FDA has regulatory oversight of xenotransplantation products, including live organs, tissues, or cells from a nonhuman animal source or xenotransplantation product materials used in encapsulated form or in which nonhuman live organs, tissues, or cells have ex vivo contact with human body fluids, cells, tissues, or organs that are subsequently given to a human recipient. If xenotransplantation products are to be used in clinical investigation, they require an appropriate investigational application be in place. FDA will regulate most xenotransplantation products as biological products. CBER regulates biological products, including cellular therapies, under authority of section 351 of the PHS Act (42 U.S.C. 262) and the Act (21 U.S.C. 321 et seq.). Some products may be combination products consisting of a biologic and a device, such as xenogeneic cells contained in a device used for extracorporeal hemoperfusion.
Xenotransplantation is any procedure that involves the transplantation, implantation or infusion into a human recipient of either
1. live cells, tissues, or organs from a nonhuman animal source, or
2. human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs.
The development of xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation far exceeds the supply.
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