Hardware Podcasts

#368: Institutional Review Boards (IRBs)

Global Medical Device Podcast · 21 May 2024 · 49m · Episode 368

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, MDDI

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