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510(k) Data Debated In Comments On FDA Draft Guidance

Device companies say non-clinical data should be given more prominence in FDA guidance on benefit-risk factors to consider when determining substantial equivalence of 510(k) devices with different technological characteristics from a predicate. But a coalition of consumer groups argues that the draft guidance underplays the need for clinical data.

Disagreement between industry and consumer groups over the frequency that clinical trial data should form the basis of a 510(k) for a device with different technological characteristics from the predicate was evident in comments submitted on a recent FDA draft guidance.

Device companies say non-clinical data should be given more prominence in the final version of the guidance on benefit-risk factors to consider when determining substantial equivalence of 510(k) devices with different technological characteristics from a predicate

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