The Food and Drug Administration (FDA) has proposed reclassifying antigen, antibody, and nucleic acid-based hepatitis B virus (HBV) assays to a lower-risk classification. This move aims to streamline the regulatory pathway for these diagnostic tools while maintaining patient safety.
Currently, these tests are classified as Class III, or high-risk devices, necessitating premarket approval. The FDA is considering moving them to Class II, or moderate-risk, making them eligible for the 510(k) pathway, according to a notice published in the Federal Register. This proposed change reflects the FDA’s accumulated experience in regulating these assays and its analysis of postmarket data.
The FDA approved the first qualitative HBV antibody assay in 2000, followed by the first HBV antigen assay in 2001 and the first quantitative HBV nucleic acid-based assay in 2008. At that time, the agency determined that there was insufficient information to assure safety and effectiveness through general and special controls alone. However, the FDA now believes it possesses sufficient data to mitigate the risks associated with these devices through the implementation of special controls.
Rationale for Reclassification
The decision to reclassify is underpinned by the FDA’s analysis of medical device reports and recalls, which indicates a good safety record for each of the three types of HBV assays. While the FDA has received reports of false readings and classified recalls, there is a lack of evidence suggesting patient harm resulting from these issues. The probable risks to health identified by the FDA primarily relate to false positive and negative results, misinterpretation of results, and failure to correctly operate the devices.
Proposed Special Controls
To mitigate these risks, the FDA is proposing special controls related to labeling and design verification. These controls include detailed labeling warnings, clear limitations, comprehensive results interpretation information, and thorough explanations of procedures to address potential misuse risks. The FDA is accepting feedback on the proposal until November 25, with plans to reclassify the assays 30 days after the publication of the final order in the Federal Register.
