Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
fda-device · Food and Drug Administration · Rule · Published 2025-09-18 · Effective 2025-10-20 · 90 FR 44969
Document
Document number
2025-18082
Federal Register citation
90 FR 44969
CFR reference
21 CFR 866
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2025-09-18
Effective date
2025-10-20
HHS docket
Docket No. FDA-2024-N-3533
Abstract
The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.