Q-Submission Program for Medical Device Submissions
U.S. Food & Drug Administration
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.
Webinar Type: Recorded