Hardware Podcasts

Understanding the Investigational Device Exemption (IDE) Process

Global Medical Device Podcast · 31 Mar 2021 · 57m · Episode 192

What this episode covers

David Pudwill, known as 'Mr. Regulatory,' explains the Investigational Device Exemption (IDE) process to Jon Speer, detailing when an IDE is required, the distinction between exempt, non-significant risk, and significant risk studies, and the specific contents of an IDE application. Pudwill emphasizes that while 510(k) devices often don't require clinical data, high-risk or novel devices likely will, and he outlines the 12 mandatory components of an IDE submission and the FDA's 30-day review timeline. The conversation covers strategic advice on using Q-Submissions to clarify risk determinations, managing IRB interactions, and navigating post-approval reporting requirements to ensure a smooth path to market.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Also
FDA, Mr. Regulatory, David Pudwill, Jon Speer, Green Light Guru Academy, 21 CFR Part 812, Q-Submission Program, 510(k), PMA, De Novo, IRB

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