihlr-18810	716	24	patient	patient	NOUN
ihlr-18810	716	25	presents	present	NOUN
ihlr-18810	716	26	,	,	PUNCT
ihlr-18810	716	27	but	but	CCONJ
ihlr-18810	716	28	instead	instead	ADV
ihlr-18810	716	29	on	on	ADP
ihlr-18810	716	30	the	the	DET
ihlr-18810	716	31	potential	potential	NOUN
ihlr-18810	716	32	that	that	SCONJ
ihlr-18810	716	33	available	available	ADJ
ihlr-18810	716	34	options	option	NOUN
ihlr-18810	716	35	have	have	VERB
ihlr-18810	716	36	to	to	PART
ihlr-18810	716	37	successfully	successfully	ADV
ihlr-18810	716	38	treat	treat	VERB
ihlr-18810	716	39	the	the	DET
ihlr-18810	716	40	patient	patient	NOUN
ihlr-18810	716	41	,	,	PUNCT
ihlr-18810	716	42	based	base	VERB
ihlr-18810	716	43	on	on	ADP
ihlr-18810	716	44	sound	sound	ADJ
ihlr-18810	716	45	clinical	clinical	ADJ
ihlr-18810	716	46	evidence	evidence	NOUN
ihlr-18810	716	47	.	.	PUNCT
ihlr-18810	717	1	if	if	SCONJ
ihlr-18810	717	2	a	a	DET
ihlr-18810	717	3	particular	particular	ADJ
ihlr-18810	717	4	medical	medical	ADJ
ihlr-18810	717	5	device	device	NOUN
ihlr-18810	717	6	is	be	AUX
ihlr-18810	717	7	found	find	VERB
ihlr-18810	717	8	through	through	ADP
ihlr-18810	717	9	cer	cer	PROPN
ihlr-18810	717	10	to	to	PART
ihlr-18810	717	11	be	be	AUX
ihlr-18810	717	12	unable	unable	ADJ
ihlr-18810	717	13	to	to	PART
ihlr-18810	717	14	give	give	VERB
ihlr-18810	717	15	the	the	DET
ihlr-18810	717	16	patient	patient	NOUN
ihlr-18810	717	17	a	a	DET
ihlr-18810	717	18	chance	chance	NOUN
ihlr-18810	717	19	to	to	PART
ihlr-18810	717	20	achieve	achieve	VERB
ihlr-18810	717	21	a	a	DET
ihlr-18810	717	22	better	well	ADJ
ihlr-18810	717	23	health	health	NOUN
ihlr-18810	717	24	outcome	outcome	NOUN
ihlr-18810	717	25	than	than	ADP
ihlr-18810	717	26	another	another	DET
ihlr-18810	717	27	device	device	NOUN
ihlr-18810	717	28	,	,	PUNCT
ihlr-18810	717	29	drug	drug	NOUN
ihlr-18810	717	30	,	,	PUNCT
ihlr-18810	717	31	or	or	CCONJ
ihlr-18810	717	32	surgery	surgery	NOUN
ihlr-18810	717	33	may	may	AUX
ihlr-18810	717	34	,	,	PUNCT
ihlr-18810	717	35	then	then	ADV
ihlr-18810	717	36	coverage	coverage	NOUN
ihlr-18810	717	37	of	of	ADP
ihlr-18810	717	38	that	that	DET
ihlr-18810	717	39	treatment	treatment	NOUN
ihlr-18810	717	40	option	option	NOUN
ihlr-18810	717	41	would	would	AUX
ihlr-18810	717	42	be	be	AUX
ihlr-18810	717	43	denied	deny	VERB
ihlr-18810	717	44	under	under	ADP
ihlr-18810	717	45	this	this	DET
ihlr-18810	717	46	article	article	NOUN
ihlr-18810	717	47	's	's	PART
ihlr-18810	717	48	proposal	proposal	NOUN
ihlr-18810	717	49	.	.	PUNCT
ihlr-18810	718	1	the	the	DET
ihlr-18810	718	2	patient	patient	NOUN
ihlr-18810	718	3	would	would	AUX
ihlr-18810	718	4	still	still	ADV
ihlr-18810	718	5	have	have	VERB
ihlr-18810	718	6	the	the	DET
ihlr-18810	718	7	choice	choice	NOUN
ihlr-18810	718	8	to	to	PART
ihlr-18810	718	9	pursue	pursue	VERB
ihlr-18810	718	10	that	that	DET
ihlr-18810	718	11	treatment	treatment	NOUN
ihlr-18810	718	12	option	option	NOUN
ihlr-18810	718	13	if	if	SCONJ
ihlr-18810	718	14	he	he	PRON
ihlr-18810	718	15	wants	want	VERB
ihlr-18810	718	16	to	to	PART
ihlr-18810	718	17	pay	pay	VERB
ihlr-18810	718	18	out	out	ADP
ihlr-18810	718	19	of	of	ADP
ihlr-18810	718	20	pocket	pocket	NOUN
ihlr-18810	718	21	for	for	ADP
ihlr-18810	718	22	the	the	DET
ihlr-18810	718	23	costs	cost	NOUN
ihlr-18810	718	24	(	(	PUNCT
ihlr-18810	718	25	just	just	ADV
ihlr-18810	718	26	as	as	SCONJ
ihlr-18810	718	27	medical	medical	ADJ
ihlr-18810	718	28	tourism	tourism	NOUN
ihlr-18810	718	29	presents	present	VERB
ihlr-18810	718	30	this	this	DET
ihlr-18810	718	31	option	option	NOUN
ihlr-18810	718	32	to	to	ADP
ihlr-18810	718	33	patients	patient	NOUN
ihlr-18810	718	34	now),277	now),277	PROPN
ihlr-18810	718	35	but	but	CCONJ
ihlr-18810	718	36	the	the	DET
ihlr-18810	718	37	use	use	NOUN
ihlr-18810	718	38	of	of	ADP
ihlr-18810	718	39	treatment	treatment	NOUN
ihlr-18810	718	40	options	option	NOUN
ihlr-18810	718	41	found	find	VERB
ihlr-18810	718	42	through	through	ADP
ihlr-18810	718	43	clinical	clinical	ADJ
ihlr-18810	718	44	evidence	evidence	NOUN
ihlr-18810	718	45	to	to	PART
ihlr-18810	718	46	be	be	AUX
ihlr-18810	718	47	safer	safe	ADJ
ihlr-18810	718	48	and	and	CCONJ
ihlr-18810	718	49	to	to	PART
ihlr-18810	718	50	lead	lead	VERB
ihlr-18810	718	51	to	to	ADP
ihlr-18810	718	52	better	well	ADJ
ihlr-18810	718	53	healthcare	healthcare	NOUN
ihlr-18810	718	54	outcomes	outcome	NOUN
ihlr-18810	718	55	would	would	AUX
ihlr-18810	718	56	be	be	AUX
ihlr-18810	718	57	incentivized	incentivize	VERB
ihlr-18810	718	58	.	.	PUNCT
ihlr-18810	719	1	in	in	ADP
ihlr-18810	719	2	this	this	DET
ihlr-18810	719	3	way	way	NOUN
ihlr-18810	719	4	,	,	PUNCT
ihlr-18810	719	5	the	the	DET
ihlr-18810	719	6	necessary	necessary	ADJ
ihlr-18810	719	7	post	post	ADJ
ihlr-18810	719	8	-	-	ADJ
ihlr-18810	719	9	market	market	ADJ
ihlr-18810	719	10	surveillance	surveillance	NOUN
ihlr-18810	719	11	the	the	DET
ihlr-18810	719	12	fda	fda	PROPN
ihlr-18810	719	13	does	do	AUX
ihlr-18810	719	14	not	not	PART
ihlr-18810	719	15	have	have	VERB
ihlr-18810	719	16	the	the	DET
ihlr-18810	719	17	resources	resource	NOUN
ihlr-18810	719	18	to	to	PART
ihlr-18810	719	19	conduct	conduct	VERB
ihlr-18810	719	20	will	will	AUX
ihlr-18810	719	21	be	be	AUX
ihlr-18810	719	22	undertaken	undertake	VERB
ihlr-18810	719	23	by	by	ADP
ihlr-18810	719	24	an	an	DET
ihlr-18810	719	25	agency	agency	NOUN
ihlr-18810	719	26	of	of	ADP
ihlr-18810	719	27	the	the	DET
ihlr-18810	719	28	government	government	NOUN
ihlr-18810	719	29	with	with	ADP
ihlr-18810	719	30	the	the	DET
ihlr-18810	719	31	resources	resource	NOUN
ihlr-18810	719	32	and	and	CCONJ
ihlr-18810	719	33	manpower	manpower	NOUN
ihlr-18810	719	34	to	to	PART
ihlr-18810	719	35	effectively	effectively	ADV
ihlr-18810	719	36	monitor	monitor	VERB
ihlr-18810	719	37	the	the	DET
ihlr-18810	719	38	devices	device	NOUN
ihlr-18810	719	39	.	.	PUNCT
ihlr-18810	720	1	additionally	additionally	ADV
ihlr-18810	720	2	,	,	PUNCT
ihlr-18810	720	3	concerns	concern	NOUN
ihlr-18810	720	4	raised	raise	VERB
ihlr-18810	720	5	by	by	ADP
ihlr-18810	720	6	the	the	DET
ihlr-18810	720	7	industry	industry	NOUN
ihlr-18810	720	8	and	and	CCONJ
ihlr-18810	720	9	patients	patient	NOUN
ihlr-18810	720	10	that	that	PRON
ihlr-18810	720	11	further	further	ADJ
ihlr-18810	720	12	regulation	regulation	NOUN
ihlr-18810	720	13	will	will	AUX
ihlr-18810	720	14	dampen	dampen	VERB
ihlr-18810	720	15	innovation	innovation	NOUN
ihlr-18810	720	16	and	and	CCONJ
ihlr-18810	720	17	further	far	ADV
ihlr-18810	720	18	delay	delay	VERB
ihlr-18810	720	19	the	the	DET
ihlr-18810	720	20	availability	availability	NOUN
ihlr-18810	720	21	of	of	ADP
ihlr-18810	720	22	devices	device	NOUN
ihlr-18810	720	23	in	in	ADP
ihlr-18810	720	24	the	the	DET
ihlr-18810	720	25	u.s	u.s	PROPN
ihlr-18810	720	26	.	.	PROPN
ihlr-18810	720	27	market	market	NOUN
ihlr-18810	720	28	will	will	AUX
ihlr-18810	720	29	276	276	NUM
ihlr-18810	720	30	see	see	VERB
ihlr-18810	720	31	,	,	PUNCT
ihlr-18810	720	32	e.g.	e.g.	ADV
ihlr-18810	720	33	,	,	PUNCT
ihlr-18810	720	34	michele	michele	PROPN
ihlr-18810	720	35	bachmann	bachmann	PROPN
ihlr-18810	720	36	,	,	PUNCT
ihlr-18810	720	37	the	the	DET
ihlr-18810	720	38	president	president	NOUN
ihlr-18810	720	39	's	's	PART
ihlr-18810	720	40	health	health	NOUN
ihlr-18810	720	41	care	care	NOUN
ihlr-18810	720	42	advisers	adviser	NOUN
ihlr-18810	720	43	,	,	PUNCT
ihlr-18810	720	44	youtube	youtube	NOUN
ihlr-18810	720	45	(	(	PUNCT
ihlr-18810	720	46	july	july	PROPN
ihlr-18810	720	47	31	31	NUM
ihlr-18810	720	48	,	,	PUNCT
ihlr-18810	720	49	2009	2009	NUM
ihlr-18810	720	50	)	)	PUNCT
ihlr-18810	720	51	,	,	PUNCT
ihlr-18810	720	52	http://www.youtube.com/	http://www.youtube.com/	NOUN
ihlr-18810	720	53	watch?v=5chbvkgmevi	watch?v=5chbvkgmevi	NOUN
ihlr-18810	720	54	(	(	PUNCT
ihlr-18810	720	55	arguing	argue	VERB
ihlr-18810	720	56	that	that	SCONJ
ihlr-18810	720	57	the	the	DET
ihlr-18810	720	58	health	health	NOUN
ihlr-18810	720	59	reform	reform	NOUN
ihlr-18810	720	60	bill	bill	NOUN
ihlr-18810	720	61	would	would	AUX
ihlr-18810	720	62	result	result	VERB
ihlr-18810	720	63	in	in	ADP
ihlr-18810	720	64	the	the	DET
ihlr-18810	720	65	inclusion	inclusion	NOUN
ihlr-18810	720	66	into	into	ADP
ihlr-18810	720	67	a	a	DET
ihlr-18810	720	68	doctor	doctor	NOUN
ihlr-18810	720	69	's	's	PART
ihlr-18810	720	70	healthcare	healthcare	NOUN
ihlr-18810	720	71	decision	decision	NOUN
ihlr-18810	720	72	-	-	PUNCT
ihlr-18810	720	73	making	make	VERB
ihlr-18810	720	74	process	process	NOUN
ihlr-18810	720	75	considerations	consideration	NOUN
ihlr-18810	720	76	of	of	ADP
ihlr-18810	720	77	whether	whether	SCONJ
ihlr-18810	720	78	the	the	DET
ihlr-18810	720	79	healthcare	healthcare	NOUN
ihlr-18810	720	80	dollars	dollar	NOUN
ihlr-18810	720	81	"	"	PUNCT
ihlr-18810	720	82	would	would	AUX
ihlr-18810	720	83	be	be	AUX
ihlr-18810	720	84	better	well	ADV
ihlr-18810	720	85	spent	spend	VERB
ihlr-18810	720	86	on	on	ADP
ihlr-18810	720	87	someone	someone	PRON
ihlr-18810	720	88	else	else	ADV
ihlr-18810	720	89	,	,	PUNCT
ihlr-18810	720	90	"	"	PUNCT
ihlr-18810	720	91	reserving	reserve	VERB
ihlr-18810	720	92	medical	medical	ADJ
ihlr-18810	720	93	care	care	NOUN
ihlr-18810	720	94	for	for	ADP
ihlr-18810	720	95	only	only	ADV
ihlr-18810	720	96	those	those	DET
ihlr-18810	720	97	patients	patient	NOUN
ihlr-18810	720	98	who	who	PRON
ihlr-18810	720	99	are	be	AUX
ihlr-18810	720	100	non	non	ADJ
ihlr-18810	720	101	-	-	ADJ
ihlr-18810	720	102	disabled	disabled	ADJ
ihlr-18810	720	103	;	;	PUNCT
ihlr-18810	720	104	who	who	PRON
ihlr-18810	720	105	have	have	AUX
ihlr-18810	720	106	not	not	PART
ihlr-18810	720	107	yet	yet	ADV
ihlr-18810	720	108	been	be	AUX
ihlr-18810	720	109	irreversibly	irreversibly	ADV
ihlr-18810	720	110	prevented	prevent	VERB
ihlr-18810	720	111	from	from	ADP
ihlr-18810	720	112	participating	participate	VERB
ihlr-18810	720	113	in	in	ADP
ihlr-18810	720	114	society	society	NOUN
ihlr-18810	720	115	)	)	PUNCT
ihlr-18810	720	116	.	.	PUNCT
ihlr-18810	721	1	277	277	NUM
ihlr-18810	721	2	see	see	VERB
ihlr-18810	721	3	cohen	cohen	PROPN
ihlr-18810	721	4	,	,	PUNCT
ihlr-18810	721	5	supra	supra	PROPN
ihlr-18810	721	6	note	note	PROPN
ihlr-18810	721	7	219	219	NUM
ihlr-18810	721	8	,	,	PUNCT
ihlr-18810	721	9	at	at	ADP
ihlr-18810	721	10	1489	1489	NUM
ihlr-18810	721	11	.	.	PUNCT
ihlr-18810	722	1	166	166	NUM
ihlr-18810	722	2	vol	vol	NOUN
ihlr-18810	722	3	.	.	PUNCT
ihlr-18810	723	1	10:1	10:1	NUM
ihlr-18810	723	2	510(k	510(k	NUM
ihlr-18810	723	3	)	)	PUNCT
ihlr-18810	723	4	clearance	clearance	NOUN
ihlr-18810	723	5	never	never	ADV
ihlr-18810	723	6	be	be	AUX
ihlr-18810	723	7	realized	realize	VERB
ihlr-18810	723	8	,	,	PUNCT
ihlr-18810	723	9	because	because	SCONJ
ihlr-18810	723	10	devices	device	NOUN
ihlr-18810	723	11	will	will	AUX
ihlr-18810	723	12	still	still	ADV
ihlr-18810	723	13	be	be	AUX
ihlr-18810	723	14	cleared	clear	VERB
ihlr-18810	723	15	for	for	ADP
ihlr-18810	723	16	marketing	marketing	NOUN
ihlr-18810	723	17	through	through	ADP
ihlr-18810	723	18	the	the	DET
ihlr-18810	723	19	quicker	quick	ADJ
ihlr-18810	723	20	process	process	NOUN
ihlr-18810	723	21	and	and	CCONJ
ihlr-18810	723	22	remain	remain	VERB
ihlr-18810	723	23	available	available	ADJ
ihlr-18810	723	24	to	to	ADP
ihlr-18810	723	25	patients278	patients278	PROPN
ihlr-18810	723	26	even	even	ADV
ihlr-18810	723	27	if	if	SCONJ
ihlr-18810	723	28	government	government	NOUN
ihlr-18810	723	29	payers	payer	NOUN
ihlr-18810	723	30	later	later	ADV
ihlr-18810	723	31	determine	determine	VERB
ihlr-18810	723	32	,	,	PUNCT
ihlr-18810	723	33	based	base	VERB
ihlr-18810	723	34	on	on	ADP
ihlr-18810	723	35	subsequently	subsequently	ADV
ihlr-18810	723	36	conducted	conduct	VERB
ihlr-18810	723	37	cer	cer	PROPN
ihlr-18810	723	38	,	,	PUNCT
ihlr-18810	723	39	not	not	PART
