The FDA’s Center for Devices and Radiological Health (CDRH) announced its intention to initiate the reclassification process for the majority of in vitro diagnostic devices (IVDs) currently classified as high risk (class III) into a moderate-risk category (class II). This move primarily targets infectious disease and companion diagnostic IVDs. Reclassification aims to allow manufacturers of these tests to seek marketing clearance through the less rigorous premarket notification (510(k)) pathway, as opposed to the more stringent premarket approval pathway.
CDRH Director Jeff Shuren emphasized that, despite the shift in classification, reclassified tests would still undergo a premarket review under the 510(k) pathway. The potential reclassification is expected to encourage more manufacturers to develop these critical tests, fostering competition and improving accessibility.
The reclassification process is already in motion, with discussions and recommendations made at a September 2023 panel meeting for three types of infectious disease diagnostic tests. These include nucleic acid and serology-based IVDs for Hepatitis B Virus (HBV) infection, serology-based IVDs for detecting human parvovirus B19, and cell-mediated immune reactivity IVDs for identifying in vitro responses to Mycobacterium TB infection.
CDRH aims to propose reclassification for devices where there is enough information to establish special controls, combined with general controls, ensuring the safety and effectiveness of these tests. This strategic move aligns with the FDA’s risk-based approach to classifying individual in vitro diagnostic devices, determining appropriate regulatory controls and considering the De novo classification for new tests, potentially classifying them as class II with established special controls.
The FDA’s periodic review of device classifications, including this reclassification effort, reflects its commitment to applying the least burdensome provisions while maintaining rigorous regulatory oversight. This initiative builds on previous reclassification efforts, such as the transition of certain Hepatitis C Virus Antibody Tests and Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests from class III to II.
As the reclassification process unfolds, the FDA pledges to keep the public informed, emphasizing transparency and adherence to the agency’s commitment to ensuring the safety and effectiveness of medical devices.