Bulletin 17-8

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FDA Finalizes Guidance on HCT/P Deviation Reporting

Bulletin 17-8

September 7, 2017

The U.S. Food and Drug Administration (FDA) released a finalized guidance on Wednesday to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency's recommendations for complying with the requirements to investigate and report HCT/P deviations.

The guidance, titled 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Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry, is the final version of a draft guidance from December 2015. The final guidance provides additional examples and editorial changes to illustrate the most frequently reported deviations to the Center for Biologics Evaluation and Research (CBER).

Under 21 CFR 1271.350(b)(1), an establishment must investigate all HCT/P deviations related to a distributed HCT/P for which they performed a manufacturing step, including any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue and the screening or testing of the cell or tissue donor (21 CFR 1271.3(e)), and must report the deviation to FDA within 45 days of the discovery of the event.

If the HCT/P deviation occurred in a facility that performed a manufacturing step for you under contract, agreement, or other arrangement, the time period for reporting will start when the contract establishment first learned about the event. FDA recommends that the establishment that distributed the HCT/P submit the report required under 21 CFR 1271.350(b)(2).