Q-Submission Program for Medical Device Submissions

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U.S. Food & Drug Administration
Saturday, May 11, 2019 | 3pm EDT (US and Canada) / May 12, 3am CST (China) / 8pm BST (UK) Long > 60 min | English

Webinar Details

The U.S. Food and Drug Administration (FDA) held this webinar to provide the final guidance for Medical Device Submissions: The Q-Submission Program. The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions.

This final guidance clarifies the ways submitters can request feedback or request a meeting with the FDA about potential or planned medical device or device-led combination product submissions. It also covers review of other submission types, such as submission hold letters.

Slides and a transcript are also available.

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Webinar Type: Recorded

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