ihlr-18810	723	40	to	to	PART
ihlr-18810	723	41	cover	cover	VERB
ihlr-18810	723	42	certain	certain	ADJ
ihlr-18810	723	43	devices	device	NOUN
ihlr-18810	723	44	in	in	ADP
ihlr-18810	723	45	certain	certain	ADJ
ihlr-18810	723	46	circumstances	circumstance	NOUN
ihlr-18810	723	47	.	.	PUNCT
ihlr-18810	724	1	furthermore	furthermore	ADV
ihlr-18810	724	2	,	,	PUNCT
ihlr-18810	724	3	the	the	DET
ihlr-18810	724	4	government	government	NOUN
ihlr-18810	724	5	will	will	AUX
ihlr-18810	724	6	have	have	VERB
ihlr-18810	724	7	enough	enough	ADJ
ihlr-18810	724	8	leverage	leverage	NOUN
ihlr-18810	724	9	to	to	PART
ihlr-18810	724	10	effectively	effectively	ADV
ihlr-18810	724	11	incentivize	incentivize	VERB
ihlr-18810	724	12	the	the	DET
ihlr-18810	724	13	medical	medical	ADJ
ihlr-18810	724	14	device	device	NOUN
ihlr-18810	724	15	industry	industry	NOUN
ihlr-18810	724	16	to	to	PART
ihlr-18810	724	17	improve	improve	VERB
ihlr-18810	724	18	the	the	DET
ihlr-18810	724	19	safety	safety	NOUN
ihlr-18810	724	20	and	and	CCONJ
ihlr-18810	724	21	efficacy	efficacy	NOUN
ihlr-18810	724	22	of	of	ADP
ihlr-18810	724	23	their	their	PRON
ihlr-18810	724	24	devices	device	NOUN
ihlr-18810	724	25	.	.	PUNCT
ihlr-18810	725	1	as	as	SCONJ
ihlr-18810	725	2	already	already	ADV
ihlr-18810	725	3	mentioned	mention	VERB
ihlr-18810	725	4	,	,	PUNCT
ihlr-18810	725	5	overall	overall	ADV
ihlr-18810	725	6	the	the	DET
ihlr-18810	725	7	u.s	u.s	PROPN
ihlr-18810	725	8	.	.	PROPN
ihlr-18810	725	9	spends	spend	VERB
ihlr-18810	725	10	over	over	ADP
ihlr-18810	725	11	$	$	SYM
ihlr-18810	725	12	2	2	NUM
ihlr-18810	725	13	trillion	trillion	NUM
ihlr-18810	725	14	on	on	ADP
ihlr-18810	725	15	health	health	NOUN
ihlr-18810	725	16	annually	annually	ADV
ihlr-18810	725	17	,	,	PUNCT
ihlr-18810	725	18	about	about	ADV
ihlr-18810	725	19	45	45	NUM
ihlr-18810	725	20	%	%	NOUN
ihlr-18810	725	21	of	of	ADP
ihlr-18810	725	22	these	these	DET
ihlr-18810	725	23	expenditures	expenditure	NOUN
ihlr-18810	725	24	made	make	VERB
ihlr-18810	725	25	by	by	ADP
ihlr-18810	725	26	the	the	DET
ihlr-18810	725	27	government	government	NOUN
ihlr-18810	725	28	.	.	PUNCT
ihlr-18810	726	1	279	279	NUM
ihlr-18810	726	2	this	this	DET
ihlr-18810	726	3	figure	figure	NOUN
ihlr-18810	726	4	includes	include	VERB
ihlr-18810	726	5	all	all	DET
ihlr-18810	726	6	expenditures	expenditure	NOUN
ihlr-18810	726	7	made	make	VERB
ihlr-18810	726	8	under	under	ADP
ihlr-18810	726	9	the	the	DET
ihlr-18810	726	10	medicaid	medicaid	PROPN
ihlr-18810	726	11	and	and	CCONJ
ihlr-18810	726	12	medicare	medicare	PROPN
ihlr-18810	726	13	programs	program	NOUN
ihlr-18810	726	14	,	,	PUNCT
ihlr-18810	726	15	as	as	ADV
ihlr-18810	726	16	well	well	ADV
ihlr-18810	726	17	as	as	ADP
ihlr-18810	726	18	expenditures	expenditure	NOUN
ihlr-18810	726	19	made	make	VERB
ihlr-18810	726	20	for	for	ADP
ihlr-18810	726	21	the	the	DET
ihlr-18810	726	22	veterans	veterans	PROPN
ihlr-18810	726	23	health	health	PROPN
ihlr-18810	726	24	administration	administration	PROPN
ihlr-18810	726	25	,	,	PUNCT
ihlr-18810	726	26	indian	indian	PROPN
ihlr-18810	726	27	health	health	NOUN
ihlr-18810	726	28	service	service	NOUN
ihlr-18810	726	29	,	,	PUNCT
ihlr-18810	726	30	and	and	CCONJ
ihlr-18810	726	31	federal	federal	ADJ
ihlr-18810	726	32	employees	employee	NOUN
ihlr-18810	726	33	health	health	NOUN
ihlr-18810	726	34	benefit	benefit	NOUN
ihlr-18810	726	35	plan.28	plan.28	NOUN
ihlr-18810	726	36	0	0	NUM
ihlr-18810	727	1	the	the	DET
ihlr-18810	727	2	government	government	NOUN
ihlr-18810	727	3	constitutes	constitute	VERB
ihlr-18810	727	4	a	a	DET
ihlr-18810	727	5	large	large	ADJ
ihlr-18810	727	6	share	share	NOUN
ihlr-18810	727	7	of	of	ADP
ihlr-18810	727	8	the	the	DET
ihlr-18810	727	9	payer	payer	NOUN
ihlr-18810	727	10	market	market	NOUN
ihlr-18810	727	11	.	.	PUNCT
ihlr-18810	728	1	medical	medical	ADJ
ihlr-18810	728	2	device	device	NOUN
ihlr-18810	728	3	companies	company	NOUN
ihlr-18810	728	4	,	,	PUNCT
ihlr-18810	728	5	understandably	understandably	ADV
ihlr-18810	728	6	profit	profit	NOUN
ihlr-18810	728	7	driven	drive	VERB
ihlr-18810	728	8	,	,	PUNCT
ihlr-18810	728	9	will	will	AUX
ihlr-18810	728	10	be	be	AUX
ihlr-18810	728	11	much	much	ADV
ihlr-18810	728	12	more	more	ADV
ihlr-18810	728	13	inclined	inclined	ADJ
ihlr-18810	728	14	to	to	PART
ihlr-18810	728	15	put	put	VERB
ihlr-18810	728	16	forth	forth	ADP
ihlr-18810	728	17	the	the	DET
ihlr-18810	728	18	effort	effort	NOUN
ihlr-18810	728	19	to	to	PART
ihlr-18810	728	20	ensure	ensure	VERB
ihlr-18810	728	21	their	their	PRON
ihlr-18810	728	22	devices	device	NOUN
ihlr-18810	728	23	are	be	AUX
ihlr-18810	728	24	safe	safe	ADJ
ihlr-18810	728	25	and	and	CCONJ
ihlr-18810	728	26	effective	effective	ADJ
ihlr-18810	728	27	enough	enough	ADV
ihlr-18810	728	28	to	to	PART
ihlr-18810	728	29	qualify	qualify	VERB
ihlr-18810	728	30	for	for	ADP
ihlr-18810	728	31	coverage	coverage	NOUN
ihlr-18810	728	32	under	under	ADP
ihlr-18810	728	33	government	government	NOUN
ihlr-18810	728	34	health	health	NOUN
ihlr-18810	728	35	programs	program	NOUN
ihlr-18810	728	36	than	than	SCONJ
ihlr-18810	728	37	they	they	PRON
ihlr-18810	728	38	would	would	AUX
ihlr-18810	728	39	by	by	ADP
ihlr-18810	728	40	coverage	coverage	NOUN
ihlr-18810	728	41	determinations	determination	NOUN
ihlr-18810	728	42	of	of	ADP
ihlr-18810	728	43	individual	individual	ADJ
ihlr-18810	728	44	private	private	ADJ
ihlr-18810	728	45	insurers	insurer	NOUN
ihlr-18810	728	46	,	,	PUNCT
ihlr-18810	728	47	which	which	PRON
ihlr-18810	728	48	each	each	PRON
ihlr-18810	728	49	cover	cover	VERB
ihlr-18810	728	50	a	a	DET
ihlr-18810	728	51	much	much	ADV
ihlr-18810	728	52	smaller	small	ADJ
ihlr-18810	728	53	share	share	NOUN
ihlr-18810	728	54	of	of	ADP
ihlr-18810	728	55	the	the	DET
ihlr-18810	728	56	patient	patient	ADJ
ihlr-18810	728	57	market	market	NOUN
ihlr-18810	728	58	.	.	PUNCT
ihlr-18810	729	1	limiting	limit	VERB
ihlr-18810	729	2	the	the	DET
ihlr-18810	729	3	devices	device	NOUN
ihlr-18810	729	4	covered	cover	VERB
ihlr-18810	729	5	under	under	ADP
ihlr-18810	729	6	the	the	DET
ihlr-18810	729	7	government	government	NOUN
ihlr-18810	729	8	programs	program	NOUN
ihlr-18810	729	9	is	be	AUX
ihlr-18810	729	10	not	not	PART
ihlr-18810	729	11	likely	likely	ADJ
ihlr-18810	729	12	to	to	PART
ihlr-18810	729	13	result	result	VERB
ihlr-18810	729	14	in	in	ADP
ihlr-18810	729	15	harm	harm	NOUN
ihlr-18810	729	16	to	to	PART
ihlr-18810	729	17	patient	patient	VERB
ihlr-18810	729	18	outcomes	outcome	NOUN
ihlr-18810	729	19	either	either	ADV
ihlr-18810	729	20	.	.	PUNCT
ihlr-18810	730	1	the	the	DET
ihlr-18810	730	2	u.s	u.s	PROPN
ihlr-18810	730	3	.	.	PROPN
ihlr-18810	730	4	spends	spend	VERB
ihlr-18810	730	5	more	more	ADJ
ihlr-18810	730	6	on	on	ADP
ihlr-18810	730	7	healthcare	healthcare	NOUN
ihlr-18810	730	8	than	than	ADP
ihlr-18810	730	9	any	any	DET
ihlr-18810	730	10	other	other	ADJ
ihlr-18810	730	11	country	country	NOUN
ihlr-18810	730	12	,	,	PUNCT
ihlr-18810	730	13	with	with	ADP
ihlr-18810	730	14	per	per	ADP
ihlr-18810	730	15	capita	capita	NOUN
ihlr-18810	730	16	expenditures	expenditure	NOUN
ihlr-18810	730	17	double	double	VERB
ihlr-18810	730	18	that	that	PRON
ihlr-18810	730	19	of	of	ADP
ihlr-18810	730	20	european	european	ADJ
ihlr-18810	730	21	countries	country	NOUN
ihlr-18810	730	22	and	and	CCONJ
ihlr-18810	730	23	at	at	ADV
ihlr-18810	730	24	least	least	ADV
ihlr-18810	730	25	20	20	NUM
ihlr-18810	730	26	%	%	NOUN
ihlr-18810	730	27	higher	high	ADJ
ihlr-18810	730	28	than	than	ADP
ihlr-18810	730	29	every	every	DET
ihlr-18810	730	30	other	other	ADJ
ihlr-18810	730	31	country	country	NOUN
ihlr-18810	730	32	.	.	PUNCT
ihlr-18810	731	1	281	281	NUM
ihlr-18810	731	2	even	even	ADV
ihlr-18810	731	3	with	with	ADP
ihlr-18810	731	4	all	all	PRON
ihlr-18810	731	5	of	of	ADP
ihlr-18810	731	6	this	this	DET
ihlr-18810	731	7	spending	spending	NOUN
ihlr-18810	731	8	on	on	ADP
ihlr-18810	731	9	healthcare	healthcare	PROPN
ihlr-18810	731	10	,	,	PUNCT
ihlr-18810	731	11	the	the	DET
ihlr-18810	731	12	u.s	u.s	PROPN
ihlr-18810	731	13	.	.	PROPN
ihlr-18810	731	14	ranks	rank	NOUN
ihlr-18810	731	15	are	be	AUX
ihlr-18810	731	16	well	well	ADV
ihlr-18810	731	17	below	below	ADP
ihlr-18810	731	18	other	other	ADJ
ihlr-18810	731	19	countries	country	NOUN
ihlr-18810	731	20	in	in	ADP
ihlr-18810	731	21	terms	term	NOUN
ihlr-18810	731	22	of	of	ADP
ihlr-18810	731	23	health	health	NOUN
ihlr-18810	731	24	outcomes	outcome	NOUN
ihlr-18810	731	25	.	.	PUNCT
ihlr-18810	732	1	the	the	DET
ihlr-18810	732	2	u.s	u.s	PROPN
ihlr-18810	732	3	.	.	PROPN
ihlr-18810	732	4	ranks	rank	VERB
ihlr-18810	732	5	twenty	twenty	NUM
ihlr-18810	732	6	-	-	PUNCT
ihlr-18810	732	7	eighth	eighth	ADJ
ihlr-18810	732	8	in	in	ADP
ihlr-18810	732	9	the	the	DET
ihlr-18810	732	10	world	world	NOUN
ihlr-18810	732	11	for	for	ADP
ihlr-18810	732	12	overall	overall	ADJ
ihlr-18810	732	13	life	life	NOUN
ihlr-18810	732	14	expectancy	expectancy	NOUN
ihlr-18810	732	15	at	at	ADP
ihlr-18810	732	16	birth.282	birth.282	PROPN
ihlr-18810	732	17	specifically	specifically	ADV
ihlr-18810	732	18	,	,	PUNCT
ihlr-18810	732	19	the	the	DET
ihlr-18810	732	20	average	average	ADJ
ihlr-18810	732	21	life	life	NOUN
ihlr-18810	732	22	expectancy	expectancy	NOUN
ihlr-18810	732	23	in	in	ADP
ihlr-18810	732	24	the	the	DET
ihlr-18810	732	25	u.s	u.s	PROPN
ihlr-18810	732	26	.	.	PROPN
ihlr-18810	732	27	at	at	ADP
ihlr-18810	732	28	birth	birth	NOUN
ihlr-18810	732	29	in	in	ADP
ihlr-18810	732	30	2009	2009	NUM
ihlr-18810	732	31	was	be	AUX
ihlr-18810	732	32	278	278	NUM
ihlr-18810	732	33	patients	patient	NOUN
ihlr-18810	732	34	will	will	AUX
ihlr-18810	732	35	still	still	ADV
ihlr-18810	732	36	have	have	VERB
ihlr-18810	732	37	the	the	DET
ihlr-18810	732	38	option	option	NOUN
ihlr-18810	732	39	to	to	PART
ihlr-18810	732	40	pay	pay	VERB
ihlr-18810	732	41	out	out	ADP
ihlr-18810	732	42	of	of	ADP
ihlr-18810	732	43	pocket	pocket	NOUN
ihlr-18810	732	44	for	for	ADP
ihlr-18810	732	45	any	any	DET
ihlr-18810	732	46	treatments	treatment	NOUN
ihlr-18810	732	47	not	not	PART
ihlr-18810	732	48	covered	cover	VERB
ihlr-18810	732	49	by	by	ADP
ihlr-18810	732	50	their	their	PRON
ihlr-18810	732	51	insurer	insurer	NOUN
ihlr-18810	732	52	.	.	PUNCT
ihlr-18810	733	1	279	279	NUM
ihlr-18810	733	2	iom	iom	PROPN
ihlr-18810	733	3	ce	ce	PROPN
ihlr-18810	733	4	,	,	PUNCT
ihlr-18810	733	5	supra	supra	PROPN
ihlr-18810	733	6	note	note	PROPN
ihlr-18810	733	7	244	244	NUM
ihlr-18810	733	8	,	,	PUNCT
ihlr-18810	733	9	at	at	ADP
ihlr-18810	733	10	6	6	NUM
ihlr-18810	733	11	.	.	NOUN
ihlr-18810	733	12	280	280	NUM
ihlr-18810	733	13	i	i	NOUN
ihlr-18810	733	14	d.	d.	NOUN
ihlr-18810	733	15	at	at	ADP
ihlr-18810	733	16	2	2	NUM
ihlr-18810	733	17	.	.	NUM
ihlr-18810	733	18	281	281	NUM
ihlr-18810	733	19	i	i	PRON
ihlr-18810	733	20	d.	d.	PROPN
ihlr-18810	733	21	at	at	ADP
ihlr-18810	733	22	3	3	NUM
ihlr-18810	733	23	.	.	NOUN
ihlr-18810	733	24	282	282	NUM
ihlr-18810	734	1	i	i	PRON
ihlr-18810	734	2	d.	d.	PROPN
ihlr-18810	734	3	at	at	ADP
ihlr-18810	734	4	1	1	NUM
ihlr-18810	734	5	.	.	PUNCT
ihlr-18810	734	6	2013	2013	NUM
ihlr-18810	734	7	187	187	NUM
ihlr-18810	734	8	indiana	indiana	PROPN
ihlr-18810	734	9	health	health	PROPN
ihlr-18810	734	10	law	law	PROPN
ihlr-18810	734	11	review	review	VERB
ihlr-18810	734	12	seventy	seventy	NUM
ihlr-18810	734	13	-	-	PUNCT
ihlr-18810	734	14	six	six	NUM
ihlr-18810	734	15	years	year	NOUN
ihlr-18810	734	16	for	for	ADP
ihlr-18810	734	17	men	man	NOUN
ihlr-18810	734	18	and	and	CCONJ
ihlr-18810	734	19	80.9	80.9	NUM
ihlr-18810	734	20	years	year	NOUN
ihlr-18810	734	21	for	for	ADP
ihlr-18810	734	22	women	woman	NOUN
ihlr-18810	734	23	.	.	PUNCT
ihlr-18810	735	1	283	283	NUM
ihlr-18810	735	2	by	by	ADP
ihlr-18810	735	3	comparison	comparison	NOUN
ihlr-18810	735	4	,	,	PUNCT
