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# Guidance on HCT/P Deviation Reporting
- URL: https://www.fdaweb.com/guidance-on-hct-p-deviation-reporting/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134331

*Federal Register* Notice: FDA is making available a draft 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and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry*. It 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 nd under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations. To download this guidance, click [here](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM478826.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2015-12-24/pdf/2015-32323.pdf?ref=fdaweb.com).