FDA Downgrades Hepatitis B Tests to Faster Approval Category
Published Date: 9/18/2025
Rule
Summary
The FDA is changing the rules for certain hepatitis B test devices, moving them from a strict category (Class III) to a less strict one (Class II) with special safety rules. This affects companies making HBV antigen, antibody, and nucleic acid tests, who now need to follow new guidelines and submit notifications before selling. These changes help speed up access to safe, reliable hepatitis B tests without extra costs or delays.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Manufacturers Must File Premarket Notices
If you make hepatitis B test devices, the FDA moved certain tests into class II and says you must follow new special controls and submit a premarket notification before marketing. This applies to qualitative HBV antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT).
Easier Access to Hepatitis B Tests
If you need a hepatitis B test, the FDA reclassified certain HBV antigen, antibody, and nucleic acid tests to class II with special controls and now allows them to be marketed after premarket notification. This change is meant to help speed access to safe, reliable hepatitis B tests for patients because those device types are now subject to the class II pathway.
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