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- FDA’s CDRH Announces Reclassification Process for Most High Risk IVD
On February 1, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) announced it started the reclassification process for most in vitro diagnostics (IVDs) that are currently class III (high risk) into class II (moderate risk). The CAP is analyzing this latest action by the FDA to understand the impact this will have on pathologists and laboratories. The majority of these tests are infectious disease and companion diagnostic IVDs.
Reclassification would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510 (k) premarket notification pathway) rather than the premarket approval pathway, the most stringent type of FDA medical device review.
The CDRH would still be conducting a premarket review of reclassified tests under the 510(k) pathway. Such reclassifications may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests, the FDA said.
The CDRH began this process several months ago. At a September 2023 panel meeting, the panel discussed and made recommendations regarding a potential future reclassification from class III to class II with special controls of three types of infectious disease diagnostic tests:
- Nucleic acid & serology based IVDs to aid in the diagnosis of Hepatitis B Virus (HBV) infection and/or for use to aid in the management of HBV infected patients.
- Serology-based IVDs to aid in detection of human parvovirus B19.
- Cell-mediated immune reactivity IVDs to aid in the identification of in vitro responses to peptide antigens that are associated with Mycobacterium TB infection &/or use as detection of effector T cells that respond to stimulation by M. tuberculosis agents.