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The Center for Biologics Evaluation and Research (CBER) currently regulates under 21 CFR Part 1270 human tissue intended for transplantation that is recovered, processed, stored, or distributed by methods that do not change tissue function or characteristics and that is not currently regulated as a human drug, biological product, or medical device. Examples of such tissues are bone, skin, corneas, ligament and tendon. Part 1270 requires 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.
FDA is in the process of revising the regulation of human tissues, cells, and cellular and tissue-based products. The proposed regulatory approach would address a broader scope of products, include more comprehensive requirements to prevent the transmission of communicable disease, and would apply tiered requirements based on the characteristics of such products.
CBER does not regulate vascularized human organ transplants such as kidney, liver, heart, lung or pancreas. The federal Health Resources Services Administration (HRSA) provides oversight and funding support for the nation's organ procurement allocation and transplantation system, coordinates national organ and tissue donation activities, funds research to learn more about what works to increase donation, and administers the national bone marrow registry program.
CBER also regulates xenotransplantation, which is any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (A.) live cells, tissues, or organs from a nonhuman animal source or (B.) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs. Xenotransplantation using cells and tissues has been used experimentally to treat certain diseases such as neurodegenerative disorders, liver failure, and diabetes, where human materials are not usually available.
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