FDA’s Regulatory Scheme for Human Tissue

In recent years, industry has accelerated the development of novel cellular and tissue-based products that provide increasingly useful therapies for a wide range of medical conditions. The Food and Drug Administration (FDA) calls these products “human cells, tissues, and cellular or tissue-based products” (HCT/Ps). This article explains the jurisdictional criteria for regulation of a product as an HCT/P solely under Part 1271. The article also describes the process for requesting an informal jurisdictional determination on this question from the Tissue Reference Group (TRG), as well as the Request for Designation (RFD) process for requesting a formal determination from the Office of Combination Products (OCP).