Pathways' Pick of the Week: Mass Move of IVDs to 510(k) Route

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FDA says it plans to transition a large number of IVDs from the PMA to 510(k) pathway. Excerpted from Pathways’ Picks Feb. 7: FDA Panel Picks, More IVD 510(k)s Coming, EU AI Act Advances, and More.

FDA plans to move many IVD categories that currently require PMAs to the 510(k) pathway. In a January 31 announcement, FDA said it “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.” An agency spokesperson clarified to Market Pathways that “we might propose reclassification for at least 50% of CDRH-regulated Class III (high risk) IVDs.” She declined to provide the total number of current Class III IVDs or to provide a planned timeline for the reclassifications. A review by Market Pathways of CDRH’s classification database suggests there are currently about 70 Class III IVD product codes.

IVD regulatory experts speculated that the move is partially timed to prepare for FDA’s intended four-year phase-in of the regulation of thousands of laboratory-developed test (LDT) services, reducing the regulatory burden on reviewers and labs. FDA also said it expects most future companion diagnostics and infectious disease tests to qualify for Class II status via the De Novo process. “One can’t help but read this announcement as an effort by FDA to prepare for (or at least give the appearance of preparing for) the deluge of IVD premarket submissions the agency expects it will receive following (the presumed) finalization of its proposed rule regulating LDTs,” Hyman, Phelps & McNamara attorneys write an FDA Law Blog post, although they are skeptical the reclassification plans will provide much of a cushion.

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