Hardware Podcasts

What "Exempt" Means with Respect to Medical Devices & Regulatory

Global Medical Device Podcast · 30 Nov 2022 · 52m · Episode 292

What this episode covers

Mike Drues, President of Vascular Sciences, joins host Jon Speer of Greenlight Guru to clarify the regulatory meaning of 510(k) exemptions for medical devices. Drues explains that 'exempt' does not mean unregulated; exempt devices remain subject to general controls and quality systems, but are not subject to formal pre-market review like a 510(k) submission. The conversation distinguishes between Class I and Class II devices, noting that while most Class I devices are exempt, some Class II devices are also exempt if specific controls are sufficient. Using examples like scalpels, wheelchairs, and blood refrigerators, Drues illustrates how intended use, labeling, and technology determine classification and exemption status.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, ISO 13485, ISO 14971, G2

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