Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``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.'' The guidance document provides establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015.