FDA Publishes Final Guidance for Reporting HCT/P Deviations

Posted in :: 2017 Volume 2 :: Thursday, October 26th, 2017

The Food and Drug Administration (FDA) announced the availability of a final 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 certain 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 report HCT/P deviations.