Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices

Document 2024-21932 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on September 25, 2024. The Food and Drug Administration (FDA, the Agency, or we) is proposing to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative HBV antibody assays and quantitative assays that detect anti-HBs (antibodies to HBV surface antigen (HBsAg)), and quantitative HBV nucleic acid-based assays, all of which are postamendments class III devices, into class II (general controls and special controls), subject to premarket notification. FDA is also proposing three new device classification regulations along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for each device. View the original at https://www.federalregister.gov/documents/2024/09/25/2024-21932/microbiology-devices-reclassification-of-antigen-antibody-and-nucleic-acid-based-hepatitis-b-virus.

No. Document 2024-21932 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.