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GUIDANCE DOCUMENT

Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-0466
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA or Agency, are issuing this guidance to assist you, establishments making donor eligibility determinations,  in understanding the requirements in Title 21 Code of Federal Regulations, part 1271, subpart C (21 CFR part 1271, subpart C).  The regulations under 21 CFR part 1271, subpart C set out requirements for determining donor eligibility, including donor screening and testing, for donors of human cells, tissues, or cellular or tissue-based products (HCT/Ps).  

This guidance applies to human cells and tissues recovered on or after May 25, 2005, the effective date of the regulations contained in 21 CFR part 1271, subpart C, and provides recommendations to reduce the risk of transmission of hepatitis C virus (HCV) by HCT/Ps.  This guidance updates information regarding HCV risk included in the guidance entitled “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry,” dated August 2007 (August 2007 HCT/P DE Guidance), by revising recommendations for:  1) donor screening that includes reducing certain time-based risk factors and conditions, and 2) assessing every HCT/P donor for HCV risk using the same individual risk-based questions for every donor regardless of sex or gender.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2022-D-0466.

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