id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ihlr-16461	Williams, Jason L.	Patient Safety or Profit: What Incentives are Blood Shield Laws and FDA Regulations Creating for the Tissue Banking Industry?	2005	34	.pdf	application/pdf	16369	1053	58	Tissue based products offer a unique challenge to strict liability because they are inherently dangerous; however, tissue products can be designed in a way that significantly reduces the inherent riSks. Tissue products are exempt from the more stringent requirements on drugs and medical devices if they meet the following criteria: (1) the product is minimally manipulated; (2) the product is intended for a homologous use;39 (3) the processor does not combine another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, with the tissue; and (4) the product does not have a systemic effect and is not dependent upon 28.	cache/ihlr-16461.pdf	txt/ihlr-16461.txt