03/01/2024

The Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regulates human cells, tissues, and cellular and tissue-based products, or HCT/Ps. These include tissues derived from organs. 

FDA’s regulation of HCT/Ps provides a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice requirements and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps.  

The agency has recently received questions from health professionals about the regulatory status of the fresh allograft heart valves used in a procedure generally referred to as “partial heart transplantation.” This surgical procedure involves transplantation of fresh aortic and/or pulmonary allografts prepared from a donor’s heart for treatment of irreparable congenital heart defects in neonates and infants. 

FDA understands that prior to a partial heart transplantation procedure, the entire donor heart is recovered then packaged to maintain a cold environment and shipped to the transplant center. Once received in the recipient operating room, the aortic and/or pulmonary valves with contiguous tissues are prepared and immediately implanted according to standard surgical technique, for example, for a double root replacement. Provided the fresh allograft heart valves used in these procedures meet all the criteria in FDA’s tissue regulations (21 CFR 1271.10(a)), they are regulated by the agency as HCT/Ps under section 361 of the Public Health Service Act and the regulations in part 1271. Any establishment engaged in the manufacture of HCT/Ps, including but not limited to any or all steps in the recovery, processing, storage, packaging or distribution as well as the screening and testing of the tissue donor are subject to all applicable regulations in 21 CFR part 1271.

Health professionals with questions may contact FDA at ocod@fda.hhs.gov.  HCT/P establishments with questions may contact FDA at industry.biologics@fda.hhs.gov.