Live! #15 — When to use the FDA Q-Submission (Pre-Sub) Program

This is the audio-only version of DEVICE LOVE Live! #15, originally recorded August 13, 2020.

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.

Here's the panel:

Nancy Morrison — Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q Kevin Go — Senior Engineer (former FDA CDRH Lead Reviewer), R&Q Bryan Pinder — Project Engineer (former FDA CDRH Lead Reviewer), R&Q Carol Vierling — Senior Principal Advisor, Consulting Services, R&Q

Moderator:

Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q

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