Ifactor biologics1/8/2024 ![]() ![]() FDA's revised regulations are contained in Part 1271 and apply to tissues recovered after May 25, 2005. The third final rule establishes current good tissue practices for HCT/Ps. The second rule requires tissue establishments to evaluate donors, through screening and testing, to reduce the transmission of infectious diseases through tissue transplantation. One final rule requires firms to register and list their HCT/Ps with FDA. FDA has published three final rules to broaden the scope of products subject to regulation and to include more comprehensive requirements to prevent the introduction, transmission and spread of communicable disease. Parts 12 require tissue establishments to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs. CBER does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 12. Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P.
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