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FDA's Center for Devices and Radiological Health Plans Reclassification Process for High-Risk IVDs

NEW YORK — The US Food and Drug Administration said on Wednesday that its Center for Devices and Radiological Health (CDRH) is planning a process to reclassify some high-risk in vitro diagnostics as moderate risk in a move that the agency said would allow manufacturers to seek marketing clearance for their tests through a less stringent regulatory pathway.

According to the FDA, the majority of these high-risk — or Class III — tests are infectious disease and companion diagnostic IVDs. By reclassifying certain of them as moderate risk — or Class II — test makers could obtain clearance through the 510(k) premarket notification pathway rather than the more burdensome premarket approval pathway.

The CDRH will still conduct a premarket review of reclassified tests under the 510(k) pathway, the FDA added. It will also continue to take a risk-based approach in the initial classification of individual IVDs to determine the appropriate level of regulatory controls and whether a new test may be classified into Class II through de novo classification, rather than being Class III and subject to the premarket approval 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," CDRH Director Jeff Shuren said in a statement. "As such they would be regulated as Class II devices."

The CDRH has already started this planned process, such as with a September panel meeting where the potential future reclassification of various molecular and non-molecular infectious disease IVDs was discussed, the FDA said.