ihlr-18810	735	5	the	the	DET
ihlr-18810	735	6	life	life	NOUN
ihlr-18810	735	7	expectancies	expectancy	NOUN
ihlr-18810	735	8	in	in	ADP
ihlr-18810	735	9	the	the	DET
ihlr-18810	735	10	united	united	PROPN
ihlr-18810	735	11	kingdom	kingdom	PROPN
ihlr-18810	735	12	were	be	AUX
ihlr-18810	735	13	seventy	seventy	NUM
ihlr-18810	735	14	-	-	PUNCT
ihlr-18810	735	15	eight	eight	NUM
ihlr-18810	735	16	years	year	NOUN
ihlr-18810	735	17	and	and	CCONJ
ihlr-18810	735	18	82.2	82.2	NUM
ihlr-18810	735	19	years	year	NOUN
ihlr-18810	735	20	,	,	PUNCT
ihlr-18810	735	21	284	284	NUM
ihlr-18810	735	22	for	for	ADP
ihlr-18810	735	23	france	france	PROPN
ihlr-18810	735	24	77.8	77.8	NUM
ihlr-18810	735	25	and	and	CCONJ
ihlr-18810	735	26	84.8	84.8	NUM
ihlr-18810	735	27	years	year	NOUN
ihlr-18810	735	28	,	,	PUNCT
ihlr-18810	735	29	285	285	NUM
ihlr-18810	735	30	and	and	CCONJ
ihlr-18810	735	31	for	for	ADP
ihlr-18810	735	32	japan	japan	PROPN
ihlr-18810	735	33	(	(	PUNCT
ihlr-18810	735	34	with	with	ADP
ihlr-18810	735	35	the	the	DET
ihlr-18810	735	36	world	world	NOUN
ihlr-18810	735	37	's	's	PART
ihlr-18810	735	38	longest	long	ADJ
ihlr-18810	735	39	life	life	NOUN
ihlr-18810	735	40	expectancy286	expectancy286	PROPN
ihlr-18810	735	41	)	)	PUNCT
ihlr-18810	735	42	79.6	79.6	NUM
ihlr-18810	735	43	and	and	CCONJ
ihlr-18810	735	44	86.5	86.5	NUM
ihlr-18810	735	45	years	year	NOUN
ihlr-18810	735	46	,	,	PUNCT
ihlr-18810	735	47	287	287	NUM
ihlr-18810	735	48	respectively	respectively	ADV
ihlr-18810	735	49	.	.	PUNCT
ihlr-18810	736	1	variations	variation	NOUN
ihlr-18810	736	2	in	in	ADP
ihlr-18810	736	3	healthcare	healthcare	PROPN
ihlr-18810	736	4	service	service	NOUN
ihlr-18810	736	5	utilization	utilization	NOUN
ihlr-18810	736	6	are	be	AUX
ihlr-18810	736	7	prevalent	prevalent	ADJ
ihlr-18810	736	8	within	within	ADP
ihlr-18810	736	9	the	the	DET
ihlr-18810	736	10	u.s	u.s	PROPN
ihlr-18810	736	11	.	.	PROPN
ihlr-18810	736	12	as	as	ADV
ihlr-18810	736	13	well	well	ADV
ihlr-18810	736	14	.	.	PUNCT
ihlr-18810	737	1	it	it	PRON
ihlr-18810	737	2	has	have	AUX
ihlr-18810	737	3	been	be	AUX
ihlr-18810	737	4	found	find	VERB
ihlr-18810	737	5	that	that	SCONJ
ihlr-18810	737	6	intensity	intensity	NOUN
ihlr-18810	737	7	of	of	ADP
ihlr-18810	737	8	services	service	NOUN
ihlr-18810	737	9	for	for	ADP
ihlr-18810	737	10	similar	similar	ADJ
ihlr-18810	737	11	conditions	condition	NOUN
ihlr-18810	737	12	can	can	AUX
ihlr-18810	737	13	vary	vary	VERB
ihlr-18810	737	14	by	by	ADP
ihlr-18810	737	15	as	as	ADV
ihlr-18810	737	16	much	much	ADJ
ihlr-18810	737	17	as	as	ADP
ihlr-18810	737	18	a	a	DET
ihlr-18810	737	19	factor	factor	NOUN
ihlr-18810	737	20	of	of	ADP
ihlr-18810	737	21	twenty	twenty	NUM
ihlr-18810	737	22	,	,	PUNCT
ihlr-18810	737	23	and	and	CCONJ
ihlr-18810	737	24	achieve	achieve	VERB
ihlr-18810	737	25	similar	similar	ADJ
ihlr-18810	737	26	results	result	NOUN
ihlr-18810	737	27	.	.	PUNCT
ihlr-18810	738	1	288	288	NUM
ihlr-18810	738	2	even	even	ADV
ihlr-18810	738	3	within	within	ADP
ihlr-18810	738	4	the	the	DET
ihlr-18810	738	5	u.s	u.s	PROPN
ihlr-18810	738	6	.	.	PROPN
ihlr-18810	738	7	studies	study	NOUN
ihlr-18810	738	8	comparing	compare	VERB
ihlr-18810	738	9	the	the	DET
ihlr-18810	738	10	different	different	ADJ
ihlr-18810	738	11	healthcare	healthcare	NOUN
ihlr-18810	738	12	spending	spending	NOUN
ihlr-18810	738	13	rates	rate	NOUN
ihlr-18810	738	14	between	between	ADP
ihlr-18810	738	15	regions	region	NOUN
ihlr-18810	738	16	found	find	VERB
ihlr-18810	738	17	that	that	SCONJ
ihlr-18810	738	18	patients	patient	NOUN
ihlr-18810	738	19	of	of	ADP
ihlr-18810	738	20	the	the	DET
ihlr-18810	738	21	highest	high	ADJ
ihlr-18810	738	22	spending	spending	NOUN
ihlr-18810	738	23	hospitals	hospital	NOUN
ihlr-18810	738	24	were	be	AUX
ihlr-18810	738	25	2	2	NUM
ihlr-18810	738	26	-	-	SYM
ihlr-18810	738	27	6	6	NUM
ihlr-18810	738	28	%	%	NOUN
ihlr-18810	738	29	more	more	ADV
ihlr-18810	738	30	likely	likely	ADJ
ihlr-18810	738	31	to	to	PART
ihlr-18810	738	32	die	die	VERB
ihlr-18810	738	33	than	than	ADP
ihlr-18810	738	34	patients	patient	NOUN
ihlr-18810	738	35	receiving	receive	VERB
ihlr-18810	738	36	care	care	NOUN
ihlr-18810	738	37	at	at	ADP
ihlr-18810	738	38	the	the	DET
ihlr-18810	738	39	lowest	low	ADJ
ihlr-18810	738	40	spending	spending	NOUN
ihlr-18810	738	41	hospitals.289	hospitals.289	NOUN
ihlr-18810	738	42	all	all	PRON
ihlr-18810	738	43	of	of	ADP
ihlr-18810	738	44	this	this	DET
ihlr-18810	738	45	evidence	evidence	NOUN
ihlr-18810	738	46	shows	show	VERB
ihlr-18810	738	47	that	that	SCONJ
ihlr-18810	738	48	higher	high	ADJ
ihlr-18810	738	49	spending	spending	NOUN
ihlr-18810	738	50	and	and	CCONJ
ihlr-18810	738	51	higher	high	ADJ
ihlr-18810	738	52	utilization	utilization	NOUN
ihlr-18810	738	53	of	of	ADP
ihlr-18810	738	54	healthcare	healthcare	NOUN
ihlr-18810	738	55	does	do	AUX
ihlr-18810	738	56	not	not	PART
ihlr-18810	738	57	mean	mean	VERB
ihlr-18810	738	58	better	well	ADJ
ihlr-18810	738	59	health	health	NOUN
ihlr-18810	738	60	.	.	PUNCT
ihlr-18810	739	1	quite	quite	DET
ihlr-18810	739	2	the	the	DET
ihlr-18810	739	3	contrary	contrary	NOUN
ihlr-18810	739	4	,	,	PUNCT
ihlr-18810	739	5	advances	advance	NOUN
ihlr-18810	739	6	in	in	ADP
ihlr-18810	739	7	medical	medical	ADJ
ihlr-18810	739	8	technologies	technology	NOUN
ihlr-18810	739	9	result	result	VERB
ihlr-18810	739	10	in	in	ADP
ihlr-18810	739	11	an	an	DET
ihlr-18810	739	12	increase	increase	NOUN
ihlr-18810	739	13	in	in	ADP
ihlr-18810	739	14	the	the	DET
ihlr-18810	739	15	treatments	treatment	NOUN
ihlr-18810	739	16	available	available	ADJ
ihlr-18810	739	17	to	to	ADP
ihlr-18810	739	18	patients	patient	NOUN
ihlr-18810	739	19	,	,	PUNCT
ihlr-18810	739	20	and	and	CCONJ
ihlr-18810	739	21	a	a	DET
ihlr-18810	739	22	widening	widening	NOUN
ihlr-18810	739	23	of	of	ADP
ihlr-18810	739	24	the	the	DET
ihlr-18810	739	25	eligibility	eligibility	NOUN
ihlr-18810	739	26	criteria	criterion	NOUN
ihlr-18810	739	27	for	for	ADP
ihlr-18810	739	28	already	already	ADV
ihlr-18810	739	29	available	available	ADJ
ihlr-18810	739	30	procedures	procedure	NOUN
ihlr-18810	739	31	and	and	CCONJ
ihlr-18810	739	32	treatments	treatment	NOUN
ihlr-18810	739	33	,	,	PUNCT
ihlr-18810	739	34	290	290	NUM
ihlr-18810	739	35	which	which	PRON
ihlr-18810	739	36	can	can	AUX
ihlr-18810	739	37	lead	lead	VERB
ihlr-18810	739	38	to	to	ADP
ihlr-18810	739	39	greater	great	ADJ
ihlr-18810	739	40	utilization	utilization	NOUN
ihlr-18810	739	41	without	without	ADP
ihlr-18810	739	42	a	a	DET
ihlr-18810	739	43	notable	notable	ADJ
ihlr-18810	739	44	improvement	improvement	NOUN
ihlr-18810	739	45	in	in	ADP
ihlr-18810	739	46	patient	patient	ADJ
ihlr-18810	739	47	outcome.291	outcome.291	PROPN
ihlr-18810	739	48	283	283	NUM
ihlr-18810	739	49	global	global	ADJ
ihlr-18810	739	50	health	health	NOUN
ihlr-18810	739	51	observatory	observatory	NOUN
ihlr-18810	739	52	data	datum	NOUN
ihlr-18810	739	53	repository	repository	NOUN
ihlr-18810	739	54	:	:	PUNCT
ihlr-18810	739	55	united	united	PROPN
ihlr-18810	739	56	state	state	PROPN
ihlr-18810	739	57	of	of	ADP
ihlr-18810	739	58	america	america	PROPN
ihlr-18810	739	59	,	,	PUNCT
ihlr-18810	739	60	country	country	NOUN
ihlr-18810	739	61	statistics	statistic	NOUN
ihlr-18810	739	62	,	,	PUNCT
ihlr-18810	739	63	world	world	NOUN
ihlr-18810	739	64	health	health	NOUN
ihlr-18810	739	65	organization	organization	NOUN
ihlr-18810	739	66	(	(	PUNCT
ihlr-18810	739	67	2011	2011	NUM
ihlr-18810	739	68	)	)	PUNCT
ihlr-18810	739	69	,	,	PUNCT
ihlr-18810	739	70	http://apps.who.int/ghodata/?theme=country	http://apps.who.int/ghodata/?theme=country	NOUN
ihlr-18810	739	71	(	(	PUNCT
ihlr-18810	739	72	last	last	ADV
ihlr-18810	739	73	visited	visit	VERB
ihlr-18810	739	74	dec	dec	PROPN
ihlr-18810	739	75	.	.	PROPN
ihlr-18810	739	76	2	2	NUM
ihlr-18810	739	77	,	,	PUNCT
ihlr-18810	739	78	2012	2012	NUM
ihlr-18810	739	79	)	)	PUNCT
ihlr-18810	739	80	.	.	PUNCT
ihlr-18810	740	1	284	284	NUM
ihlr-18810	740	2	global	global	ADJ
ihlr-18810	740	3	health	health	NOUN
ihlr-18810	740	4	observatory	observatory	NOUN
ihlr-18810	740	5	data	datum	NOUN
ihlr-18810	740	6	repository	repository	NOUN
ihlr-18810	740	7	:	:	PUNCT
ihlr-18810	740	8	united	united	ADJ
ihlr-18810	740	9	kingdom	kingdom	PROPN
ihlr-18810	740	10	,	,	PUNCT
ihlr-18810	740	11	country	country	NOUN
ihlr-18810	740	12	statistics	statistic	NOUN
ihlr-18810	740	13	,	,	PUNCT
ihlr-18810	740	14	world	world	NOUN
ihlr-18810	740	15	health	health	NOUN
ihlr-18810	740	16	organization	organization	NOUN
ihlr-18810	740	17	(	(	PUNCT
ihlr-18810	740	18	2011	2011	NUM
ihlr-18810	740	19	)	)	PUNCT
ihlr-18810	740	20	,	,	PUNCT
ihlr-18810	740	21	http://	http://	PROPN
ihlr-18810	740	22	apps.who.int/ghodata/?theme=country	apps.who.int/ghodata/?theme=country	PROPN
ihlr-18810	740	23	(	(	PUNCT
ihlr-18810	740	24	last	last	ADV
ihlr-18810	740	25	visited	visit	VERB
ihlr-18810	740	26	dec	dec	PROPN
ihlr-18810	740	27	.	.	PROPN
ihlr-18810	740	28	2	2	NUM
ihlr-18810	740	29	,	,	PUNCT
ihlr-18810	740	30	2012	2012	NUM
ihlr-18810	740	31	)	)	PUNCT
ihlr-18810	740	32	.	.	PUNCT
ihlr-18810	741	1	285	285	NUM
ihlr-18810	741	2	global	global	ADJ
ihlr-18810	741	3	health	health	NOUN
ihlr-18810	741	4	observatory	observatory	NOUN
ihlr-18810	741	5	data	datum	NOUN
ihlr-18810	741	6	repository	repository	NOUN
ihlr-18810	741	7	.	.	PUNCT
ihlr-18810	741	8	*	*	PUNCT
ihlr-18810	741	9	france	france	PROPN
ihlr-18810	741	10	,	,	PUNCT
ihlr-18810	741	11	country	country	NOUN
ihlr-18810	741	12	statistics	statistic	NOUN
ihlr-18810	741	13	,	,	PUNCT
ihlr-18810	741	14	world	world	NOUN
ihlr-18810	741	15	health	health	NOUN
ihlr-18810	741	16	organization	organization	NOUN
ihlr-18810	741	17	(	(	PUNCT
ihlr-18810	741	18	2011	2011	NUM
ihlr-18810	741	19	)	)	PUNCT
ihlr-18810	741	20	,	,	PUNCT
ihlr-18810	741	21	http://apps.who	http://apps.who	PRON
ihlr-18810	741	22	.	.	PUNCT
ihlr-18810	742	1	int	int	NOUN
ihlr-18810	742	2	/	/	SYM
ihlr-18810	742	3	ghodata/?theme	ghodata/?theme	NOUN
ihlr-18810	742	4	=	=	NOUN
ihlr-18810	742	5	country	country	NOUN
ihlr-18810	742	6	.	.	PUNCT
ihlr-18810	743	1	286	286	NUM
ihlr-18810	743	2	see	see	VERB
ihlr-18810	743	3	howard	howard	PROPN
ihlr-18810	743	4	steven	steven	PROPN
ihlr-18810	743	5	friedman	friedman	PROPN
ihlr-18810	743	6	,	,	PUNCT
ihlr-18810	743	7	5	5	NUM
ihlr-18810	743	8	countries	country	NOUN
ihlr-18810	743	9	with	with	ADP
ihlr-18810	743	10	the	the	DET
ihlr-18810	743	11	longest	long	ADJ
ihlr-18810	743	12	life	life	NOUN
ihlr-18810	743	13	expectancy	expectancy	NOUN
ihlr-18810	743	14	:	:	PUNCT
ihlr-18810	743	15	oecd	oecd	PROPN
ihlr-18810	743	16	,	,	PUNCT
ihlr-18810	743	17	huffingtonpost.com	huffingtonpost.com	X
ihlr-18810	743	18	(	(	PUNCT
ihlr-18810	743	19	may	may	PROPN
ihlr-18810	743	20	27	27	NUM
ihlr-18810	743	21	,	,	PUNCT
ihlr-18810	743	22	2011	2011	NUM
ihlr-18810	743	23	)	)	PUNCT
ihlr-18810	743	24	http://	http://	PROPN
ihlr-18810	743	25	www.huffingtonpost.com/howard-steven-friedman/lifeexpectancy-b_867361.html#s284378&title=5_sweden_814	www.huffingtonpost.com/howard-steven-friedman/lifeexpectancy-b_867361.html#s284378&title=5_sweden_814	NOUN
ihlr-18810	743	26	.	.	PUNCT
ihlr-18810	744	1	287	287	NUM
ihlr-18810	744	2	global	global	ADJ
ihlr-18810	744	3	health	health	NOUN
ihlr-18810	744	4	observatory	observatory	NOUN
ihlr-18810	744	5	data	datum	NOUN
ihlr-18810	744	6	repository	repository	NOUN
ihlr-18810	744	7	:	:	PUNCT
ihlr-18810	744	8	japan	japan	PROPN
ihlr-18810	744	9	,	,	PUNCT
ihlr-18810	744	10	country	country	NOUN
ihlr-18810	744	11	statistics	statistic	NOUN
ihlr-18810	744	12	,	,	PUNCT
ihlr-18810	744	13	world	world	NOUN
ihlr-18810	744	14	health	health	NOUN
ihlr-18810	744	15	organization	organization	NOUN
ihlr-18810	744	16	(	(	PUNCT
ihlr-18810	744	17	2011	2011	NUM
