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GUIDANCE DOCUMENT

Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen Draft Guidance for Industry July 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-5942
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document provides you, blood establishments that collect blood and blood components, including Source Plasma, with FDA’s recommendations for testing blood and blood components for hepatitis B surface antigen (HBsAg) to reduce the risk of transfusion-transmitted hepatitis B virus (HBV).  The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, including Source Plasma.  

Under 21 CFR 610.40(a), an establishment that collects blood and blood components must test each donation of human blood or blood components for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device, for evidence of infection due to certain relevant transfusion-transmitted infections (RTTIs), including HBV.  In addition, under 21 CFR 610.40(b), establishments must perform one or more screening tests that FDA has licensed, approved or cleared as necessary to reduce adequately and appropriately the risk of transmission of RTTIs.

This guidance, when finalized, will supersede the recommendation to test all blood donations for HBsAg in the guidance document entitled:  “Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus,” dated October 2012 (Ref. 1).

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Submit Comments Online

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-2024-D-5942.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010
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