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# Guidance on Adverse Reactions Related to HCT/P Products
- URL: https://www.fdaweb.com/guidance-on-adverse-reactions-related-to-hct-p-products/
- Published: 2016-03-09T12:00:00.000Z
- Updated: 2026-09-15T02:42:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135023

*Federal Register* Notice: FDA is making available a guidance document: *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*. It provides establishments that manufacture HCT/Ps for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The guidance also provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A. The guidance supplements section XXII of FDA’s guidance entitled Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated 12/2011 and supersedes the guidance entitled Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated 11/2005\. The guidance finalizes the draft guidance of the same title dated 2/2015\. To download this guidance, click [here.](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM434834.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-09/pdf/2016-05215.pdf?ref=fdaweb.com)