# 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: Guidance for Industry - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigating-and-reporting-adverse-reactions-related-to-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-regulated-solely-under-section-361-of-the-public-health-service-act-and-21-cfr-part-1271-guidance-for-industry/4d5c1dc2-b92f-4125-883d-f9883e7a1a2d > FDA 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: Guidance for Industry. Issue date: March 08, 2016. Get complete insights and analysis. --- ## Details - Title: 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: Guidance for Industry - Communication Type: Guidance Document - Product Type: biologics - Office Name: Center for Biologics Evaluation and Research - Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d - Issue Date: 2016-03-08 - Last Changed: 2025-02-03 - Docket Number: FDA-2015-D-0309 ## Related Documents - [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](https://www.globalkeysolutions.net/guidances/guidance-document/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/8e4fe25d-123f-4637-babd-6b10a4a39471) - [Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-nucleic-acid-tests-to-reduce-the-risk-of-transmission-of-hepatitis-b-virus-from-donors-of-human-cells-tissues-and-cellular-and-tissue-based-products-guidance-for-industry/ff060472-0a8c-471b-b947-33ce77342401) - [Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis): Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-donor-screening-tests-to-test-donors-of-human-cells-tissues-and-cellular-and-tissue-based-products-for-infection-with-treponema-pallidum-syphilis-guidance-for-industry/9fd76c90-747b-4a80-812b-09cfac7a01e4)