ihlr-18810	744	18	)	)	PUNCT
ihlr-18810	744	19	,	,	PUNCT
ihlr-18810	744	20	http://apps.who	http://apps.who	PRON
ihlr-18810	744	21	.	.	PUNCT
ihlr-18810	745	1	int	int	NOUN
ihlr-18810	745	2	/	/	SYM
ihlr-18810	745	3	ghodata/?theme	ghodata/?theme	NOUN
ihlr-18810	745	4	=	=	NOUN
ihlr-18810	745	5	country	country	NOUN
ihlr-18810	745	6	.	.	PUNCT
ihlr-18810	746	1	288	288	NUM
ihlr-18810	746	2	iom	iom	PROPN
ihlr-18810	746	3	ce	ce	PROPN
ihlr-18810	746	4	,	,	PUNCT
ihlr-18810	746	5	supra	supra	PROPN
ihlr-18810	746	6	note	note	PROPN
ihlr-18810	746	7	244	244	NUM
ihlr-18810	746	8	,	,	PUNCT
ihlr-18810	746	9	at	at	ADP
ihlr-18810	746	10	1	1	NUM
ihlr-18810	746	11	.	.	PUNCT
ihlr-18810	746	12	289	289	NUM
ihlr-18810	746	13	shannon	shannon	PROPN
ihlr-18810	746	14	brownlee	brownlee	PROPN
ihlr-18810	746	15	,	,	PUNCT
ihlr-18810	746	16	overtreated	overtreate	VERB
ihlr-18810	746	17	:	:	PUNCT
ihlr-18810	746	18	why	why	SCONJ
ihlr-18810	746	19	too	too	ADV
ihlr-18810	746	20	much	much	ADJ
ihlr-18810	746	21	medicine	medicine	NOUN
ihlr-18810	746	22	is	be	AUX
ihlr-18810	746	23	making	make	VERB
ihlr-18810	746	24	us	we	PRON
ihlr-18810	746	25	sicker	sicker	VERB
ihlr-18810	746	26	and	and	CCONJ
ihlr-18810	746	27	poorer	poor	ADJ
ihlr-18810	746	28	50	50	NUM
ihlr-18810	746	29	(	(	PUNCT
ihlr-18810	746	30	2007	2007	NUM
ihlr-18810	746	31	)	)	PUNCT
ihlr-18810	746	32	.	.	PUNCT
ihlr-18810	747	1	290	290	NUM
ihlr-18810	747	2	ruud	ruud	PROPN
ihlr-18810	747	3	ter	ter	NOUN
ihlr-18810	747	4	meulen	meulen	PROPN
ihlr-18810	747	5	,	,	PUNCT
ihlr-18810	747	6	is	be	AUX
ihlr-18810	747	7	rationing	ration	VERB
ihlr-18810	747	8	the	the	DET
ihlr-18810	747	9	inevitable	inevitable	ADJ
ihlr-18810	747	10	consequence	consequence	NOUN
ihlr-18810	747	11	of	of	ADP
ihlr-18810	747	12	medicaladvance	medicaladvance	NOUN
ihlr-18810	747	13	.	.	PROPN
ihlr-18810	747	14	,	,	PUNCT
ihlr-18810	747	15	27	27	NUM
ihlr-18810	747	16	med	med	ADJ
ihlr-18810	747	17	.	.	PROPN
ihlr-18810	747	18	&	&	CCONJ
ihlr-18810	747	19	l.	l.	PROPN
ihlr-18810	747	20	71	71	NUM
ihlr-18810	747	21	,	,	PUNCT
ihlr-18810	747	22	75	75	NUM
ihlr-18810	747	23	(	(	PUNCT
ihlr-18810	747	24	2008	2008	NUM
ihlr-18810	747	25	)	)	PUNCT
ihlr-18810	747	26	.	.	PUNCT
ihlr-18810	748	1	291	291	NUM
ihlr-18810	748	2	brownlee	brownlee	PROPN
ihlr-18810	748	3	,	,	PUNCT
ihlr-18810	748	4	supra	supra	PROPN
ihlr-18810	748	5	note	note	NOUN
ihlr-18810	748	6	289	289	NUM
ihlr-18810	748	7	,	,	PUNCT
ihlr-18810	748	8	at	at	ADP
ihlr-18810	748	9	113	113	NUM
ihlr-18810	748	10	.	.	PUNCT
ihlr-18810	748	11	168	168	NUM
ihlr-18810	748	12	vol	vol	NOUN
ihlr-18810	748	13	.	.	PUNCT
ihlr-18810	749	1	10	10	NUM
ihlr-18810	749	2	:	:	SYM
ihlr-18810	749	3	1	1	NUM
ihlr-18810	749	4	510(k	510(k	NUM
ihlr-18810	749	5	)	)	PUNCT
ihlr-18810	749	6	clearance	clearance	NOUN
ihlr-18810	749	7	even	even	ADV
ihlr-18810	749	8	in	in	ADP
ihlr-18810	749	9	light	light	NOUN
ihlr-18810	749	10	of	of	ADP
ihlr-18810	749	11	all	all	PRON
ihlr-18810	749	12	of	of	ADP
ihlr-18810	749	13	these	these	DET
ihlr-18810	749	14	facts	fact	NOUN
ihlr-18810	749	15	,	,	PUNCT
ihlr-18810	749	16	it	it	PRON
ihlr-18810	749	17	may	may	AUX
ihlr-18810	749	18	be	be	AUX
ihlr-18810	749	19	easy	easy	ADJ
ihlr-18810	749	20	to	to	PART
ihlr-18810	749	21	wonder	wonder	VERB
ihlr-18810	749	22	why	why	SCONJ
ihlr-18810	749	23	devices	device	NOUN
ihlr-18810	749	24	should	should	AUX
ihlr-18810	749	25	have	have	VERB
ihlr-18810	749	26	a	a	DET
ihlr-18810	749	27	separate	separate	ADJ
ihlr-18810	749	28	approval	approval	NOUN
ihlr-18810	749	29	process	process	NOUN
ihlr-18810	749	30	at	at	ADV
ihlr-18810	749	31	all	all	ADV
ihlr-18810	749	32	.	.	PUNCT
ihlr-18810	750	1	the	the	DET
ihlr-18810	750	2	fda	fda	PROPN
ihlr-18810	750	3	regulates	regulate	VERB
ihlr-18810	750	4	pharmaceutical	pharmaceutical	ADJ
ihlr-18810	750	5	drugs	drug	NOUN
ihlr-18810	750	6	as	as	ADV
ihlr-18810	750	7	well	well	ADV
ihlr-18810	750	8	as	as	ADP
ihlr-18810	750	9	medical	medical	ADJ
ihlr-18810	750	10	devices	device	NOUN
ihlr-18810	750	11	;	;	PUNCT
ihlr-18810	750	12	perhaps	perhaps	ADV
ihlr-18810	750	13	efficiencies	efficiency	NOUN
ihlr-18810	750	14	could	could	AUX
ihlr-18810	750	15	be	be	AUX
ihlr-18810	750	16	created	create	VERB
ihlr-18810	750	17	within	within	ADP
ihlr-18810	750	18	the	the	DET
ihlr-18810	750	19	agency	agency	NOUN
ihlr-18810	750	20	itself	itself	PRON
ihlr-18810	750	21	by	by	ADP
ihlr-18810	750	22	using	use	VERB
ihlr-18810	750	23	a	a	DET
ihlr-18810	750	24	single	single	ADJ
ihlr-18810	750	25	regulatory	regulatory	ADJ
ihlr-18810	750	26	pathway	pathway	NOUN
ihlr-18810	750	27	by	by	ADP
ihlr-18810	750	28	requiring	require	VERB
ihlr-18810	750	29	all	all	DET
ihlr-18810	750	30	medical	medical	ADJ
ihlr-18810	750	31	devices	device	NOUN
ihlr-18810	750	32	to	to	PART
ihlr-18810	750	33	go	go	VERB
ihlr-18810	750	34	through	through	ADP
ihlr-18810	750	35	the	the	DET
ihlr-18810	750	36	full	full	ADJ
ihlr-18810	750	37	pma	pma	NOUN
ihlr-18810	750	38	process	process	NOUN
ihlr-18810	750	39	,	,	PUNCT
ihlr-18810	750	40	like	like	SCONJ
ihlr-18810	750	41	pharmaceuticals	pharmaceutical	NOUN
ihlr-18810	750	42	must	must	AUX
ihlr-18810	750	43	.	.	PUNCT
ihlr-18810	751	1	this	this	PRON
ihlr-18810	751	2	would	would	AUX
ihlr-18810	751	3	not	not	PART
ihlr-18810	751	4	be	be	AUX
ihlr-18810	751	5	the	the	DET
ihlr-18810	751	6	answer	answer	NOUN
ihlr-18810	751	7	,	,	PUNCT
ihlr-18810	751	8	however	however	ADV
ihlr-18810	751	9	,	,	PUNCT
ihlr-18810	751	10	because	because	SCONJ
ihlr-18810	751	11	there	there	PRON
ihlr-18810	751	12	are	be	VERB
ihlr-18810	751	13	significant	significant	ADJ
ihlr-18810	751	14	differences	difference	NOUN
ihlr-18810	751	15	between	between	ADP
ihlr-18810	751	16	drugs	drug	NOUN
ihlr-18810	751	17	and	and	CCONJ
ihlr-18810	751	18	devices	device	NOUN
ihlr-18810	751	19	.	.	PUNCT
ihlr-18810	752	1	for	for	ADP
ihlr-18810	752	2	one	one	NUM
ihlr-18810	752	3	thing	thing	NOUN
ihlr-18810	752	4	,	,	PUNCT
ihlr-18810	752	5	drugs	drug	NOUN
ihlr-18810	752	6	have	have	VERB
ihlr-18810	752	7	longer	long	ADJ
ihlr-18810	752	8	product	product	NOUN
ihlr-18810	752	9	life	life	NOUN
ihlr-18810	752	10	cycles	cycle	NOUN
ihlr-18810	752	11	than	than	SCONJ
ihlr-18810	752	12	devices	device	NOUN
ihlr-18810	752	13	do	do	VERB
ihlr-18810	752	14	.	.	PUNCT
ihlr-18810	753	1	292	292	NUM
ihlr-18810	753	2	this	this	PRON
ihlr-18810	753	3	is	be	AUX
ihlr-18810	753	4	because	because	SCONJ
ihlr-18810	753	5	drugs	drug	NOUN
ihlr-18810	753	6	are	be	AUX
ihlr-18810	753	7	not	not	PART
ihlr-18810	753	8	likely	likely	ADJ
ihlr-18810	753	9	to	to	PART
ihlr-18810	753	10	change	change	VERB
ihlr-18810	753	11	over	over	ADP
ihlr-18810	753	12	time	time	NOUN
ihlr-18810	753	13	,	,	PUNCT
ihlr-18810	753	14	since	since	SCONJ
ihlr-18810	753	15	changes	change	NOUN
ihlr-18810	753	16	in	in	ADP
ihlr-18810	753	17	the	the	DET
ihlr-18810	753	18	molecular	molecular	ADJ
ihlr-18810	753	19	structure	structure	NOUN
ihlr-18810	753	20	of	of	ADP
ihlr-18810	753	21	the	the	DET
ihlr-18810	753	22	drug	drug	NOUN
ihlr-18810	753	23	creates	create	VERB
ihlr-18810	753	24	an	an	DET
ihlr-18810	753	25	entirely	entirely	ADV
ihlr-18810	753	26	new	new	ADJ
ihlr-18810	753	27	drug	drug	NOUN
ihlr-18810	753	28	that	that	PRON
ihlr-18810	753	29	needs	need	VERB
ihlr-18810	753	30	independent	independent	ADJ
ihlr-18810	753	31	fda	fda	PROPN
ihlr-18810	753	32	approval	approval	NOUN
ihlr-18810	753	33	.	.	PUNCT
ihlr-18810	754	1	in	in	ADP
ihlr-18810	754	2	contrast	contrast	NOUN
ihlr-18810	754	3	,	,	PUNCT
ihlr-18810	754	4	devices	device	NOUN
ihlr-18810	754	5	commonly	commonly	ADV
ihlr-18810	754	6	experience	experience	VERB
ihlr-18810	754	7	incremental	incremental	ADJ
ihlr-18810	754	8	changes	change	NOUN
ihlr-18810	754	9	over	over	ADP
ihlr-18810	754	10	time	time	NOUN
ihlr-18810	754	11	,	,	PUNCT
ihlr-18810	754	12	and	and	CCONJ
ihlr-18810	754	13	often	often	ADV
ihlr-18810	754	14	the	the	DET
ihlr-18810	754	15	technology	technology	NOUN
ihlr-18810	754	16	changes	change	VERB
ihlr-18810	754	17	rapidly	rapidly	ADV
ihlr-18810	754	18	.	.	PUNCT
ihlr-18810	755	1	293	293	NUM
ihlr-18810	755	2	this	this	PRON
ihlr-18810	755	3	constrains	constrain	VERB
ihlr-18810	755	4	the	the	DET
ihlr-18810	755	5	possibility	possibility	NOUN
ihlr-18810	755	6	of	of	ADP
ihlr-18810	755	7	conducting	conduct	VERB
ihlr-18810	755	8	long	long	ADJ
ihlr-18810	755	9	-	-	PUNCT
ihlr-18810	755	10	term	term	NOUN
ihlr-18810	755	11	premarket	premarket	NOUN
ihlr-18810	755	12	studies	study	NOUN
ihlr-18810	755	13	due	due	ADP
ihlr-18810	755	14	to	to	ADP
ihlr-18810	755	15	the	the	DET
ihlr-18810	755	16	likelihood	likelihood	NOUN
ihlr-18810	755	17	the	the	DET
ihlr-18810	755	18	device	device	NOUN
ihlr-18810	755	19	will	will	AUX
ihlr-18810	755	20	change	change	VERB
ihlr-18810	755	21	,	,	PUNCT
ihlr-18810	755	22	and	and	CCONJ
ihlr-18810	755	23	consequently	consequently	ADV
ihlr-18810	755	24	makes	make	VERB
ihlr-18810	755	25	it	it	PRON
ihlr-18810	755	26	difficult	difficult	ADJ
ihlr-18810	755	27	to	to	PART
ihlr-18810	755	28	study	study	VERB
ihlr-18810	755	29	,	,	PUNCT
ihlr-18810	755	30	or	or	CCONJ
ihlr-18810	755	31	even	even	ADV
ihlr-18810	755	32	detect	detect	VERB
ihlr-18810	755	33	,	,	PUNCT
ihlr-18810	755	34	risks	risk	NOUN
ihlr-18810	755	35	that	that	PRON
ihlr-18810	755	36	emerge	emerge	VERB
ihlr-18810	755	37	slowly	slowly	ADV
ihlr-18810	755	38	from	from	ADP
ihlr-18810	755	39	device	device	NOUN
ihlr-18810	755	40	use.2	use.2	ADJ
ihlr-18810	755	41	94	94	NUM
ihlr-18810	755	42	furthermore	furthermore	ADV
ihlr-18810	755	43	,	,	PUNCT
ihlr-18810	755	44	drugs	drug	NOUN
ihlr-18810	755	45	may	may	AUX
ihlr-18810	755	46	be	be	AUX
ihlr-18810	755	47	used	use	VERB
ihlr-18810	755	48	by	by	ADP
ihlr-18810	755	49	potentially	potentially	ADV
ihlr-18810	755	50	millions	million	NOUN
ihlr-18810	755	51	of	of	ADP
ihlr-18810	755	52	consumers	consumer	NOUN
ihlr-18810	755	53	,	,	PUNCT
ihlr-18810	755	54	while	while	SCONJ
ihlr-18810	755	55	devices	device	NOUN
ihlr-18810	755	56	are	be	AUX
ihlr-18810	755	57	used	use	VERB
ihlr-18810	755	58	by	by	ADP
ihlr-18810	755	59	a	a	DET
ihlr-18810	755	60	comparatively	comparatively	ADV
ihlr-18810	755	61	small	small	ADJ
ihlr-18810	755	62	number	number	NOUN
ihlr-18810	755	63	of	of	ADP
ihlr-18810	755	64	patients	patient	NOUN
ihlr-18810	755	65	.	.	PUNCT
ihlr-18810	756	1	295	295	NUM
ihlr-18810	756	2	the	the	DET
ihlr-18810	756	3	limited	limited	ADJ
ihlr-18810	756	4	number	number	NOUN
ihlr-18810	756	5	of	of	ADP
ihlr-18810	756	6	device	device	NOUN
ihlr-18810	756	7	users	user	NOUN
ihlr-18810	756	8	impedes	impede	VERB
ihlr-18810	756	9	the	the	DET
ihlr-18810	756	10	ability	ability	NOUN
ihlr-18810	756	11	of	of	ADP
ihlr-18810	756	12	researchers	researcher	NOUN
ihlr-18810	756	13	to	to	PART
ihlr-18810	756	14	conduct	conduct	VERB
ihlr-18810	756	15	randomized	randomize	VERB
ihlr-18810	756	16	controlled	control	VERB
ihlr-18810	756	17	studies	study	NOUN
ihlr-18810	756	18	in	in	ADP
ihlr-18810	756	19	an	an	DET
ihlr-18810	756	20	effort	effort	NOUN
ihlr-18810	756	21	to	to	PART
ihlr-18810	756	22	detect	detect	VERB
ihlr-18810	756	23	rare	rare	ADJ
ihlr-18810	756	24	adverse	adverse	ADJ
ihlr-18810	756	25	events	event	NOUN
ihlr-18810	756	26	or	or	CCONJ
ihlr-18810	756	27	differences	difference	NOUN
ihlr-18810	756	28	in	in	ADP
ihlr-18810	756	29	effectiveness	effectiveness	NOUN
ihlr-18810	756	30	between	between	ADP
ihlr-18810	756	31	products	product	NOUN
ihlr-18810	756	32	.	.	PUNCT
ihlr-18810	757	1	296	296	NUM
ihlr-18810	757	2	it	it	PRON
ihlr-18810	757	3	is	be	AUX
ihlr-18810	757	4	precisely	precisely	ADV
ihlr-18810	757	5	because	because	SCONJ
ihlr-18810	757	6	of	of	ADP
ihlr-18810	757	7	these	these	DET
ihlr-18810	757	8	differences	difference	NOUN
ihlr-18810	757	9	that	that	SCONJ
