> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Proposal to Reclassify HBV Assays
- URL: https://www.fdaweb.com/fda-proposal-to-reclassify-hbv-assays/
- Published: 2024-09-26T12:00:00.000Z
- Updated: 2026-09-14T14:42:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157860

*Federal Register* notice: FDA is proposing to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative and quantitative HBV antibody assays, and quantitative HBV nucleic acid-based assays from Class 3 to Class 2 (general and special controls), subject to premarket notification. The agency is also proposing three new device classification regulations along with the special controls that it says are necessary to provide a reasonable assurance of safety and effectiveness for each device. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-09-25/pdf/2024-21932.pdf?ref=fdaweb.com).