FDA finalizes hepatitis B blood-donation testing guidance
Published November 8, 2026 · Coverage November 1–7, 2026, Pacific · Lower priority
FDA announced a final guidance, Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus (Docket FDA-2024-D-5942), that finalizes a July 2025 draft and supersedes several earlier hepatitis B virus (HBV) memoranda and guidances. FDA recommends that when donations are tested for HBV DNA by nucleic acid tests (NAT) and for antibody to hepatitis B core antigen (anti-HBc) with FDA-licensed, approved or cleared screening tests used in accordance with the manufacturer's instructions, hepatitis B surface antigen (HBsAg) testing is not necessary. That does not apply to Source Plasma, for which HBsAg and HBV DNA NAT testing continue to be recommended. The guidance is nonbinding. The guidance itself, dated November 2026, says licensed blood establishments that discontinue testing donations for HBsAg, make conforming changes to donor requalification, revise their circular of information or make other changes to their standard operating procedures (SOPs) consistent with its recommendations must report the change in an annual report under 21 CFR 601.12(d), noting the date of implementation; unlicensed blood establishments do not need to report those changes to FDA. It considers an HBV testing strategy or other procedures other than as recommended to be a major change, for which licensed blood establishments must submit a prior approval supplement under 21 CFR 601.12(b).
Background
FDA announced a draft of this guidance in the Federal Register of July 16, 2025, titled Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen, and considered the comments it received as the guidance was finalized. The final guidance also consolidates FDA's recommendations for hepatitis B virus testing of blood and blood components that had been issued previously in various memoranda and guidance documents.
Who this affects
Hospital-based blood establishments that collect Whole Blood and blood components.
Why it matters
Inference: hospital blood collection programs may update donor testing algorithms, donor requalification and labeling SOPs; any change to a licensed establishment's procedures may require reporting under 21 CFR 601.12, which the notice references.
Required actions
- Licensed blood establishments that discontinue HBsAg testing, make conforming changes to donor requalification, revise their circular of information or make other SOP changes consistent with the guidance report the change in an annual report under 21 CFR 601.12(d), noting the date of implementation; an HBV testing strategy or other procedures other than as recommended is a major change that needs a prior approval supplement under 21 CFR 601.12(b). Unlicensed blood establishments do not need to report those changes to FDA.
Recommended action
- Laboratory / Blood Bank: compare current HBV donor testing and requalification SOPs with the final guidance.
Scope and timing
- Authority status
- Guidance
- Responsible owner
- Laboratory / Blood Bank
- Publication date
- 2026-11-03
- Other dates
- Finalizes July 2025 draft guidance; comments on guidance accepted at any time
Not established
No date by which establishments are to make these changes was found in the guidance.
Sources
Complete edition and supplemental material
This article in the complete report →
Executive triage, source-coverage limitations, context and forward horizons remain in the complete report.
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