ihlr-18810	757	10	devices	device	NOUN
ihlr-18810	757	11	must	must	AUX
ihlr-18810	757	12	be	be	AUX
ihlr-18810	757	13	regulated	regulate	VERB
ihlr-18810	757	14	differently	differently	ADV
ihlr-18810	757	15	from	from	ADP
ihlr-18810	757	16	pharmaceuticals	pharmaceutical	NOUN
ihlr-18810	757	17	,	,	PUNCT
ihlr-18810	757	18	and	and	CCONJ
ihlr-18810	757	19	why	why	SCONJ
ihlr-18810	757	20	congress	congress	PROPN
ihlr-18810	757	21	passed	pass	VERB
ihlr-18810	757	22	legislation	legislation	NOUN
ihlr-18810	757	23	crafting	craft	VERB
ihlr-18810	757	24	two	two	NUM
ihlr-18810	757	25	different	different	ADJ
ihlr-18810	757	26	regulatory	regulatory	ADJ
ihlr-18810	757	27	frameworks	framework	NOUN
ihlr-18810	757	28	.	.	PUNCT
ihlr-18810	758	1	297	297	NUM
ihlr-18810	758	2	while	while	SCONJ
ihlr-18810	758	3	accepting	accept	VERB
ihlr-18810	758	4	the	the	DET
ihlr-18810	758	5	need	need	NOUN
ihlr-18810	758	6	to	to	PART
ihlr-18810	758	7	regulate	regulate	VERB
ihlr-18810	758	8	devices	device	NOUN
ihlr-18810	758	9	differently	differently	ADV
ihlr-18810	758	10	from	from	ADP
ihlr-18810	758	11	pharmaceuticals	pharmaceutical	NOUN
ihlr-18810	758	12	,	,	PUNCT
ihlr-18810	758	13	the	the	DET
ihlr-18810	758	14	argument	argument	NOUN
ihlr-18810	758	15	can	can	AUX
ihlr-18810	758	16	still	still	ADV
ihlr-18810	758	17	be	be	AUX
ihlr-18810	758	18	made	make	VERB
ihlr-18810	758	19	that	that	SCONJ
ihlr-18810	758	20	all	all	DET
ihlr-18810	758	21	devices	device	NOUN
ihlr-18810	758	22	should	should	AUX
ihlr-18810	758	23	be	be	AUX
ihlr-18810	758	24	required	require	VERB
ihlr-18810	758	25	to	to	PART
ihlr-18810	758	26	undergo	undergo	VERB
ihlr-18810	758	27	the	the	DET
ihlr-18810	758	28	more	more	ADV
ihlr-18810	758	29	intensive	intensive	ADJ
ihlr-18810	758	30	pma	pma	NOUN
ihlr-18810	758	31	process	process	NOUN
ihlr-18810	758	32	and	and	CCONJ
ihlr-18810	758	33	the	the	DET
ihlr-18810	758	34	510(k	510(k	PROPN
ihlr-18810	758	35	)	)	PUNCT
ihlr-18810	758	36	clearance	clearance	NOUN
ihlr-18810	758	37	should	should	AUX
ihlr-18810	758	38	be	be	AUX
ihlr-18810	758	39	eliminated	eliminate	VERB
ihlr-18810	758	40	altogether	altogether	ADV
ihlr-18810	758	41	,	,	PUNCT
ihlr-18810	758	42	in	in	ADP
ihlr-18810	758	43	the	the	DET
ihlr-18810	758	44	belief	belief	NOUN
ihlr-18810	758	45	that	that	SCONJ
ihlr-18810	758	46	this	this	PRON
ihlr-18810	758	47	would	would	AUX
ihlr-18810	758	48	ensure	ensure	VERB
ihlr-18810	758	49	medical	medical	ADJ
ihlr-18810	758	50	292	292	NUM
ihlr-18810	758	51	iom	iom	PROPN
ihlr-18810	758	52	report	report	NOUN
ihlr-18810	758	53	,	,	PUNCT
ihlr-18810	758	54	supra	supra	PROPN
ihlr-18810	758	55	note	note	NOUN
ihlr-18810	758	56	6	6	NUM
ihlr-18810	758	57	,	,	PUNCT
ihlr-18810	758	58	at	at	ADP
ihlr-18810	758	59	17	17	NUM
ihlr-18810	758	60	.	.	PUNCT
ihlr-18810	759	1	293	293	NUM
ihlr-18810	760	1	i	i	PRON
ihlr-18810	760	2	d.	d.	PROPN
ihlr-18810	760	3	294	294	NUM
ihlr-18810	761	1	i	i	PRON
ihlr-18810	761	2	d.	d.	PROPN
ihlr-18810	761	3	295	295	NUM
ihlr-18810	762	1	i	i	PRON
ihlr-18810	762	2	d.	d.	PROPN
ihlr-18810	762	3	296	296	NUM
ihlr-18810	762	4	i	i	PRON
ihlr-18810	762	5	d.	d.	PROPN
ihlr-18810	762	6	297	297	NUM
ihlr-18810	762	7	d.	d.	PROPN
ihlr-18810	762	8	at	at	ADP
ihlr-18810	762	9	17	17	NUM
ihlr-18810	762	10	-	-	SYM
ihlr-18810	762	11	18	18	NUM
ihlr-18810	762	12	.	.	PUNCT
ihlr-18810	762	13	2013	2013	NUM
ihlr-18810	762	14	169	169	NUM
ihlr-18810	762	15	indiana	indiana	PROPN
ihlr-18810	762	16	health	health	PROPN
ihlr-18810	762	17	law	law	PROPN
ihlr-18810	762	18	review	review	NOUN
ihlr-18810	762	19	devices	device	NOUN
ihlr-18810	762	20	are	be	AUX
ihlr-18810	762	21	safe	safe	ADJ
ihlr-18810	762	22	before	before	SCONJ
ihlr-18810	762	23	they	they	PRON
ihlr-18810	762	24	ever	ever	ADV
ihlr-18810	762	25	reach	reach	VERB
ihlr-18810	762	26	the	the	DET
ihlr-18810	762	27	market	market	NOUN
ihlr-18810	762	28	.	.	PUNCT
ihlr-18810	763	1	as	as	SCONJ
ihlr-18810	763	2	already	already	ADV
ihlr-18810	763	3	discussed	discuss	VERB
ihlr-18810	763	4	,	,	PUNCT
ihlr-18810	763	5	there	there	PRON
ihlr-18810	763	6	has	have	AUX
ihlr-18810	763	7	been	be	AUX
ihlr-18810	763	8	debate	debate	NOUN
ihlr-18810	763	9	about	about	ADP
ihlr-18810	763	10	the	the	DET
ihlr-18810	763	11	proper	proper	ADJ
ihlr-18810	763	12	balance	balance	NOUN
ihlr-18810	763	13	the	the	DET
ihlr-18810	763	14	fda	fda	PROPN
ihlr-18810	763	15	must	must	AUX
ihlr-18810	763	16	strike	strike	VERB
ihlr-18810	763	17	between	between	ADP
ihlr-18810	763	18	ensuring	ensure	VERB
ihlr-18810	763	19	adequate	adequate	ADJ
ihlr-18810	763	20	evaluation	evaluation	NOUN
ihlr-18810	763	21	of	of	ADP
ihlr-18810	763	22	devices	device	NOUN
ihlr-18810	763	23	before	before	ADP
ihlr-18810	763	24	being	be	AUX
ihlr-18810	763	25	approved	approve	VERB
ihlr-18810	763	26	for	for	ADP
ihlr-18810	763	27	market	market	NOUN
ihlr-18810	763	28	,	,	PUNCT
ihlr-18810	763	29	and	and	CCONJ
ihlr-18810	763	30	the	the	DET
ihlr-18810	763	31	need	need	NOUN
ihlr-18810	763	32	of	of	ADP
ihlr-18810	763	33	patients	patient	NOUN
ihlr-18810	763	34	to	to	PART
ihlr-18810	763	35	have	have	AUX
ihlr-18810	763	36	timely	timely	ADJ
ihlr-18810	763	37	access	access	NOUN
ihlr-18810	763	38	to	to	ADP
ihlr-18810	763	39	new	new	ADJ
ihlr-18810	763	40	medical	medical	ADJ
ihlr-18810	763	41	technologies	technology	NOUN
ihlr-18810	763	42	as	as	SCONJ
ihlr-18810	763	43	they	they	PRON
ihlr-18810	763	44	are	be	AUX
ihlr-18810	763	45	developed	develop	VERB
ihlr-18810	763	46	.	.	PUNCT
ihlr-18810	764	1	although	although	SCONJ
ihlr-18810	764	2	the	the	DET
ihlr-18810	764	3	sufficiency	sufficiency	NOUN
ihlr-18810	764	4	of	of	ADP
ihlr-18810	764	5	the	the	DET
ihlr-18810	764	6	510(k	510(k	PROPN
ihlr-18810	764	7	)	)	PUNCT
ihlr-18810	764	8	clearance	clearance	NOUN
ihlr-18810	764	9	process	process	NOUN
ihlr-18810	764	10	has	have	AUX
ihlr-18810	764	11	been	be	AUX
ihlr-18810	764	12	questioned	question	VERB
ihlr-18810	764	13	for	for	ADP
ihlr-18810	764	14	years	year	NOUN
ihlr-18810	764	15	,	,	PUNCT
ihlr-18810	764	16	it	it	PRON
ihlr-18810	764	17	is	be	AUX
ihlr-18810	764	18	obvious	obvious	ADJ
ihlr-18810	764	19	that	that	SCONJ
ihlr-18810	764	20	the	the	DET
ihlr-18810	764	21	process	process	NOUN
ihlr-18810	764	22	enables	enable	VERB
ihlr-18810	764	23	medical	medical	ADJ
ihlr-18810	764	24	device	device	NOUN
ihlr-18810	764	25	companies	company	NOUN
ihlr-18810	764	26	to	to	PART
ihlr-18810	764	27	get	get	VERB
ihlr-18810	764	28	their	their	PRON
ihlr-18810	764	29	devices	device	NOUN
ihlr-18810	764	30	to	to	PART
ihlr-18810	764	31	market	market	VERB
ihlr-18810	764	32	more	more	ADV
ihlr-18810	764	33	quickly	quickly	ADV
ihlr-18810	764	34	than	than	ADP
ihlr-18810	764	35	pma	pma	PROPN
ihlr-18810	764	36	review	review	NOUN
ihlr-18810	764	37	.	.	PUNCT
ihlr-18810	765	1	however	however	ADV
ihlr-18810	765	2	,	,	PUNCT
ihlr-18810	765	3	the	the	DET
ihlr-18810	765	4	more	more	ADV
ihlr-18810	765	5	intensive	intensive	ADJ
ihlr-18810	765	6	pma	pma	NOUN
ihlr-18810	765	7	process	process	NOUN
ihlr-18810	765	8	has	have	AUX
ihlr-18810	765	9	been	be	AUX
ihlr-18810	765	10	criticized	criticize	VERB
ihlr-18810	765	11	by	by	ADP
ihlr-18810	765	12	many	many	ADJ
ihlr-18810	765	13	in	in	ADP
ihlr-18810	765	14	the	the	DET
ihlr-18810	765	15	medical	medical	ADJ
ihlr-18810	765	16	device	device	NOUN
ihlr-18810	765	17	industry	industry	NOUN
ihlr-18810	765	18	as	as	ADP
ihlr-18810	765	19	hurting	hurt	VERB
ihlr-18810	765	20	innovation	innovation	NOUN
ihlr-18810	765	21	and	and	CCONJ
ihlr-18810	765	22	causing	cause	VERB
ihlr-18810	765	23	the	the	DET
ihlr-18810	765	24	u.s	u.s	PROPN
ihlr-18810	765	25	.	.	PROPN
ihlr-18810	765	26	medical	medical	ADJ
ihlr-18810	765	27	device	device	NOUN
ihlr-18810	765	28	industry	industry	NOUN
ihlr-18810	765	29	to	to	PART
ihlr-18810	765	30	lose	lose	VERB
ihlr-18810	765	31	its	its	PRON
ihlr-18810	765	32	competitive	competitive	ADJ
ihlr-18810	765	33	edge	edge	NOUN
ihlr-18810	765	34	overseas	overseas	ADV
ihlr-18810	765	35	.	.	PUNCT
ihlr-18810	766	1	298	298	NUM
ihlr-18810	766	2	patients	patient	NOUN
ihlr-18810	766	3	are	be	AUX
ihlr-18810	766	4	harmed	harm	VERB
ihlr-18810	766	5	by	by	ADP
ihlr-18810	766	6	these	these	DET
ihlr-18810	766	7	effects	effect	NOUN
ihlr-18810	766	8	as	as	ADV
ihlr-18810	766	9	well	well	ADV
ihlr-18810	766	10	,	,	PUNCT
ihlr-18810	766	11	since	since	SCONJ
ihlr-18810	766	12	many	many	ADJ
ihlr-18810	766	13	medical	medical	ADJ
ihlr-18810	766	14	device	device	NOUN
ihlr-18810	766	15	companies	company	NOUN
ihlr-18810	766	16	are	be	AUX
ihlr-18810	766	17	now	now	ADV
ihlr-18810	766	18	choosing	choose	VERB
ihlr-18810	766	19	to	to	PART
ihlr-18810	766	20	seek	seek	VERB
ihlr-18810	766	21	approval	approval	NOUN
ihlr-18810	766	22	for	for	ADP
ihlr-18810	766	23	new	new	ADJ
ihlr-18810	766	24	devices	device	NOUN
ihlr-18810	766	25	in	in	ADP
ihlr-18810	766	26	europe	europe	PROPN
ihlr-18810	766	27	first	first	ADV
ihlr-18810	766	28	due	due	ADP
ihlr-18810	766	29	to	to	ADP
ihlr-18810	766	30	the	the	DET
ihlr-18810	766	31	speed	speed	NOUN
ihlr-18810	766	32	with	with	ADP
ihlr-18810	766	33	which	which	PRON
ihlr-18810	766	34	the	the	DET
ihlr-18810	766	35	device	device	NOUN
ihlr-18810	766	36	can	can	AUX
ihlr-18810	766	37	be	be	AUX
ihlr-18810	766	38	approved	approve	VERB
ihlr-18810	766	39	for	for	ADP
ihlr-18810	766	40	market	market	NOUN
ihlr-18810	766	41	.	.	PUNCT
ihlr-18810	767	1	the	the	DET
ihlr-18810	767	2	difference	difference	NOUN
ihlr-18810	767	3	can	can	AUX
ihlr-18810	767	4	be	be	AUX
ihlr-18810	767	5	quite	quite	ADV
ihlr-18810	767	6	significant	significant	ADJ
ihlr-18810	767	7	;	;	PUNCT
ihlr-18810	767	8	a	a	DET
ihlr-18810	767	9	heart	heart	NOUN
ihlr-18810	767	10	valve	valve	VERB
ihlr-18810	767	11	able	able	ADJ
ihlr-18810	767	12	to	to	PART
ihlr-18810	767	13	be	be	AUX
ihlr-18810	767	14	installed	instal	VERB
ihlr-18810	767	15	through	through	ADP
ihlr-18810	767	16	a	a	DET
ihlr-18810	767	17	catheter	catheter	NOUN
ihlr-18810	767	18	,	,	PUNCT
ihlr-18810	767	19	saving	save	VERB
ihlr-18810	767	20	the	the	DET
ihlr-18810	767	21	patient	patient	NOUN
ihlr-18810	767	22	from	from	ADP
ihlr-18810	767	23	undergoing	undergo	VERB
ihlr-18810	767	24	open	open	ADJ
ihlr-18810	767	25	-	-	PUNCT
ihlr-18810	767	26	heart	heart	NOUN
ihlr-18810	767	27	surgery	surgery	NOUN
ihlr-18810	767	28	,	,	PUNCT
ihlr-18810	767	29	was	be	AUX
ihlr-18810	767	30	approved	approve	VERB
ihlr-18810	767	31	in	in	ADP
ihlr-18810	767	32	europe	europe	PROPN
ihlr-18810	767	33	more	more	ADJ
ihlr-18810	767	34	than	than	ADP
ihlr-18810	767	35	three	three	NUM
ihlr-18810	767	36	years	year	NOUN
ihlr-18810	767	37	earlier	early	ADV
ihlr-18810	767	38	than	than	ADP
ihlr-18810	767	39	in	in	ADP
ihlr-18810	767	40	the	the	DET
ihlr-18810	767	41	u.s.299	u.s.299	NOUN
ihlr-18810	767	42	there	there	PRON
ihlr-18810	767	43	are	be	VERB
ihlr-18810	767	44	a	a	DET
ihlr-18810	767	45	number	number	NOUN
ihlr-18810	767	46	of	of	ADP
ihlr-18810	767	47	differences	difference	NOUN
ihlr-18810	767	48	between	between	ADP
ihlr-18810	767	49	the	the	DET
ihlr-18810	767	50	review	review	NOUN
ihlr-18810	767	51	and	and	CCONJ
ihlr-18810	767	52	approval	approval	NOUN
ihlr-18810	767	53	processes	process	NOUN
ihlr-18810	767	54	for	for	ADP
ihlr-18810	767	55	medical	medical	ADJ
ihlr-18810	767	56	devices	device	NOUN
ihlr-18810	767	57	in	in	ADP
ihlr-18810	767	58	the	the	DET
ihlr-18810	767	59	u.s	u.s	PROPN
ihlr-18810	767	60	.	.	PROPN
ihlr-18810	767	61	and	and	CCONJ
ihlr-18810	767	62	europe	europe	PROPN
ihlr-18810	767	63	.	.	PUNCT
ihlr-18810	768	1	the	the	DET
ihlr-18810	768	2	european	european	PROPN
ihlr-18810	768	3	union	union	PROPN
ihlr-18810	768	4	's	's	PART
ihlr-18810	768	5	device	device	NOUN
ihlr-18810	768	6	regulation	regulation	NOUN
ihlr-18810	768	7	system	system	NOUN
