The Food and Drug Administration (FDA) is issuing this guidance to provide sponsors and applicants of xenotransplantation products with updates concerning the production, testing, and evaluation of products, during protocol development and during the preparation of submissions to FDA, e.g., Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs). This guidance also includes updated references and Agency practices intended to prevent the introduction and spread of infectious agents of animal origin into the human population. This guidance amends the guidance of the same title dated April 2003 (April 2003 guidance).
For the purpose of this document, xenotransplantation refers to 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. Also, for the purpose of this document, xenotransplantation products include live cells, tissues, or organs used in xenotransplantation. However, for the purpose of this guidance, xenotransplantation does not include transplantation, implantation, or other use of acellular animal tissues. These acellular products derived from animal tissue, often referred to as xenografts, are beyond the scope of this guidance.