With so many health-focused wearables hitting the market, the U.S. Food and Drug Administration is clarifying which of them can skate by without tighter regulations.
Under the proposed guidance, the FDA’s Center for Devices and Radiological Health won’t examine what it considers “low risk general wellness” devices. If all the device does is promote better health through awareness and coaching—as fitness trackers from Fitbit and Jawbone do—they’ll be free from scrutiny under federal food, drug, and cosmetic safety laws.
Note that the guidance don’t really cover whether the product does what it claims to do, at least for basic wellness concepts such as fitness, weight, relaxation, mental acuity and sexual function. As Engadget notes, the FDA is mainly concerned with products making specific medical claims, and having some risk attached to the treatment.
For instance, a tanning product that uses ultraviolet radiation would cross into medical device territory, as would a skin treatment product that uses lasers. Generally, if a product claims to treat obesity, eating disorders, anxiety, autism or muscle atrophy, and there’s some risk involved in the treatment, the FDA will consider it a medical device. The same is true for prosthetics and other devices that claim to restore functions impaired due to disease.
The FDA says it drafted the guidance because it gets a lot of inquiries from device makers and wants to point them in the right direction. It’s open to a 90-day comment period.
Why this matters: While the vast majority of health and wellness trackers on the market today won’t require FDA oversight, we’re starting to see a more diverse range of devices aimed at niche audiences. Meanwhile, some of these devices are moving from basic monitoring and advice to actual treatment. As these trends continue, it’s only going to become more important to define which devices deserve greater scrutiny.