ihlr-18810	768	8	is	be	AUX
ihlr-18810	768	9	governed	govern	VERB
ihlr-18810	768	10	by	by	ADP
ihlr-18810	768	11	three	three	NUM
ihlr-18810	768	12	directives	directive	NOUN
ihlr-18810	768	13	:	:	PUNCT
ihlr-18810	768	14	the	the	DET
ihlr-18810	768	15	medical	medical	ADJ
ihlr-18810	768	16	device	device	NOUN
ihlr-18810	768	17	directive	directive	NOUN
ihlr-18810	768	18	,	,	PUNCT
ihlr-18810	768	19	300	300	NUM
ihlr-18810	768	20	the	the	DET
ihlr-18810	768	21	in	in	ADV
ihlr-18810	768	22	-	-	PUNCT
ihlr-18810	768	23	vitro	vitro	X
ihlr-18810	768	24	diagnostic	diagnostic	ADJ
ihlr-18810	768	25	directive	directive	NOUN
ihlr-18810	768	26	,	,	PUNCT
ihlr-18810	768	27	301	301	NUM
ihlr-18810	768	28	and	and	CCONJ
ihlr-18810	768	29	the	the	DET
ihlr-18810	768	30	active	active	ADJ
ihlr-18810	768	31	implantable	implantable	ADJ
ihlr-18810	768	32	medical	medical	ADJ
ihlr-18810	768	33	device	device	NOUN
ihlr-18810	768	34	directive	directive	NOUN
ihlr-18810	768	35	.	.	PUNCT
ihlr-18810	769	1	302	302	NUM
ihlr-18810	769	2	each	each	PRON
ihlr-18810	769	3	lays	lay	VERB
ihlr-18810	769	4	out	out	ADP
ihlr-18810	769	5	guidelines	guideline	NOUN
ihlr-18810	769	6	for	for	ADP
ihlr-18810	769	7	the	the	DET
ihlr-18810	769	8	approval	approval	NOUN
ihlr-18810	769	9	of	of	ADP
ihlr-18810	769	10	their	their	PRON
ihlr-18810	769	11	respective	respective	ADJ
ihlr-18810	769	12	devices	device	NOUN
ihlr-18810	769	13	,	,	PUNCT
ihlr-18810	769	14	and	and	CCONJ
ihlr-18810	769	15	contains	contain	VERB
ihlr-18810	769	16	a	a	DET
ihlr-18810	769	17	list	list	NOUN
ihlr-18810	769	18	of	of	ADP
ihlr-18810	769	19	essential	essential	ADJ
ihlr-18810	769	20	requirements	requirement	NOUN
ihlr-18810	769	21	that	that	PRON
ihlr-18810	769	22	must	must	AUX
ihlr-18810	769	23	be	be	AUX
ihlr-18810	769	24	met	meet	VERB
ihlr-18810	769	25	by	by	ADP
ihlr-18810	769	26	each	each	DET
ihlr-18810	769	27	product	product	NOUN
ihlr-18810	769	28	within	within	ADP
ihlr-18810	769	29	its	its	PRON
ihlr-18810	769	30	scope	scope	NOUN
ihlr-18810	769	31	,	,	PUNCT
ihlr-18810	769	32	requirements	requirement	NOUN
ihlr-18810	769	33	that	that	PRON
ihlr-18810	769	34	can	can	AUX
ihlr-18810	769	35	298	298	NUM
ihlr-18810	769	36	pollack	pollack	VERB
ihlr-18810	769	37	,	,	PUNCT
ihlr-18810	769	38	supra	supra	PROPN
ihlr-18810	769	39	note	note	NOUN
ihlr-18810	769	40	219	219	NUM
ihlr-18810	769	41	.	.	PUNCT
ihlr-18810	770	1	299	299	NUM
ihlr-18810	771	1	i	i	NOUN
ihlr-18810	771	2	d.	d.	PROPN
ihlr-18810	771	3	300	300	NUM
ihlr-18810	771	4	eur	eur	NOUN
ihlr-18810	771	5	.	.	PUNCT
ihlr-18810	772	1	consult	consult	NOUN
ihlr-18810	772	2	.	.	PUNCT
ihlr-18810	773	1	ass	ass	PROPN
ihlr-18810	773	2	.	.	PROPN
ihlr-18810	773	3	,	,	PUNCT
ihlr-18810	773	4	council	council	NOUN
ihlr-18810	773	5	directive	directive	NOUN
ihlr-18810	773	6	93/42	93/42	NUM
ihlr-18810	773	7	/	/	SYM
ihlr-18810	773	8	eec	eec	PROPN
ihlr-18810	773	9	(	(	PUNCT
ihlr-18810	773	10	june	june	PROPN
ihlr-18810	773	11	14	14	NUM
ihlr-18810	773	12	,	,	PUNCT
ihlr-18810	773	13	1993	1993	NUM
ihlr-18810	773	14	)	)	PUNCT
ihlr-18810	773	15	,	,	PUNCT
ihlr-18810	773	16	available	available	ADJ
ihlr-18810	773	17	at	at	ADP
ihlr-18810	773	18	http://www.emergogroup.com/files/europeconsolidated-mdd-93-42-eec.pdf	http://www.emergogroup.com/files/europeconsolidated-mdd-93-42-eec.pdf	NOUN
ihlr-18810	773	19	.	.	PUNCT
ihlr-18810	774	1	301	301	NUM
ihlr-18810	774	2	eur	eur	ADJ
ihlr-18810	774	3	.	.	PUNCT
ihlr-18810	774	4	consult	consult	NOUN
ihlr-18810	774	5	.	.	PUNCT
ihlr-18810	775	1	ass	ass	PROPN
ihlr-18810	775	2	.	.	PROPN
ihlr-18810	775	3	,	,	PUNCT
ihlr-18810	775	4	council	council	NOUN
ihlr-18810	775	5	directive	directive	NOUN
ihlr-18810	775	6	98/79	98/79	NUM
ihlr-18810	775	7	/	/	SYM
ihlr-18810	775	8	ed	ed	NOUN
ihlr-18810	775	9	(	(	PUNCT
ihlr-18810	775	10	oct	oct	PROPN
ihlr-18810	775	11	.	.	PROPN
ihlr-18810	775	12	27	27	NUM
ihlr-18810	775	13	,	,	PUNCT
ihlr-18810	775	14	1998	1998	NUM
ihlr-18810	775	15	)	)	PUNCT
ihlr-18810	775	16	,	,	PUNCT
ihlr-18810	775	17	available	available	ADJ
ihlr-18810	775	18	at	at	ADP
ihlr-18810	775	19	http://www.emergogroup.com/files/in-vitro-diagnosticsdirective-98-79-ec-v2.pdf	http://www.emergogroup.com/files/in-vitro-diagnosticsdirective-98-79-ec-v2.pdf	PROPN
ihlr-18810	775	20	.	.	PUNCT
ihlr-18810	776	1	302	302	NUM
ihlr-18810	776	2	eur	eur	NOUN
ihlr-18810	776	3	.	.	PUNCT
ihlr-18810	776	4	consult	consult	NOUN
ihlr-18810	776	5	.	.	PUNCT
ihlr-18810	777	1	ass	ass	PROPN
ihlr-18810	777	2	.	.	PROPN
ihlr-18810	777	3	,	,	PUNCT
ihlr-18810	777	4	council	council	NOUN
ihlr-18810	777	5	directive	directive	NOUN
ihlr-18810	777	6	90/385	90/385	NUM
ihlr-18810	777	7	/	/	SYM
ihlr-18810	777	8	eec	eec	PROPN
ihlr-18810	777	9	(	(	PUNCT
ihlr-18810	777	10	june	june	PROPN
ihlr-18810	777	11	20	20	NUM
ihlr-18810	777	12	,	,	PUNCT
ihlr-18810	777	13	1990	1990	NUM
ihlr-18810	777	14	)	)	PUNCT
ihlr-18810	777	15	,	,	PUNCT
ihlr-18810	777	16	available	available	ADJ
ihlr-18810	777	17	at	at	ADP
ihlr-18810	777	18	http://www.emergogroup.com/files/europeconsolidated-90-385-eec.pdf	http://www.emergogroup.com/files/europeconsolidated-90-385-eec.pdf	PROPN
ihlr-18810	777	19	.	.	PUNCT
ihlr-18810	778	1	170	170	NUM
ihlr-18810	778	2	vol	vol	NOUN
ihlr-18810	778	3	.	.	PUNCT
ihlr-18810	779	1	10:1	10:1	NUM
ihlr-18810	779	2	510(k	510(k	NUM
ihlr-18810	779	3	)	)	PUNCT
ihlr-18810	779	4	clearance	clearance	NOUN
ihlr-18810	779	5	be	be	AUX
ihlr-18810	779	6	generally	generally	ADV
ihlr-18810	779	7	classified	classify	VERB
ihlr-18810	779	8	as	as	ADP
ihlr-18810	779	9	either	either	CCONJ
ihlr-18810	779	10	general	general	ADJ
ihlr-18810	779	11	requirements	requirement	NOUN
ihlr-18810	779	12	for	for	ADP
ihlr-18810	779	13	safety	safety	NOUN
ihlr-18810	779	14	and	and	CCONJ
ihlr-18810	779	15	performance	performance	NOUN
ihlr-18810	779	16	applicable	applicable	ADJ
ihlr-18810	779	17	to	to	ADP
ihlr-18810	779	18	all	all	DET
ihlr-18810	779	19	devices	device	NOUN
ihlr-18810	779	20	,	,	PUNCT
ihlr-18810	779	21	303	303	NUM
ihlr-18810	779	22	or	or	CCONJ
ihlr-18810	779	23	specific	specific	ADJ
ihlr-18810	779	24	technical	technical	ADJ
ihlr-18810	779	25	design	design	NOUN
ihlr-18810	779	26	and	and	CCONJ
ihlr-18810	779	27	manufacturing	manufacturing	NOUN
ihlr-18810	779	28	requirements	requirement	NOUN
ihlr-18810	779	29	applicable	applicable	ADJ
ihlr-18810	779	30	to	to	ADP
ihlr-18810	779	31	certain	certain	ADJ
ihlr-18810	779	32	types	type	NOUN
ihlr-18810	779	33	of	of	ADP
ihlr-18810	779	34	devices	device	NOUN
ihlr-18810	779	35	.	.	PUNCT
ihlr-18810	780	1	304	304	NUM
ihlr-18810	780	2	the	the	DET
ihlr-18810	780	3	approval	approval	NOUN
ihlr-18810	780	4	system	system	NOUN
ihlr-18810	780	5	operates	operate	VERB
ihlr-18810	780	6	in	in	ADP
ihlr-18810	780	7	a	a	DET
ihlr-18810	780	8	decentralized	decentralized	ADJ
ihlr-18810	780	9	fashion	fashion	NOUN
ihlr-18810	780	10	,	,	PUNCT
ihlr-18810	780	11	as	as	SCONJ
ihlr-18810	780	12	countries	country	NOUN
ihlr-18810	780	13	coordinate	coordinate	VERB
ihlr-18810	780	14	their	their	PRON
ihlr-18810	780	15	own	own	ADJ
ihlr-18810	780	16	approval	approval	NOUN
ihlr-18810	780	17	system	system	NOUN
ihlr-18810	780	18	in	in	ADP
ihlr-18810	780	19	accordance	accordance	NOUN
ihlr-18810	780	20	with	with	ADP
ihlr-18810	780	21	the	the	DET
ihlr-18810	780	22	directives	directive	NOUN
ihlr-18810	780	23	.	.	PUNCT
ihlr-18810	781	1	each	each	DET
ihlr-18810	781	2	country	country	NOUN
ihlr-18810	781	3	's	's	PART
ihlr-18810	781	4	competent	competent	ADJ
ihlr-18810	781	5	authority	authority	NOUN
ihlr-18810	781	6	certifies	certifie	NOUN
ihlr-18810	781	7	for	for	ADP
ihlr-18810	781	8	-	-	PUNCT
ihlr-18810	781	9	profit	profit	NOUN
ihlr-18810	781	10	"	"	PUNCT
ihlr-18810	781	11	notified	notify	VERB
ihlr-18810	781	12	bodies	body	NOUN
ihlr-18810	781	13	,	,	PUNCT
ihlr-18810	781	14	"	"	PUNCT
ihlr-18810	781	15	which	which	PRON
ihlr-18810	781	16	are	be	AUX
ihlr-18810	781	17	then	then	ADV
ihlr-18810	781	18	authorized	authorize	VERB
ihlr-18810	781	19	to	to	PART
ihlr-18810	781	20	approve	approve	VERB
ihlr-18810	781	21	a	a	DET
ihlr-18810	781	22	broad	broad	ADJ
ihlr-18810	781	23	variety	variety	NOUN
ihlr-18810	781	24	of	of	ADP
ihlr-18810	781	25	goods	good	NOUN
ihlr-18810	781	26	for	for	ADP
ihlr-18810	781	27	market	market	NOUN
ihlr-18810	781	28	,	,	PUNCT
ihlr-18810	781	29	including	include	VERB
ihlr-18810	781	30	medical	medical	ADJ
ihlr-18810	781	31	devices.305	devices.305	NOUN
ihlr-18810	781	32	these	these	DET
ihlr-18810	781	33	bodies	body	NOUN
ihlr-18810	781	34	will	will	AUX
ihlr-18810	781	35	accept	accept	VERB
ihlr-18810	781	36	and	and	CCONJ
ihlr-18810	781	37	certify	certify	VERB
ihlr-18810	781	38	new	new	ADJ
ihlr-18810	781	39	device	device	NOUN
ihlr-18810	781	40	applications	application	NOUN
ihlr-18810	781	41	,	,	PUNCT
ihlr-18810	781	42	and	and	CCONJ
ihlr-18810	781	43	may	may	AUX
ihlr-18810	781	44	request	request	VERB
ihlr-18810	781	45	clinical	clinical	ADJ
ihlr-18810	781	46	data	datum	NOUN
ihlr-18810	781	47	or	or	CCONJ
ihlr-18810	781	48	other	other	ADJ
ihlr-18810	781	49	information	information	NOUN
ihlr-18810	781	50	,	,	PUNCT
ihlr-18810	781	51	or	or	CCONJ
ihlr-18810	781	52	may	may	AUX
ihlr-18810	781	53	perform	perform	VERB
ihlr-18810	781	54	manufacturing	manufacture	VERB
ihlr-18810	781	55	quality	quality	NOUN
ihlr-18810	781	56	assessments	assessment	NOUN
ihlr-18810	781	57	in	in	ADP
ihlr-18810	781	58	making	make	VERB
ihlr-18810	781	59	its	its	PRON
ihlr-18810	781	60	determination	determination	NOUN
ihlr-18810	781	61	.	.	PUNCT
ihlr-18810	782	1	3	3	NUM
ihlr-18810	782	2	06	06	NUM
ihlr-18810	782	3	currently	currently	ADV
ihlr-18810	782	4	,	,	PUNCT
ihlr-18810	782	5	there	there	PRON
ihlr-18810	782	6	are	be	VERB
ihlr-18810	782	7	seventy	seventy	NUM
ihlr-18810	782	8	-	-	PUNCT
ihlr-18810	782	9	eight	eight	NUM
ihlr-18810	782	10	notified	notify	VERB
ihlr-18810	782	11	bodies	body	NOUN
ihlr-18810	782	12	,	,	PUNCT
ihlr-18810	782	13	among	among	ADP
ihlr-18810	782	14	thirty	thirty	NUM
ihlr-18810	782	15	countries	country	NOUN
ihlr-18810	782	16	,	,	PUNCT
ihlr-18810	782	17	authorized	authorize	VERB
ihlr-18810	782	18	to	to	PART
ihlr-18810	782	19	grant	grant	VERB
ihlr-18810	782	20	certification	certification	NOUN
ihlr-18810	782	21	and	and	CCONJ
ihlr-18810	782	22	approve	approve	VERB
ihlr-18810	782	23	medical	medical	ADJ
ihlr-18810	782	24	devices	device	NOUN
ihlr-18810	782	25	for	for	ADP
ihlr-18810	782	26	marketing	marketing	NOUN
ihlr-18810	782	27	in	in	ADP
ihlr-18810	782	28	the	the	DET
ihlr-18810	782	29	european	european	PROPN
ihlr-18810	782	30	union	union	PROPN
ihlr-18810	782	31	.	.	PUNCT
ihlr-18810	783	1	307	307	NUM
ihlr-18810	783	2	the	the	DET
ihlr-18810	783	3	medical	medical	ADJ
ihlr-18810	783	4	device	device	NOUN
ihlr-18810	783	5	approval	approval	NOUN
ihlr-18810	783	6	process	process	NOUN
ihlr-18810	783	7	in	in	ADP
ihlr-18810	783	8	the	the	DET
ihlr-18810	783	9	european	european	PROPN
ihlr-18810	783	10	union	union	PROPN
ihlr-18810	783	11	is	be	AUX
ihlr-18810	783	12	typically	typically	ADV
ihlr-18810	783	13	completed	complete	VERB
ihlr-18810	783	14	about	about	ADP
ihlr-18810	783	15	twentyone	twentyone	PROPN
ihlr-18810	783	16	months	month	NOUN
ihlr-18810	783	17	sooner	soon	ADV
ihlr-18810	783	18	than	than	SCONJ
ihlr-18810	783	19	in	in	ADP
ihlr-18810	783	20	the	the	DET
ihlr-18810	783	21	u.s.308	u.s.308	ADJ
ihlr-18810	783	22	critics	critic	NOUN
ihlr-18810	783	23	have	have	AUX
ihlr-18810	783	24	countered	counter	VERB
ihlr-18810	783	25	with	with	ADP
ihlr-18810	783	26	the	the	DET
ihlr-18810	783	27	argument	argument	NOUN
ihlr-18810	783	28	that	that	SCONJ
ihlr-18810	783	29	it	it	PRON
ihlr-18810	783	30	is	be	AUX
ihlr-18810	783	31	not	not	PART
ihlr-18810	783	32	that	that	SCONJ
