RQM+ Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device industry. The panelists also answer audience questions. Every episode is added to our podcast, too.
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The rules of requests for feedback and pre-submission meetings with FDA are covered under FDA Guidance Document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program," issued May 7, 2019.
The FDA Q-Submission (formerly known as pre-sub) Process can be intimidating, beginning with the decision as to whether to request a Q-sub at all. It's a great opportunity to align with FDA or pressure-test on critical items like predicate assignment or test plans before getting too far along in development and spend, however many fear that FDA is more critical of data in the Q-sub than they would be seeing it for the first time in a 510(k) submission. This uncertainty combined with the time commitment to have one often makes it difficult for an RA lead to get the product development team on board with a Q-sub strategy.
In this show, talk with our FDA submission experts including recent CDRH staff about when to use the pre-sub process, real and perceived risks associated with the process, tips and tricks to achieving a successful meeting, and case studies of our experiences.
Please bring your questions!
Here's the panel:
Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q