Standards, Not Predicates Emphasized In Finalized Alternative 510(k) Pathway

Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons.

A newly finalized guidance document from US FDA emphasizes consensus standards rather than predicate comparisons for establishing substantial equivalence for 510(k) devices.

The new approach, which FDA is calling the "Safety and Performance Based Pathway," effectively expands the abbreviated 510(k) pathway as...

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