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# ‘Fresh Allograft Heart Valves’ Regulated by FDA
- URL: https://www.fdaweb.com/fresh-allograft-heart-valves-regulated-by-fda/
- Published: 2024-03-04T12:00:00.000Z
- Updated: 2026-09-14T14:24:23.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156473

FDA is affirming its regulation of “fresh allograft heart valves” in a [just-posted letter](https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/information-health-professionals-partial-heart-transplantation?ref=fdaweb.com) to healthcare professionals. The letter addresses recent questions the agency has received about the regulatory status of the allograft heart valves used in a procedure commonly referred to as “partial heart transplantation,” which involves transplantation of fresh aortic and pulmonary allografts prepared from a donor’s heart for treating irreparable congenital heart defects in neonates and infants, according to FDA.

Based on the agency’s understanding of the process, “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,” the letter says. “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 \[[human cells, tissues, and cellular and tissue-based products](https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products?ref=fdaweb.com)\] under section 361 of the Public Health Service Act and the regulations in part 1271.”