Webinar Materials

• Webinar Recording
• Printable Slides
• Transcript

Summary: On Tuesday, June 11, 2019, the U.S. Food and Drug Administration (FDA) will host a webinar on the final guidance Requests for Feedback and Meetings 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 available ways submitters can request feedback or a meeting with the FDA about potential or planned medical device or device-led combination product submissions. It also provides an opportunity for submitters to discuss issues communicated by the FDA during review of other submission types, such as submission hold letters.