FDA Drafts New Rules for Safer Blood Hepatitis B Checks
Published Date: 7/16/2025
Notice
Summary
The FDA just shared new draft advice for blood centers on how to test donations for hepatitis B to keep blood safer. This update affects anyone who collects whole blood or plasma and aims to replace old testing rules from 2012 and 1987. Blood centers should get ready for these changes, which could improve safety without adding big costs or delays.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
New FDA Hepatitis B Testing Guidance
If you collect whole blood or blood components (including Source Plasma), the FDA has issued a draft guidance with recommendations for testing donations for hepatitis B surface antigen (HBsAg). The draft guidance, when finalized, is intended to supersede the October 2012 guidance and the December 1987 memorandum on HBsAg testing to reduce the risk of transfusion-transmitted hepatitis B virus (HBV).
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