15/16 December 2020
In autumn 2015, the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) published a "Draft Guidance for Industry and FDA Staff on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products". This document provides support for human cells, tissues, and cellular and tissue-based product (HCT/P) establishments, health care providers, and FDA staff for applying Title 21 of the Code of Federal Regulations (CFR) Part 1271. It specifically covers 21 CFR 1271.10(a)(2) criterion of homologous use.
Amongst some background information, the guidance document includes a chapter with questions and answers - covering issue from "What is the definition of homologous use? to "Does my HCT/P have to be used in the same anatomic location to perform the same basic function or functions?"
HCT/Ps are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. The FDA has implemented a risk-based approach to the regulation of HCT/Ps. Under the authority of section 361 of the PHS Act, the authority established regulations for all HCT/Ps to prevent the introduction, transmission, and spread of communicable diseases. These regulations can be found in 21 CFR Part 1271.
To get more information about the interpretation and application of the homologous use criterion and related definitions look at the complete draft "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products".