How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don\u2019t qualify for exemption and how that intersects with how a device is classed?
This is the focus of today\u2019s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.
Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exemptions, how classifications do and don\u2019t intersect with exemptions, and why some items are exempt.
\u201cAn exempt device, whether it\u2019s a Class I exempt or a Class II exempt device, it doesn\u2019t matter, is still a regulated medical device.\u201d
\u201cInstead of calling these special controls, we should call them specific controls.\u201d
\u201cOne of my frustrations with a lot of folks in this business is they just follow the regulations like a recipe, like a computer executing lines of code one by one without asking does this make sense?\u201d
\u201cWhat is much much more important than the answer is the logic you use to get the answer.\u201d
CDRH Website: Class I and Class II Device Exemptions
Webinar: When do we need FDA\u2019s permission to market our device and when do we not? (Nov 2020)
Webinar: Special Controls: What are they, and how can we use them to our advantage? (May 2022)
Webinar: Understanding the Medical Device Classification System (July 2020)
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