Data / Federal rules / 2024-21932
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
The Food and Drug Administration published this proposed rule in the Federal Register on September 25, 2024. Comments closed on November 25, 2024.
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What the agency says
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.
Key facts
- Document number
- 2024-21932
- Type
- Proposed rule
- Action
- Proposed amendment; proposed order; request for comments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 25, 2024
- Comments due
- November 25, 2024
- Dates
- Either electronic or written comments on the proposed order must be submitted by November 25, 2024. Please see section X of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.
- Docket
- Docket No. FDA-2024-N-3533
- Code of Federal Regulations
- 21 CFR 866
- Topics
- Biologics; Laboratories; Medical devices
- Pages
- 14
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on biologics · Rules on laboratories · Rules on medical devices · Published in September 2024
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