FDA Refreshes Blood-Safety Guidance Dating Back to the 1980s
Published Date: 11/3/2026
Notice
Summary
The FDA just released new rules to help blood centers better test for hepatitis B, making blood transfusions safer for everyone. Blood banks must follow these updated testing steps starting soon, replacing old guidelines from as far back as the 1980s. These changes aim to catch infections earlier without causing big cost spikes, keeping our blood supply super safe and reliable.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
HBsAg Testing Not Required When NAT + anti‑HBc Used
If you operate a blood collection establishment, the FDA recommends that when donations are tested for hepatitis B virus (HBV) DNA by nucleic acid tests (NAT) and for antibody to hepatitis B core antigen (anti‑HBc) using screening tests that FDA has licensed, approved, or cleared and used per the manufacturer's instructions, testing for hepatitis B surface antigen (HBsAg) is not necessary to adequately reduce the risk of transfusion‑transmitted HBV. This recommendation is part of the final guidance published November 3, 2026, which finalizes the July 2025 draft guidance.
Source Plasma: HBsAg and HBV NAT Still Required
If you collect Source Plasma, the FDA continues to recommend testing Source Plasma donations for both hepatitis B surface antigen (HBsAg) and HBV DNA by nucleic acid tests (NAT) to adequately and appropriately reduce the risk of transfusion‑transmitted HBV. This continuation is stated in the final guidance announced in the Federal Register on November 3, 2026.
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