# Making Your Informational Meetings with FDA Valuable & Worthwhile

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-03-30
- Length: 36m
- Episode: 252
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile
- Listen: https://podcast.greenlight.guru/episode/making-your-informational-meetings-with-fda-valuable-worthwhile

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=0) Introduction: Isabella Schmitt, Proxima and M1 MedTech
- [2:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=130) Defining Informational Meetings vs. Pre-Submissions
- [7:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=472) FDA Reviewer Flux and Relationship Building
- [10:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=600) Preparation and Interpreting FDA Feedback
- [14:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=867) Addressing Companies with Limited Resources
- [18:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=1085) Cost, Time Commitment, and Scheduling
- [23:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=1383) Impact of Pandemic Resources on IVD Division
- [26:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=1590) The Need for Regulatory Interpreters
- [33:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile#t=2023) Mitigating Uncertainty for Startups

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Green Light Guru (company)
- M1 MedTech (company)
- FDA (other)
- Q-Submission Program (other)

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## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-30-making-your-informational-meetings-with-fda-valuable-worthwhile. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.