Issue Date: November 3, 2026
Issued by: Center for Biologics Evaluation and Research
Topic(s): Hepatitis B, Blood Products, Testing
Status: Final
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Guidance for Industry
We, FDA, are providing you, blood establishments that collect blood and blood components, including Source Plasma, with recommendations for testing blood and blood components for hepatitis B virus (HBV) to reduce the risk of transfusion-transmitted HBV. The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, including Source Plasma. HBV is a relevant transfusion-transmitted infection (RTTI) (Title 21 of the Code of Federal Regulations (CFR) 630.3(h)(1)(ii)) and, therefore, subject to the testing requirements in 21 CFR 610.40, the donor deferral requirements in 21 CFR 610.41 and the donor notification requirements in 21 CFR 630.40. Under 21 CFR 610.40(a)(1), 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 HBV. In addition, under 21 CFR 610.40(b), establishments must use, in accordance with the manufacturer’s instructions, one or more screening tests that FDA has licensed, approved or cleared as necessary to meet the testing requirement and to reduce adequately and appropriately the risk of transmission of RTTIs. This guidance provides recommendations for testing blood donations to reduce adequately and appropriately the risk of HBV transmission under these regulations.
Download the Guidance Document
