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GUIDANCE DOCUMENT

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of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry January 2025

Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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-0465
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 B virus (HBV) by HCT/Ps.  This guidance updates information regarding HBV 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 HBV risk using the same individual risk-based questions regardless of sex or gender.  Additionally, this guidance incorporates information from the guidance entitled “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” dated August 2016 (August 2016 HBV NAT Guidance) and supersedes that guidance.

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0465.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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