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# Guidance on Tissue/Cell Therapy Deviation Reporting
- URL: https://www.fdaweb.com/guidance-on-tissue-cell-therapy-deviation-reporting/
- Published: 2017-09-07T12:00:00.000Z
- Updated: 2026-09-14T22:47:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139568

*Federal Register* notice: FDA has made available a guidance on “Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271.” The document provides establishments that manufacture such products with recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-07/pdf/2017-18737.pdf?ref=fdaweb.com).