Reminder: Join us tomorrow for a Webinar on the Q-Submission Final Guidance

On Tuesday, June 11, 2019, from 3:00 – 4:30 PM, EST the FDA will hold a webinar to provide additional information on this final guidance document and provide participants an opportunity to have questions answered by subject matter experts on this topic.   On May 6, 2019 the U.S. Food and Drug Administration (FDA) issued 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.

Webinar Details Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.