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).
This guidance document does not apply to reproductive HCT/Ps or to HCT/Ps regulated under 21 CFR Part 1270 and recovered before May 25, 2005. Furthermore, this guidance does not apply to healthcare professionals who implant, transplant, infuse, or transfer HCT/Ps into recipients.
This guidance document also does not apply to HCT/Ps that are regulated as drugs, devices, and/or biological products under section 351 of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, nor does it apply to investigational HCT/Ps subject to an investigational new drug (IND) application or an investigational device exemption (IDE). This guidance finalizes the draft guidance of the same title dated December 2015.