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# Human Tissue Adverse Reaction Reporting Guidance
- URL: https://www.fdaweb.com/human-tissue-adverse-reaction-reporting-guidance/
- Published: 2016-03-08T12:00:00.000Z
- Updated: 2026-09-15T02:41:49.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5134995

> FDA has issued a guidance, *Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271*, to give establishments that manufacture human cells, tissues, and cellular and tissue-based products with recommendations for complying with requirements for investigating and reporting adverse reactions involving communicable disease in recipients of HCT/Ps regulated solely under Section 361 of the Public Health Service Act (known as 361 HCT/Ps). The [guidance](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM434834.pdf?ref=fdaweb.com) does not apply to reproductive HCT/Ps or to tissues covered under other regulations. It also does not apply to health professionals who implant, transplant, infuse, or transfer HCT/Ps into recipients.  
>  
> The question-and-answer guidance covers regulatory requirements regarding investigating and reporting adverse reactions, adverse reaction investigation, adverse reaction reporting, and implementation.