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June 8, 2018 -- The U.S. Food and Drug Administration (FDA) has issued a draft guidance regarding medical device submissions.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

Copyright © 2018

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