# #368: Institutional Review Boards (IRBs)

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-05-21
- Length: 49m
- Episode: 368
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-21-368-institutional-review-boards-irbs
- Listen: https://podcast.greenlight.guru/episode/368-internal-review-boards-irbs

## Summary

Dr. Mike Drues joins host Etienne Nichols to explain the role of Institutional Review Boards (IRBs) in medical device clinical trials, distinguishing between traditional and commercial IRBs. He details the critical difference between Significant Risk (SR) and Non-Significant Risk (NSR) devices, noting that while NSR devices are IDE-exempt, pre-submission meetings with the FDA are highly recommended to avoid costly endpoint surprises. Dr. Drues also advises on 'IRB shopping' when facing denials and emphasizes the importance of physician champions to facilitate patient enrollment.

## Outline

1. Introduction: Dr. Mike Drues and IRB Basics
2. Traditional vs. Commercial IRBs
3. Significant vs. Non-Significant Risk Devices
4. FDA Pre-Submission Strategy for NSR Trials
5. IRB Shopping and Label Expansion Nuances
6. Submission Structure and Patient Recruitment

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- MDDI (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/2024-05-21-368-institutional-review-boards-irbs. 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.