Hardware Podcasts

3 Systems of Risk for Medical Devices from FDA

Global Medical Device Podcast · 7 Apr 2021 · 39m · Episode 194

What this episode covers

Mike Drues of Vascular Sciences joins host Jon Speer to explain the FDA's three distinct systems for managing medical device risk: product classification (Class I-III), significant vs. nonsignificant risk (SR/NSR) for clinical trials, and software level of concern (Class A-C). Drues argues that these systems are independent yet interdependent, noting that the default Class III status for novel devices often misrepresents actual risk, as seen with the 'Band-Aid' example. He emphasizes that labeling claims can drastically alter a device's classification and risk status, and advises companies to use pre-submissions to align with the FDA before determining SR/NSR status.

Most relevant to

established companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru
Products
Band-Aid
Also
FDA

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