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FDA Premarket Regulation of Tissue-Engineered Replacement Parts for Humans

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2003

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FDA Premarket Regulation of Tissue-Engineered Replacement Parts for Humans (2003 Third Year Paper)

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Abstract

This 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.

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Food and Drug Law, prosthetics, prosthesis, artificial organs, replacement parts

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