USA – Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

We, FDA, are providing you, human cells, tissues, and cellular and tissue-based product
(HCT/P) manufacturers, healthcare providers, and FDA staff, with our current thinking on the criteria under Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the 21 CFR 1271.10(a)(1) criterion of minimal manipulation and the 21 CFR 1271.10(a)(2) criterion of homologous use.

This guidance supersedes the guidance of the same title dated November 2017 and corrected December 2017. This guidance revises section V. to extend the period of enforcement discretion through May 31, 2021.

The interpretation of the minimal manipulation and homologous use criteria and definitions of related key terms have been of considerable interest to industry stakeholders since the criteria and definitions were first proposed. This guidance is intended to improve stakeholders’ understanding of the definitions of minimal manipulation in 21 CFR 1271.3(f) and homologous use in 21 CFR 1271.3(c). It will also facilitate stakeholders’ understanding of how the regulatory criteria in 21 CFR 1271.10(a)(1) and (2) apply to their HCT/Ps.2F In addition, the November 2017 version of the guidance informed manufacturers, healthcare providers, and other interested persons that over the next 36 months (through November 2020), we intended to exercise enforcement discretion under limited conditions with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps. The current version of this guidance explains that FDA intends to exercise such enforcement discretion for a longer period of time: through May 2021…