By AuntMinnie.com staff writers

June 8, 2018 -- The U.S. Food and Drug Administration (FDA) has issued a draft guidance regarding medical device submissions.

The document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," explains how to request a meeting with the FDA regarding potential or planned medical device or device-led combination product submissions, the agency said.

When finalized, the guidance will replace the version issued in September 2017. The FDA is taking comments on the draft until August 6.


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