🧫FDA Reclassifies Hepatitis B Assays, Easing Market Entry
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's reclassification of HBV assay devices from Class III to Class II reduces regulatory burdens for manufacturers, enabling quicker market access through premarket notifications rather than costly premarket approvals. This alteration can enhance device development and availability, directly affecting businesses and their operations in the medical device sector.