FDA planning to reclassify hepatitis B assays

The FDA plans to reclassify hepatitis B virus (HBV) assays from high-risk class III devices to moderate-risk class II, allowing them to use the 510(k) pathway for approval. Currently, these antigen, antibody, and nucleic acid-based tests require stringent premarket approval. This proposal stems from the FDA’s regulatory experience and postmarket data analysis, with plans to implement special controls for the tests.

Since the first qualitative HBV antibody assay was approved in 2000, followed by others in 2001 and 2008, the FDA now believes it can adequately mitigate risks through special controls. Despite reports of false readings and recalls, there’s no significant evidence of patient harm. Identified risks mainly involve false results and device misuse. The FDA aims to address these through enhanced labeling and design verification to improve safety and effectiveness.