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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