Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 Guidance for Industry September 2017
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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
We, the Food and Drug Administration (FDA), are issuing this guidance to provide you, establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations under Title 21 of the Code of Federal Regulations (CFR) Part 1271, with recommendations and relevant examples for complying with the requirements under 21 CFR 1271.350(b) to investigate and report HCT/P deviations. The examples provided in this guidance have been chosen to illustrate those HCT/P deviations that have been most frequently reported to FDA’s Center for Biologics Evaluation and Research (CBER).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2015-D-4386.