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  5. Webinar - Q-Submission Program for Medical Device Submissions - June 11, 2019 - 06/11/2019 - 06/11/2019
  1. Workshops & Conferences (Medical Devices)

Webcast

Event Title
Webinar - Q-Submission Program for Medical Device Submissions - June 11, 2019
June 11, 2019

Date:
June 11, 2019
Time:
03:00 PM - 04:30 PM EDT

Webinar Materials

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.