Definition | Any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a non-human animal source, or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live, non-human animal cells, tissues, or organs. Xenotransplantation products include live cells, tissues and organs.
Biological products, drugs, or medical devices sourced from nonliving cells, tissues or organs from non-human animals, including but not limited to porcine insulin, porcine heart valves, and collagen matrices derived from acellular porcine, bovine or any other xenogeneic source (e.g. PelviSoft®, Bio-Oss®, Bio-Gide® and Surgibone®) are not considered xenotransplantation products. |