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# HCT/P Deviation Reporting Guidance Out
- URL: https://www.fdaweb.com/hct-p-deviation-reporting-guidance-out/
- Published: 2017-09-06T12:00:00.000Z
- Updated: 2026-09-14T22:47:07.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5139559

FDA has published a guidance, *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*, with recommendations and relevant examples for establishments that manufacture certain non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/P) to investigate and report HCT/P deviations. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM574767.pdf?ref=fdaweb.com) says the examples it contains were chosen to illustrate those HCT/P deviations that have been most frequently reported to CBER.

The guidance does not apply to reproductive HCT/Ps nor to HCT/Ps regulated under 21 CFR Part 1270 and recovered before 5/25/05\. It also does not apply to healthcare professionals who implant, transplant, infuse, or transfer HCT/Ps into recipients. And it does not apply to HCT/Ps that are regulated as drugs, medical devices, and/or biological products under Section 351 of the Public Health Service Act and/or the Federal Food, Drug, and Cosmetic Act, nor does it apply to investigational HCT/Ps subject to an IND or IDE.

The guidance finalizes a 12/2015 draft.