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510(k) Modifications Guidance Shows FDA Focus On Least- Burdensome Principle, Routine Risk Tests

Executive Summary

A final 510(k) modifications guidance released from US FDA contains at least nine changes in emphasis from an August 2016 proposal. It enunciates the agency's plan to abide by "the least burdensome principle" in evaluating sponsors submissions for changes, and it recommends that any decision by a company not to submit a new 510(k) after a device alteration be routinely verified and validated.


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