FOR IMMEDIATE RELEASE
January 31, 2024
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH)
As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for most IVDs that are currently class III (high risk) into class II (moderate risk). 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)) pathway rather than the premarket approval pathway, the most stringent type of FDA medical device review.
Notably, 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.
CDRH intends to propose reclassification of devices for which we believe there is sufficient information to establish special controls that, together with general controls, provide a reasonable assurance of safety and effectiveness for these tests.
CDRH has already started this process. For example, 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 the 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.
In addition to the reclassification process, we will continue taking a risk-based approach in the initial classification of individual in vitro diagnostic devices to determine the appropriate level of regulatory controls and whether a new test may be classified into class II through De novo classification (and special controls established), rather than being Class III and subject to the PMA pathway. Based on our experience, we believe that special controls could be developed, along with general controls, that could provide a reasonable assurance of safety and effectiveness for most future companion diagnostic and infectious disease IVDs. As such they would be regulated as class II devices.
As part of the agency’s least burdensome provisions, the FDA periodically reviews the classification of devices to ensure they are being regulated in the appropriate class (class III, II, I) with the necessary level of regulatory controls. CDRH has previously undertaken reclassification efforts as part of our systematic approach, including our 2014-2015 Strategic PrioritiesExternal Link Disclaimer, and as part of our regular due diligence in considering the specific classification for a particular device type. This includes the reclassification of certain Hepatitis C Virus Antibody Tests and Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests from class III to II.
As new information becomes available, we will communicate publicly.