ihlr-18810	783	33	the	the	DET
ihlr-18810	783	34	fda	fda	PROPN
ihlr-18810	783	35	's	's	PART
ihlr-18810	783	36	regulations	regulation	NOUN
ihlr-18810	783	37	are	be	AUX
ihlr-18810	783	38	too	too	ADV
ihlr-18810	783	39	stringent	stringent	ADJ
ihlr-18810	783	40	,	,	PUNCT
ihlr-18810	783	41	but	but	CCONJ
ihlr-18810	783	42	rather	rather	ADV
ihlr-18810	783	43	,	,	PUNCT
ihlr-18810	783	44	the	the	DET
ihlr-18810	783	45	european	european	PROPN
ihlr-18810	783	46	union	union	PROPN
ihlr-18810	783	47	's	's	PART
ihlr-18810	783	48	regulation	regulation	NOUN
ihlr-18810	783	49	of	of	ADP
ihlr-18810	783	50	medical	medical	ADJ
ihlr-18810	783	51	devices	device	NOUN
ihlr-18810	783	52	is	be	AUX
ihlr-18810	783	53	too	too	ADV
ihlr-18810	783	54	303	303	NUM
ihlr-18810	783	55	see	see	NOUN
ihlr-18810	783	56	eur	eur	PROPN
ihlr-18810	783	57	.	.	PUNCT
ihlr-18810	784	1	consult	consult	VERB
ihlr-18810	784	2	.	.	PUNCT
ihlr-18810	785	1	ass	ass	PROPN
ihlr-18810	785	2	.	.	PROPN
ihlr-18810	785	3	,	,	PUNCT
ihlr-18810	785	4	medical	medical	ADJ
ihlr-18810	785	5	device	device	NOUN
ihlr-18810	785	6	directive	directive	NOUN
ihlr-18810	785	7	,	,	PUNCT
ihlr-18810	785	8	article	article	NOUN
ihlr-18810	785	9	3	3	NUM
ihlr-18810	785	10	and	and	CCONJ
ihlr-18810	785	11	annex	annex	VERB
ihlr-18810	785	12	1	1	NUM
ihlr-18810	785	13	(	(	PUNCT
ihlr-18810	785	14	june	june	PROPN
ihlr-18810	785	15	14	14	NUM
ihlr-18810	785	16	,	,	PUNCT
ihlr-18810	785	17	1993	1993	NUM
ihlr-18810	785	18	)	)	PUNCT
ihlr-18810	785	19	,	,	PUNCT
ihlr-18810	785	20	available	available	ADJ
ihlr-18810	785	21	at	at	ADP
ihlr-18810	785	22	http://www.emergogroup.com/	http://www.emergogroup.com/	NOUN
ihlr-18810	785	23	files	file	NOUN
ihlr-18810	785	24	/	/	SYM
ihlr-18810	785	25	europe	europe	PROPN
ihlr-18810	785	26	-	-	PUNCT
ihlr-18810	785	27	consolidated	consolidate	VERB
ihlr-18810	785	28	-	-	PUNCT
ihlr-18810	785	29	mdd-93	mdd-93	NOUN
ihlr-18810	785	30	-	-	PUNCT
ihlr-18810	785	31	42	42	NUM
ihlr-18810	785	32	-	-	PUNCT
ihlr-18810	785	33	eec.pdf	eec.pdf	NOUN
ihlr-18810	785	34	.	.	PUNCT
ihlr-18810	786	1	304	304	NUM
ihlr-18810	786	2	i	i	PRON
ihlr-18810	786	3	d.	d.	PROPN
ihlr-18810	786	4	305	305	NUM
ihlr-18810	786	5	davis	davis	PROPN
ihlr-18810	786	6	,	,	PUNCT
ihlr-18810	786	7	supra	supra	PROPN
ihlr-18810	786	8	note	note	PROPN
ihlr-18810	786	9	221	221	NUM
ihlr-18810	786	10	,	,	PUNCT
ihlr-18810	786	11	at	at	ADP
ihlr-18810	786	12	2	2	NUM
ihlr-18810	786	13	.	.	SYM
ihlr-18810	786	14	306	306	NUM
ihlr-18810	787	1	i	i	PROPN
ihlr-18810	787	2	d	d	PROPN
ihlr-18810	787	3	,	,	PUNCT
ihlr-18810	787	4	307	307	NUM
ihlr-18810	787	5	enterprise	enterprise	NOUN
ihlr-18810	787	6	and	and	CCONJ
ihlr-18810	787	7	industry	industry	NOUN
ihlr-18810	787	8	:	:	PUNCT
ihlr-18810	788	1	nando	nando	PROPN
ihlr-18810	788	2	,	,	PUNCT
ihlr-18810	788	3	bodies	body	NOUN
ihlr-18810	788	4	,	,	PUNCT
ihlr-18810	788	5	european	european	PROPN
ihlr-18810	788	6	commission	commission	PROPN
ihlr-18810	788	7	,	,	PUNCT
ihlr-18810	788	8	http://ec.europa.eulenterprise/newapproach/nando/index	http://ec.europa.eulenterprise/newapproach/nando/index	PROPN
ihlr-18810	788	9	.	.	PUNCT
ihlr-18810	788	10	cfm?fuseaction	cfm?fuseaction	NOUN
ihlr-18810	788	11	=	=	SYM
ihlr-18810	788	12	directive.notifiedbody&dirid=13&type	directive.notifiedbody&dirid=13&type	PROPN
ihlr-18810	788	13	-	-	PUNCT
ihlr-18810	788	14	dir	dir	NOUN
ihlr-18810	788	15	=	=	NOUN
ihlr-18810	788	16	no%2ocpd	no%2ocpd	PROPN
ihlr-18810	788	17	&	&	CCONJ
ihlr-18810	788	18	pro	pro	ADJ
ihlr-18810	788	19	id=99999&prc_id=99999&ann_id=99999&prcanx=99999	id=99999&prc_id=99999&ann_id=99999&prcanx=99999	PROPN
ihlr-18810	788	20	(	(	PUNCT
ihlr-18810	788	21	last	last	ADV
ihlr-18810	788	22	visited	visit	VERB
ihlr-18810	788	23	dec	dec	PROPN
ihlr-18810	788	24	.	.	PROPN
ihlr-18810	788	25	2	2	NUM
ihlr-18810	788	26	,	,	PUNCT
ihlr-18810	788	27	2012	2012	NUM
ihlr-18810	788	28	)	)	PUNCT
ihlr-18810	788	29	.	.	PUNCT
ihlr-18810	789	1	308	308	NUM
ihlr-18810	789	2	todd	todd	NOUN
ihlr-18810	789	3	v.	v.	ADP
ihlr-18810	789	4	dhavale	dhavale	PROPN
ihlr-18810	789	5	,	,	PUNCT
ihlr-18810	789	6	evaluation	evaluation	NOUN
ihlr-18810	789	7	of	of	ADP
ihlr-18810	789	8	the	the	DET
ihlr-18810	789	9	medical	medical	ADJ
ihlr-18810	789	10	device	device	NOUN
ihlr-18810	789	11	approval	approval	NOUN
ihlr-18810	789	12	lag	lag	NOUN
ihlr-18810	789	13	between	between	ADP
ihlr-18810	789	14	the	the	DET
ihlr-18810	789	15	united	united	PROPN
ihlr-18810	789	16	states	states	PROPN
ihlr-18810	789	17	and	and	CCONJ
ihlr-18810	789	18	the	the	DET
ihlr-18810	789	19	european	european	PROPN
ihlr-18810	789	20	union	union	PROPN
ihlr-18810	789	21	35	35	NUM
ihlr-18810	789	22	(	(	PUNCT
ihlr-18810	789	23	2011	2011	NUM
ihlr-18810	789	24	)	)	PUNCT
ihlr-18810	789	25	,	,	PUNCT
ihlr-18810	789	26	available	available	ADJ
ihlr-18810	789	27	at	at	ADP
ihlr-18810	789	28	http://dspace.mit.edul	http://dspace.mit.edul	PROPN
ihlr-18810	789	29	handle/1721.1/68465	handle/1721.1/68465	PROPN
ihlr-18810	789	30	.	.	PUNCT
ihlr-18810	790	1	in	in	ADP
ihlr-18810	790	2	a	a	DET
ihlr-18810	790	3	study	study	NOUN
ihlr-18810	790	4	of	of	ADP
ihlr-18810	790	5	twenty	twenty	NUM
ihlr-18810	790	6	years	year	NOUN
ihlr-18810	790	7	of	of	ADP
ihlr-18810	790	8	approval	approval	NOUN
ihlr-18810	790	9	data	datum	NOUN
ihlr-18810	790	10	for	for	ADP
ihlr-18810	790	11	135	135	NUM
ihlr-18810	790	12	coronary	coronary	ADJ
ihlr-18810	790	13	stent	stent	NOUN
ihlr-18810	790	14	,	,	PUNCT
ihlr-18810	790	15	icd	icd	PROPN
ihlr-18810	790	16	and	and	CCONJ
ihlr-18810	790	17	spine	spine	ADJ
ihlr-18810	790	18	class	class	PROPN
ihlr-18810	790	19	iii	iii	PROPN
ihlr-18810	790	20	medical	medical	ADJ
ihlr-18810	790	21	devices	device	NOUN
ihlr-18810	790	22	,	,	PUNCT
ihlr-18810	790	23	it	it	PRON
ihlr-18810	790	24	was	be	AUX
ihlr-18810	790	25	found	find	VERB
ihlr-18810	790	26	that	that	SCONJ
ihlr-18810	790	27	the	the	DET
ihlr-18810	790	28	total	total	ADJ
ihlr-18810	790	29	average	average	ADJ
ihlr-18810	790	30	approval	approval	NOUN
ihlr-18810	790	31	lag	lag	NOUN
ihlr-18810	790	32	for	for	ADP
ihlr-18810	790	33	these	these	DET
ihlr-18810	790	34	devices	device	NOUN
ihlr-18810	790	35	in	in	ADP
ihlr-18810	790	36	the	the	DET
ihlr-18810	790	37	united	united	PROPN
ihlr-18810	790	38	states	states	PROPN
ihlr-18810	790	39	was	be	AUX
ihlr-18810	790	40	over	over	ADP
ihlr-18810	790	41	twenty	twenty	NUM
ihlr-18810	790	42	-	-	PUNCT
ihlr-18810	790	43	one	one	NUM
ihlr-18810	790	44	months	month	NOUN
ihlr-18810	790	45	behind	behind	ADP
ihlr-18810	790	46	the	the	DET
ihlr-18810	790	47	european	european	PROPN
ihlr-18810	790	48	union	union	PROPN
ihlr-18810	790	49	.	.	PUNCT
ihlr-18810	791	1	of	of	ADP
ihlr-18810	791	2	the	the	DET
ihlr-18810	791	3	135	135	NUM
ihlr-18810	791	4	devices	device	NOUN
ihlr-18810	791	5	studied	study	VERB
ihlr-18810	791	6	,	,	PUNCT
ihlr-18810	791	7	thirtyfour	thirtyfour	PROPN
ihlr-18810	791	8	were	be	AUX
ihlr-18810	791	9	approved	approve	VERB
ihlr-18810	791	10	in	in	ADP
ihlr-18810	791	11	the	the	DET
ihlr-18810	791	12	european	european	PROPN
ihlr-18810	791	13	union	union	PROPN
ihlr-18810	791	14	but	but	CCONJ
ihlr-18810	791	15	not	not	PART
ihlr-18810	791	16	yet	yet	ADV
ihlr-18810	791	17	approved	approve	VERB
ihlr-18810	791	18	in	in	ADP
ihlr-18810	791	19	the	the	DET
ihlr-18810	791	20	united	united	PROPN
ihlr-18810	791	21	states	states	PROPN
ihlr-18810	791	22	.	.	PUNCT
ihlr-18810	792	1	2013	2013	NUM
ihlr-18810	792	2	171	171	NUM
ihlr-18810	792	3	indiana	indiana	PROPN
ihlr-18810	792	4	health	health	PROPN
ihlr-18810	792	5	law	law	PROPN
ihlr-18810	792	6	review	review	NOUN
ihlr-18810	792	7	lenient.309	lenient.309	NOUN
ihlr-18810	792	8	for	for	ADP
ihlr-18810	792	9	example	example	NOUN
ihlr-18810	792	10	,	,	PUNCT
ihlr-18810	792	11	"	"	PUNCT
ihlr-18810	792	12	a	a	DET
ihlr-18810	792	13	breast	breast	NOUN
ihlr-18810	792	14	implant	implant	NOUN
ihlr-18810	792	15	,	,	PUNCT
ihlr-18810	792	16	a	a	DET
ihlr-18810	792	17	lung	lung	NOUN
ihlr-18810	792	18	sealant	sealant	NOUN
ihlr-18810	792	19	and	and	CCONJ
ihlr-18810	792	20	an	an	DET
ihlr-18810	792	21	implant	implant	NOUN
ihlr-18810	792	22	for	for	ADP
ihlr-18810	792	23	elbow	elbow	NOUN
ihlr-18810	792	24	fractures	fracture	NOUN
ihlr-18810	792	25	were	be	AUX
ihlr-18810	792	26	approved	approve	VERB
ihlr-18810	792	27	in	in	ADP
ihlr-18810	792	28	europe	europe	PROPN
ihlr-18810	792	29	but	but	CCONJ
ihlr-18810	792	30	not	not	PART
ihlr-18810	792	31	in	in	ADP
ihlr-18810	792	32	the	the	DET
ihlr-18810	792	33	u.s	u.s	PROPN
ihlr-18810	792	34	.	.	PROPN
ihlr-18810	792	35	,	,	PUNCT
ihlr-18810	792	36	and	and	CCONJ
ihlr-18810	792	37	then	then	ADV
ihlr-18810	792	38	had	have	VERB
ihlr-18810	792	39	to	to	PART
ihlr-18810	792	40	be	be	AUX
ihlr-18810	792	41	taken	take	VERB
ihlr-18810	792	42	off	off	ADP
ihlr-18810	792	43	the	the	DET
ihlr-18810	792	44	market	market	NOUN
ihlr-18810	792	45	in	in	ADP
ihlr-18810	792	46	europe	europe	PROPN
ihlr-18810	792	47	for	for	ADP
ihlr-18810	792	48	safety	safety	NOUN
ihlr-18810	792	49	reasons	reason	NOUN
ihlr-18810	792	50	.	.	PUNCT
ihlr-18810	793	1	"310	"310	PROPN
ihlr-18810	793	2	although	although	SCONJ
ihlr-18810	793	3	re	re	NOUN
ihlr-18810	793	4	-	-	NOUN
ihlr-18810	793	5	calls	call	NOUN
ihlr-18810	793	6	have	have	AUX
ihlr-18810	793	7	in	in	ADP
ihlr-18810	793	8	fact	fact	NOUN
ihlr-18810	793	9	occurred	occur	VERB
ihlr-18810	793	10	,	,	PUNCT
ihlr-18810	793	11	studies	study	NOUN
ihlr-18810	793	12	suggest	suggest	VERB
ihlr-18810	793	13	the	the	DET
ihlr-18810	793	14	rates	rate	NOUN
ihlr-18810	793	15	of	of	ADP
ihlr-18810	793	16	recalls	recall	NOUN
ihlr-18810	793	17	in	in	ADP
ihlr-18810	793	18	europe	europe	PROPN
ihlr-18810	793	19	and	and	CCONJ
ihlr-18810	793	20	the	the	DET
ihlr-18810	793	21	u.s	u.s	PROPN
ihlr-18810	793	22	.	.	PROPN
ihlr-18810	793	23	are	be	AUX
ihlr-18810	793	24	quite	quite	ADV
ihlr-18810	793	25	similar	similar	ADJ
ihlr-18810	793	26	.	.	PUNCT
ihlr-18810	794	1	one	one	NUM
ihlr-18810	794	2	study	study	NOUN
ihlr-18810	794	3	found	find	VERB
ihlr-18810	794	4	that	that	SCONJ
ihlr-18810	794	5	the	the	DET
ihlr-18810	794	6	overall	overall	ADJ
ihlr-18810	794	7	number	number	NOUN
ihlr-18810	794	8	of	of	ADP
ihlr-18810	794	9	annual	annual	ADJ
ihlr-18810	794	10	recalls	recall	NOUN
ihlr-18810	794	11	of	of	ADP
ihlr-18810	794	12	devices	device	NOUN
ihlr-18810	794	13	between	between	ADP
ihlr-18810	794	14	2005	2005	NUM
ihlr-18810	794	15	and	and	CCONJ
ihlr-18810	794	16	2009	2009	NUM
ihlr-18810	794	17	was	be	AUX
ihlr-18810	794	18	very	very	ADV
ihlr-18810	794	19	similar	similar	ADJ
ihlr-18810	794	20	between	between	ADP
ihlr-18810	794	21	the	the	DET
ihlr-18810	794	22	u.s	u.s	PROPN
ihlr-18810	794	23	.	.	PROPN
ihlr-18810	794	24	and	and	CCONJ
ihlr-18810	794	25	europe	europe	PROPN
ihlr-18810	794	26	,	,	PUNCT
ihlr-18810	794	27	hovering	hover	VERB
ihlr-18810	794	28	around	around	ADP
ihlr-18810	794	29	21.311	21.311	NUM
ihlr-18810	794	30	the	the	DET
ihlr-18810	794	31	study	study	NOUN
ihlr-18810	794	32	found	find	VERB
ihlr-18810	794	33	that	that	SCONJ
ihlr-18810	794	34	for	for	ADP
ihlr-18810	794	35	the	the	DET
ihlr-18810	794	36	u.s	u.s	PROPN
ihlr-18810	794	37	.	.	PROPN
ihlr-18810	794	38	,	,	PUNCT
ihlr-18810	794	39	45	45	NUM
ihlr-18810	794	40	%	%	NOUN
ihlr-18810	794	41	of	of	ADP
ihlr-18810	794	42	the	the	DET
ihlr-18810	794	43	recalls	recall	NOUN
ihlr-18810	794	44	related	relate	VERB
ihlr-18810	794	45	to	to	ADP
ihlr-18810	794	46	pre	pre	ADJ
ihlr-18810	794	47	-	-	ADJ
ihlr-18810	794	48	market	market	ADJ
ihlr-18810	794	49	issues	issue	NOUN
ihlr-18810	794	50	while	while	SCONJ
ihlr-18810	794	51	55	55	NUM
ihlr-18810	794	52	%	%	NOUN
ihlr-18810	794	53	related	relate	VERB
ihlr-18810	794	54	to	to	ADP
ihlr-18810	794	55	post	post	ADJ
