Episode 292

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

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.”