Fitness trackers versus medical devices: What’s the difference?

[Image from Unsplash]

Recent research studies have been calling into question the accuracy of fitness trackers. So when would FDA step in and regulate them as medical devices?

It all comes down to the difference between low-risk general wellness devices and medical devices – a distinction covered in an FDA guidance document last year, said Michael Drues, a Boston-based regulatory consultant who has worked for both device companies and FDA.

“The technology of the device really matters very little. What is much more important is the labeling. … It is all about what we say about our device, not necessarily what it does or how it works,” said Drues, who is president of Vascular Sciences.

Get the full story on our sister site, Medical Design & Outsourcing.

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