Articles
Regulatory Considerations for HCT/Ps
Jul 01, 2020
Minimal Manipulation
GUIDANCE FOR FOOD AND DRUG ADMINISTRATIVE STAFF
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.