Hardware Podcasts

Making Your Informational Meetings with FDA Valuable & Worthwhile

Global Medical Device Podcast · 30 Mar 2022 · 36m · Episode 252

What this episode covers

Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech, explains the strategic value of FDA informational meetings for medical device companies. She distinguishes these early-stage, non-binding discussions from formal pre-submissions, noting they are ideal for complex products or when a company lacks specific data to support formal questions. Schmitt highlights that these meetings allow sponsors to build relationships with FDA reviewers and subject matter experts, who often attend because they enjoy geeking out over new technologies without the pressure of providing binding answers. The conversation covers preparation strategies, such as rehearsing pain points, and how to interpret FDA feedback to streamline future submissions and avoid costly supplements.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Green Light Guru, M1 MedTech
Also
FDA, Q-Submission Program

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