Hutt, Peter BartonLeon, Doraliz2012-07-062003FDA Premarket Regulation of Tissue-Engineered Replacement Parts for Humans (2003 Third Year Paper)http://nrs.harvard.edu/urn-3:HUL.InstRepos:8965598This paper is a description of tissue-engineered products, their potential for replacing conventional approaches to missing or failing tissues and organs, and FDA’s ongoing efforts to develop a comprehensive and uniform scheme for regulating them.en-USFood and Drug Lawprostheticsprosthesisartificial organsreplacement partsFDA Premarket Regulation of Tissue-Engineered Replacement Parts for HumansPaper (for course/seminar/workshop)2012-07-06