FDA updates policy for nixing 510(k) submissions

By AuntMinnie.com staff writers

January 31, 2018 -- The U.S. Food and Drug Administration (FDA) has issued new guidelines on its policy for determining when it will refuse to accept submissions for new 510(k) applications for medical devices.

The FDA's refuse-to-accept (RTA) guidelines are designed to help the agency meet performance goals for the timeliness of medical device reviews without getting bogged down with submissions that don't meet its requirements for regulatory review. The new guidelines include provisions in the 21st Century Cures Act and replace the last guidance, issued in 2015.

The agency has also updated its refuse-to-accept guidelines for premarket approval (PMA) submissions. The agency will hold a webinar on March 20, 2018, to discuss the changes.

More information on the updated 510(k) guidelines is available by clicking here, while information on the new PMA policy is available by clicking here.


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