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

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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.

A claim that a wellness device lowers blood pressure would likely get FDA’s attention. But an inferred or implied claim that exercise and a healthy diet generally lowers blood pressure could pass muster.

There may even be a strategy in which a company get a device into the public eye as a wellness product, and then seeks FDA permission to market it as a medical device.

Regulatory experts and additional eyes can help determine whether a product is a wellness device or a medical device. Eventually, the device could be run by FDA staff in a presubmission meeting.  “My attitude is if there’s going to be a problem, it’s better to find out about it sooner than later,” Drues said.

No matter what, makers of wellness products also have an obligation to avoid sloppy engineering, a recent Stanford University study raised eyebrows because it found major inaccuracies in fitness tracker calorie burning numbers. “I strongly believe it’s possible to have a profitable business and still do the proper engineering at the same time,” Drues said.

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