Docket Number:
FDA-2017-D-6146
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

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.

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All written comments should be identified with this document's docket number: FDA-2017-D-6146.

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