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June 7, 2018
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FDA Q-Submission Program Draft Guidance

June 7, 2018
FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...
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