IOM Floats Modified De Novo Reviews To Replace Device 510(k) Pathway

The Institute of Medicine floated replacing the embattled 510(k) medical device clearance pathway with a modified de novo review process — which is used for low-risk devices without a predicate — in light of concerns from several experts on the committee that the utilization of predicates does not properly measure safety and efficacy. Device manufacturers support de novo reforms, but industry sources said the use of predicates should not be abandoned and expressed concerned about suggestions for more clinical data in the 510(k) pathway.

An IOM panel recommended replacing the 510(k) clearance process, saying the agency should move away from the current framework “as soon as reasonably possible,” the group of experts said in a report released last week. That proposal was one of eight listed in the report, but in a separate recommendation, the panel also cited a modified de novo process as a candidate to replace the 510(k) pathway and called on FDA to start a pilot.

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