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

Issue Date: September 6, 2017
Issued by: Center for Biologics Evaluation and Research
Topic(s): Cellular & Gene Therapy, Tissue
Status: Final

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

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).

Download the Guidance Document