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FDA presentation on Regulation of Allograft Heart Valves addresses the role of the OPTN and the FDA in partial heart transplant procedures

Published on: Wednesday, April 17, 2024

The U.S. Food and Drug Administration (FDA) presented on “Regulation of Allograft Heart Valves” to the Organ Procurement and Transplantation Network (OPTN) Operations and Safety Committee on July 27, 2023. The presentation was provided by Dr. Scott Brubaker, Director of Human Tissues/Office of Cellular Therapy and Human Tissue/Center for Biologics Evaluation and Research/FDA.

This presentation addressed questions from the transplant community about whether or not “partial heart transplant” procedures, recently publicized in the media, fall within the oversight authority of the OPTN (as a solid organ transplant) or the FDA (as a type of tissue transplant).

This presentation also clarified the role of the FDA and, specifically, its regulatory oversight authority of the surgical transplant procedure of fresh heart valves from deceased human donors.

Access the presentation