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FDA Listens To Industry Feedback On 510(k) Modifications Guidance Revisions

In a report to Congress, FDA stuck with device industry recommendations to merely revise its 1997 guidance on 510(k) device modifications, rather than to more thoroughly revamp the policy.

FDA is sticking with the foundation of its 1997 guidance on 510(k) device modifications, with plans for targeted revisions that follow device industry feedback, the agency said in a report to Congress.

The 1997 guidance is a “solid foundation and should remain mostly unchanged,” FDA said in the report, publicly released Feb. 25, but signed by Commissioner Margaret Hamburg Jan....

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