Shuren At FDLI: Least-Burdensome, Real-World Evidence Efforts Picking Up
US FDA's device-center head discussed his continued push to make regulations more flexible, plans for least-burdensome training and what's next for NEST, among other topics, at the Food & Drug Law Institute annual gathering in Washington DC.
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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.
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act. Here's a breakdown of where things stand in the implementation of key provisions.