FDA to Reclassify Most Class III IVDs as Class II, Easing Approval Pathway

CDRH plans to reclassify most in vitro diagnostic tests (IVD) from class III (high risk) to class II (moderate risk), enabling manufacturers to seek marketing clearance through the premarket notification 510(k) pathway than the more stringent premarket approval pathway.

Tests affected by this change are primarily infectious disease and companion diagnostic IVDs. The center says it will be proposing reclassification for those IVDs for which “there is sufficient information to establish special controls that, together with general controls, provide a reasonable assurance of safety and effectiveness.”

The change comes as the FDA seeks to take on oversight of lab developed tests through a proposed rule issued last September. Thousands of public comments on the proposed rule displayed a wide range of arguments in support and in opposition of the change.

Read more on the reclassification effort here.

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