REGULATORY UPDATE: CDRH Plans to Reclassify Some High-Risk In-Vitro Diagnostics

The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) announced plans to reclassify the majority of high-risk in-vitro diagnostics (IVDs) from class III devices to class II moderate-risk devices. This move, announced by CDRH Director Jeff Shuren, MD, JD, last Wednesday, aims to streamline the regulatory process and facilitate quicker market access for certain types of tests.

Under the proposed change, manufacturers of select IVDs would be able to seek marketing clearance through the less burdensome premarket notification pathway (510[k]) instead of the agency’s more rigorous premarket approval (PMA) pathway. CDHR expects the reclassification to foster innovation and competition in the diagnostic testing space and increase patient access to IVDs.

Shuren highlighted the recent activities of a CDRH panel convened in September 2023, which discussed and recommended potential reclassification for three specific types of infectious disease diagnostic tests. These include nucleic acid and serology-based IVDs designed to aid in the diagnosis of hepatitis B virus, serology-based IVDs for detecting human parvovirus B19 and cell-mediated immune reactivity IVDs for identifying in vitro responses to peptide antigens associated with Mycobacterium tuberculosis infections.

Additionally, FDA will continue to classify new IVDs based on risk, potentially assigning them to the moderate-risk category with appropriate controls. In addition to the reclassification efforts, the FDA will continue its practice of classifying new IVDs based on their level of risk, with the possibility of assigning them to the moderate-risk category along with appropriate regulatory controls.