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

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How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed?

This is the focus of today’s 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’t intersect with exemptions, and why some items are exempt.

Some of the highlights of this episode include:

  • The meaning of 510(k) exempt
  • Why “exempt” may not be the best word
  • What unregulated medical devices are called
  • Classifications don’t necessarily mean that a device is exempt
  • Comparing and contrasting Class I and Class II
  • The difference between general controls and special controls
  • Examples of exemptions and why they’re exempt
  • The shades of gray in regulation
  • The regulatory logic

Memorable quotes from Mike Drues:

“An exempt device, whether it’s a Class I exempt or a Class II exempt device, it doesn’t matter, is still a regulated medical device.”

“Instead of calling these special controls, we should call them specific controls.”

“One 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?”

“What is much much more important than the answer is the logic you use to get the answer.”

Links:

Mike Drues LinkedIn

CDRH Website: Class I and Class II Device Exemptions

List of Exempt Devices by regulation number (CDRH Website): Medical Device Exemptions 510(k) and GMP Requirements

Webinar: When do we need FDA’s 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)

Webinar: General Wellness Devices and Wearables (May, 2018)

Jon Speer LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru

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