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

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.

Tags

cybersecurity, Rule, Health and Human Services Department, Food and Drug Administration

Related exam domains

CISSP 8: Software Development Security; CISM 4: Incident Management

Source record id

2025-18082

First seen by InfoSec Signals

9/23/2026

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