The FDA has released a draft document entitled “Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The draft document provides establishments that manufacture HCT/Ps with recommendations for complying with CGTP requirements. This guidance also addresses whether the establishment registration and HCT/P listing requirements under 21 CFR part 1271, subparts A and B apply in certain instances. The FDA will accept comments on the guidance through April 16, 2009.
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