How General Wellness Devices Have Opened a Pandora's Box of Confusion

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor your heart rate, lose weight, or count calories? Are these smart technologies considered medical devices, general wellness devices, or both?

In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss the pros and cons, go-to-market pathways, and other considerations for general wellness products.

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Some highlights of this episode include:

• FDA does not regulate or classify general wellness devices that don’t diagnose, treat, or prevent a disease, injury, or condition.
• General wellness devices are required to do what they claim to do through prudent engineering.
• A general wellness device can still be considered a medical device, which creates confusion and false claims.
• Should manufacturers take the wellness or regulated route? Try both by putting versions of the same device on the market at the same time.
• Dumbed-down vs. stronger labeling: If the technology and risk are the same, how can FDA treat the same device differently?
• A wellness device exemption justification describes the device to explain how it meets labeling, technology, and risk requirements.
• FDA does not have a wellness device database to address problems by requiring pre-submissions, registrations, notifications, or other options.
• If Mike is “too busy” to help, that’s his code for, “You’re not doing what you should be doing.”

Links:

General Wellness: Policy for Low Risk Devices

Code of Federal Regulations (CFR)

De Novo Pathway: Explaining the Process for Medical Device Companies

Advanced Strategies and Tactics for Using the De Novo Pathway

FDA De Novo Program

FDA Premarket Notification 510(k

Fitbit

Apple Watch

Mike Drues

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru

Memorable Quotes From This Episode:

“A wellness medical device is not a regulated medical device. It does not diagnose, treat, prevent a disease, injury, or condition.” Mike Drues

“When FDA originally released the guidance for the wellness exemption...either purposefully or inadvertently, you’ve opened up a Pandora’s Box.” Mike Drues

“A lot of people are looking at this as a loophole that they can avoid the compliance and the regulation side of things as a fast path to get something on the market.” Jon Speer

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