Opportunity
Federal Register #2026-22369
FDA final guidance on reducing hepatitis B transmission risk in blood and plasma donations
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
November 03, 2026
Identifier
2026-22369
The FDA issued final guidance on reducing the risk of hepatitis B virus transmission through blood and plasma donations. - Government buyer/issuer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); the guidance is directed to blood establishments collecting Whole Blood and blood components, including Source Plasma. - Guidance topics: HBV donation testing, donor deferral and requalification, and blood product management, retrieval, and quarantine. - Notable recommendations: For certain donations, hepatitis B surface antigen (HBsAg) testing may not be necessary when licensed, approved, or cleared HBV nucleic acid and anti-HBc tests are used. For Source Plasma donations, the guidance recommends HBsAg and HBV nucleic acid testing. - Prior guidance: Finalizes earlier draft recommendations and supersedes several previous FDA documents concerning HBV testing and donor management. - Procurement scope: No products or services are being requested; no OEMs, vendors, quantities, or part numbers are identified.
Description
The FDA announced the availability of final guidance with recommendations for blood establishments that collect Whole Blood and blood components, including Source Plasma, to reduce the risk of transfusion-transmitted hepatitis B virus. The guidance addresses donation testing, donor deferral and requalification, and product management, retrieval, and quarantine. It finalizes the July 2025 draft guidance and supersedes several prior FDA documents and recommendations concerning hepatitis B testing and donor management.