ihlr-18810	794	56	-	-	ADJ
ihlr-18810	794	57	market	market	ADJ
ihlr-18810	794	58	issues	issue	NOUN
ihlr-18810	794	59	.	.	PUNCT
ihlr-18810	795	1	312	312	NUM
ihlr-18810	795	2	to	to	PART
ihlr-18810	795	3	compare	compare	VERB
ihlr-18810	795	4	,	,	PUNCT
ihlr-18810	795	5	the	the	DET
ihlr-18810	795	6	rates	rate	NOUN
ihlr-18810	795	7	for	for	ADP
ihlr-18810	795	8	europe	europe	PROPN
ihlr-18810	795	9	were	be	AUX
ihlr-18810	795	10	46	46	NUM
ihlr-18810	795	11	%	%	NOUN
ihlr-18810	795	12	and	and	CCONJ
ihlr-18810	795	13	54	54	NUM
ihlr-18810	795	14	%	%	NOUN
ihlr-18810	795	15	,	,	PUNCT
ihlr-18810	795	16	respectively	respectively	ADV
ihlr-18810	795	17	.	.	PUNCT
ihlr-18810	796	1	3	3	NUM
ihlr-18810	796	2	1	1	NUM
ihlr-18810	796	3	3	3	NUM
ihlr-18810	796	4	these	these	DET
ihlr-18810	796	5	findings	finding	NOUN
ihlr-18810	796	6	suggest	suggest	VERB
ihlr-18810	796	7	that	that	SCONJ
ihlr-18810	796	8	the	the	DET
ihlr-18810	796	9	faster	fast	ADJ
ihlr-18810	796	10	approval	approval	NOUN
ihlr-18810	796	11	processes	process	NOUN
ihlr-18810	796	12	used	use	VERB
ihlr-18810	796	13	in	in	ADP
ihlr-18810	796	14	europe	europe	PROPN
ihlr-18810	796	15	does	do	AUX
ihlr-18810	796	16	not	not	PART
ihlr-18810	796	17	sacrifice	sacrifice	VERB
ihlr-18810	796	18	patient	patient	ADJ
ihlr-18810	796	19	safety	safety	NOUN
ihlr-18810	796	20	.	.	PUNCT
ihlr-18810	797	1	iv	iv	X
ihlr-18810	797	2	.	.	PUNCT
ihlr-18810	797	3	conclusion	conclusion	NOUN
ihlr-18810	797	4	it	it	PRON
ihlr-18810	797	5	is	be	AUX
ihlr-18810	797	6	apparent	apparent	ADJ
ihlr-18810	797	7	that	that	SCONJ
ihlr-18810	797	8	the	the	DET
ihlr-18810	797	9	510(k	510(k	PROPN
ihlr-18810	797	10	)	)	PUNCT
ihlr-18810	797	11	clearance	clearance	NOUN
ihlr-18810	797	12	process	process	NOUN
ihlr-18810	797	13	does	do	AUX
ihlr-18810	797	14	not	not	PART
ihlr-18810	797	15	sufficiently	sufficiently	ADV
ihlr-18810	797	16	protect	protect	VERB
ihlr-18810	797	17	patients	patient	NOUN
ihlr-18810	797	18	from	from	ADP
ihlr-18810	797	19	unsafe	unsafe	ADJ
ihlr-18810	797	20	medical	medical	ADJ
ihlr-18810	797	21	devices	device	NOUN
ihlr-18810	797	22	.	.	PUNCT
ihlr-18810	798	1	although	although	SCONJ
ihlr-18810	798	2	creating	create	VERB
ihlr-18810	798	3	a	a	DET
ihlr-18810	798	4	new	new	ADJ
ihlr-18810	798	5	regulatory	regulatory	ADJ
ihlr-18810	798	6	framework	framework	NOUN
ihlr-18810	798	7	involving	involve	VERB
ihlr-18810	798	8	more	more	ADJ
ihlr-18810	798	9	pre	pre	ADJ
ihlr-18810	798	10	-	-	NOUN
ihlr-18810	798	11	market	market	ADJ
ihlr-18810	798	12	and	and	CCONJ
ihlr-18810	798	13	post	post	ADJ
ihlr-18810	798	14	-	-	ADJ
ihlr-18810	798	15	market	market	ADJ
ihlr-18810	798	16	regulation	regulation	NOUN
ihlr-18810	798	17	and	and	CCONJ
ihlr-18810	798	18	relying	rely	VERB
ihlr-18810	798	19	on	on	ADP
ihlr-18810	798	20	scientific	scientific	ADJ
ihlr-18810	798	21	evidence	evidence	NOUN
ihlr-18810	798	22	in	in	ADP
ihlr-18810	798	23	reaching	reach	VERB
ihlr-18810	798	24	determinations	determination	NOUN
ihlr-18810	798	25	of	of	ADP
ihlr-18810	798	26	safety	safety	NOUN
ihlr-18810	798	27	and	and	CCONJ
ihlr-18810	798	28	effectiveness	effectiveness	NOUN
ihlr-18810	798	29	is	be	AUX
ihlr-18810	798	30	one	one	NUM
ihlr-18810	798	31	possible	possible	ADJ
ihlr-18810	798	32	way	way	NOUN
ihlr-18810	798	33	to	to	PART
ihlr-18810	798	34	improve	improve	VERB
ihlr-18810	798	35	device	device	NOUN
ihlr-18810	798	36	regulation	regulation	NOUN
ihlr-18810	798	37	,	,	PUNCT
ihlr-18810	798	38	the	the	DET
ihlr-18810	798	39	feasibility	feasibility	NOUN
ihlr-18810	798	40	of	of	ADP
ihlr-18810	798	41	this	this	DET
ihlr-18810	798	42	method	method	NOUN
ihlr-18810	798	43	is	be	AUX
ihlr-18810	798	44	limited	limit	VERB
ihlr-18810	798	45	due	due	ADP
ihlr-18810	798	46	to	to	ADP
ihlr-18810	798	47	the	the	DET
ihlr-18810	798	48	inability	inability	NOUN
ihlr-18810	798	49	of	of	ADP
ihlr-18810	798	50	the	the	DET
ihlr-18810	798	51	fda	fda	PROPN
ihlr-18810	798	52	's	's	PART
ihlr-18810	798	53	current	current	ADJ
ihlr-18810	798	54	resource	resource	NOUN
ihlr-18810	798	55	constraints	constraint	NOUN
ihlr-18810	798	56	.	.	PUNCT
ihlr-18810	799	1	instead	instead	ADV
ihlr-18810	799	2	,	,	PUNCT
ihlr-18810	799	3	the	the	DET
ihlr-18810	799	4	best	good	ADJ
ihlr-18810	799	5	way	way	NOUN
ihlr-18810	799	6	to	to	PART
ihlr-18810	799	7	ensure	ensure	VERB
ihlr-18810	799	8	the	the	DET
ihlr-18810	799	9	safety	safety	NOUN
ihlr-18810	799	10	and	and	CCONJ
ihlr-18810	799	11	efficacy	efficacy	NOUN
ihlr-18810	799	12	of	of	ADP
ihlr-18810	799	13	medical	medical	ADJ
ihlr-18810	799	14	devices	device	NOUN
ihlr-18810	799	15	is	be	AUX
ihlr-18810	799	16	for	for	ADP
ihlr-18810	799	17	the	the	DET
ihlr-18810	799	18	federal	federal	ADJ
ihlr-18810	799	19	government	government	NOUN
ihlr-18810	799	20	,	,	PUNCT
ihlr-18810	799	21	in	in	ADP
ihlr-18810	799	22	its	its	PRON
ihlr-18810	799	23	capacity	capacity	NOUN
ihlr-18810	799	24	as	as	ADP
ihlr-18810	799	25	payer	payer	NOUN
ihlr-18810	799	26	,	,	PUNCT
ihlr-18810	799	27	to	to	PART
ihlr-18810	799	28	use	use	VERB
ihlr-18810	799	29	cer	cer	PROPN
ihlr-18810	799	30	of	of	ADP
ihlr-18810	799	31	medical	medical	ADJ
ihlr-18810	799	32	devices	device	NOUN
ihlr-18810	799	33	entering	enter	VERB
ihlr-18810	799	34	the	the	DET
ihlr-18810	799	35	market	market	NOUN
ihlr-18810	799	36	.	.	PUNCT
ihlr-18810	800	1	this	this	DET
ihlr-18810	800	2	information	information	NOUN
ihlr-18810	800	3	would	would	AUX
ihlr-18810	800	4	be	be	AUX
ihlr-18810	800	5	used	use	VERB
ihlr-18810	800	6	by	by	ADP
ihlr-18810	800	7	these	these	DET
ihlr-18810	800	8	federal	federal	ADJ
ihlr-18810	800	9	programs	program	NOUN
ihlr-18810	800	10	in	in	ADP
ihlr-18810	800	11	determining	determine	VERB
ihlr-18810	800	12	whether	whether	SCONJ
ihlr-18810	800	13	or	or	CCONJ
ihlr-18810	800	14	not	not	PART
ihlr-18810	800	15	devices	device	NOUN
ihlr-18810	800	16	will	will	AUX
ihlr-18810	800	17	be	be	AUX
ihlr-18810	800	18	covered	cover	VERB
ihlr-18810	800	19	,	,	PUNCT
ihlr-18810	800	20	and	and	CCONJ
ihlr-18810	800	21	will	will	AUX
ihlr-18810	800	22	alleviate	alleviate	VERB
ihlr-18810	800	23	the	the	DET
ihlr-18810	800	24	burdens	burden	NOUN
ihlr-18810	800	25	on	on	ADP
ihlr-18810	800	26	the	the	DET
ihlr-18810	800	27	fda	fda	PROPN
ihlr-18810	800	28	by	by	ADP
ihlr-18810	800	29	shifting	shift	VERB
ihlr-18810	800	30	the	the	DET
ihlr-18810	800	31	responsibility	responsibility	NOUN
ihlr-18810	800	32	for	for	ADP
ihlr-18810	800	33	this	this	DET
ihlr-18810	800	34	increase	increase	NOUN
ihlr-18810	800	35	post	post	ADJ
ihlr-18810	800	36	-	-	ADJ
ihlr-18810	800	37	market	market	ADJ
ihlr-18810	800	38	309	309	NUM
ihlr-18810	800	39	pollack	pollack	NOUN
ihlr-18810	800	40	,	,	PUNCT
ihlr-18810	800	41	supra	supra	PROPN
ihlr-18810	800	42	note	note	NOUN
ihlr-18810	800	43	219	219	NUM
ihlr-18810	800	44	.	.	PUNCT
ihlr-18810	801	1	other	other	ADJ
ihlr-18810	801	2	examples	example	NOUN
ihlr-18810	801	3	of	of	ADP
ihlr-18810	801	4	devices	device	NOUN
ihlr-18810	801	5	approved	approve	VERB
ihlr-18810	801	6	in	in	ADP
ihlr-18810	801	7	europe	europe	PROPN
ihlr-18810	801	8	but	but	CCONJ
ihlr-18810	801	9	not	not	PART
ihlr-18810	801	10	available	available	ADJ
ihlr-18810	801	11	in	in	ADP
ihlr-18810	801	12	the	the	DET
ihlr-18810	801	13	united	united	PROPN
ihlr-18810	801	14	states	states	PROPN
ihlr-18810	801	15	include	include	VERB
ihlr-18810	801	16	artificial	artificial	ADJ
ihlr-18810	801	17	disks	disk	NOUN
ihlr-18810	801	18	for	for	ADP
ihlr-18810	801	19	spines	spine	NOUN
ihlr-18810	801	20	.	.	PUNCT
ihlr-18810	802	1	310	310	NUM
ihlr-18810	802	2	i	i	PRON
ihlr-18810	802	3	d.	d.	PROPN
ihlr-18810	802	4	311	311	NUM
ihlr-18810	802	5	davis	davis	PROPN
ihlr-18810	802	6	,	,	PUNCT
ihlr-18810	802	7	supra	supra	PROPN
ihlr-18810	802	8	note	note	PROPN
ihlr-18810	802	9	221	221	NUM
ihlr-18810	802	10	,	,	PUNCT
ihlr-18810	802	11	at	at	ADP
ihlr-18810	802	12	9	9	NUM
ihlr-18810	802	13	.	.	X
ihlr-18810	803	1	312	312	NUM
ihlr-18810	803	2	i	i	PROPN
ihlr-18810	803	3	d.	d.	NOUN
ihlr-18810	803	4	at	at	ADP
ihlr-18810	803	5	7	7	NUM
ihlr-18810	803	6	.	.	X
ihlr-18810	803	7	313	313	NUM
ihlr-18810	804	1	i	i	NOUN
ihlr-18810	804	2	d.	d.	PROPN
ihlr-18810	804	3	172	172	NUM
ihlr-18810	804	4	vol	vol	NOUN
ihlr-18810	804	5	.	.	PUNCT
ihlr-18810	805	1	10:1	10:1	NUM
ihlr-18810	805	2	2013	2013	NUM
ihlr-18810	805	3	510(k	510(k	PROPN
ihlr-18810	805	4	)	)	PUNCT
ihlr-18810	805	5	clearance	clearance	NOUN
ihlr-18810	805	6	173	173	NUM
ihlr-18810	805	7	study	study	NOUN
ihlr-18810	805	8	and	and	CCONJ
ihlr-18810	805	9	surveillance	surveillance	NOUN
ihlr-18810	805	10	of	of	ADP
ihlr-18810	805	11	510(k	510(k	PROPN
ihlr-18810	805	12	)	)	PUNCT
ihlr-18810	805	13	devices	device	NOUN
ihlr-18810	805	14	from	from	ADP
ihlr-18810	805	15	the	the	DET
ihlr-18810	805	16	fda	fda	PROPN
ihlr-18810	805	17	to	to	ADP
ihlr-18810	805	18	other	other	ADJ
ihlr-18810	805	19	federal	federal	ADJ
ihlr-18810	805	20	agencies	agency	NOUN
ihlr-18810	805	21	.	.	PUNCT
ihlr-18810	806	1	in	in	ADP
ihlr-18810	806	2	this	this	DET
ihlr-18810	806	3	way	way	NOUN
ihlr-18810	806	4	,	,	PUNCT
ihlr-18810	806	5	the	the	DET
ihlr-18810	806	6	u.s	u.s	PROPN
ihlr-18810	806	7	.	.	PROPN
ihlr-18810	806	8	will	will	AUX
ihlr-18810	806	9	foster	foster	VERB
ihlr-18810	806	10	innovation	innovation	NOUN
ihlr-18810	806	11	and	and	CCONJ
ihlr-18810	806	12	maintain	maintain	VERB
ihlr-18810	806	13	a	a	DET
ihlr-18810	806	14	competitive	competitive	ADJ
ihlr-18810	806	15	market	market	NOUN
ihlr-18810	806	16	in	in	ADP
ihlr-18810	806	17	the	the	DET
ihlr-18810	806	18	medical	medical	ADJ
ihlr-18810	806	19	device	device	NOUN
ihlr-18810	806	20	industry	industry	NOUN
ihlr-18810	806	21	,	,	PUNCT
ihlr-18810	806	22	without	without	ADP
ihlr-18810	806	23	sacrificing	sacrifice	VERB
ihlr-18810	806	24	patient	patient	ADJ
ihlr-18810	806	25	safety	safety	NOUN
ihlr-18810	806	26	through	through	ADP
ihlr-18810	806	27	this	this	DET
ihlr-18810	806	28	more	more	ADV
ihlr-18810	806	29	efficient	efficient	ADJ
ihlr-18810	806	30	approval	approval	NOUN
ihlr-18810	806	31	process	process	NOUN
ihlr-18810	806	32	.	.	PUNCT
ihlr-18810	807	1	healthcare	healthcare	NOUN
ihlr-18810	807	2	providers	provider	NOUN
ihlr-18810	807	3	will	will	AUX
ihlr-18810	807	4	likewise	likewise	ADV
ihlr-18810	807	5	benefit	benefit	VERB
ihlr-18810	807	6	from	from	ADP
ihlr-18810	807	7	this	this	DET
ihlr-18810	807	8	proposal	proposal	NOUN
ihlr-18810	807	9	,	,	PUNCT
ihlr-18810	807	10	as	as	SCONJ
ihlr-18810	807	11	additional	additional	ADJ
ihlr-18810	807	12	research	research	NOUN
ihlr-18810	807	13	is	be	AUX
ihlr-18810	807	14	still	still	ADV
ihlr-18810	807	15	conducted	conduct	VERB
ihlr-18810	807	16	regarding	regard	VERB
ihlr-18810	807	17	the	the	DET
ihlr-18810	807	18	comparative	comparative	ADJ
ihlr-18810	807	19	effectiveness	effectiveness	NOUN
ihlr-18810	807	20	of	of	ADP
ihlr-18810	807	21	new	new	ADJ
ihlr-18810	807	22	devices	device	NOUN
ihlr-18810	807	23	,	,	PUNCT
ihlr-18810	807	24	and	and	CCONJ
ihlr-18810	807	25	this	this	DET
ihlr-18810	807	26	information	information	NOUN
ihlr-18810	807	27	will	will	AUX
ihlr-18810	807	28	be	be	AUX
ihlr-18810	807	29	available	available	ADJ
ihlr-18810	807	30	to	to	PART
ihlr-18810	807	31	guide	guide	VERB
ihlr-18810	807	32	medical	medical	ADJ
ihlr-18810	807	33	decision	decision	NOUN
ihlr-18810	807	34	making	make	VERB
ihlr-18810	807	35	and	and	CCONJ
ihlr-18810	807	36	ensure	ensure	VERB
ihlr-18810	807	37	patients	patient	NOUN
ihlr-18810	807	38	receive	receive	VERB
ihlr-18810	807	39	the	the	DET
ihlr-18810	807	40	safest	safe	ADJ
ihlr-18810	807	41	and	and	CCONJ
ihlr-18810	807	42	most	most	ADV
ihlr-18810	807	43	effective	effective	ADJ
ihlr-18810	807	44	treatments	treatment	NOUN
ihlr-18810	807	45	available	available	ADJ
ihlr-18810	807	46	.	.	PUNCT