The U.S. Food and Drug Administration (FDA) has published a draft guidance note stating that wearable devices accompanied by health claims could possibly come under agency scrutiny in the near future. While the note is not yet legally binding and at this stage is still requesting opinions from the public, it could possibly mean extensive red tape for fitness and health wearables that have been gaining traction in the marketplace. These accessories often straddle a fine line between casual accessories that encourage better health habits and more serious medical equipment traditionally overseen by the FDA.
The draft guidance note states that “general wellness devices” that persuade wearers to pursue healthier lifestyles, which could include wearables such as Fitbit wellness trackers and machines like the Aura Smart Sleep System, don’t yet pose a threat to the public. But when a device makes specific medical claims, such that it treats obesity, autism or another disorder, or if it’s physically invasive or could even be categorized as a prosthetic, it will be subject to FDA regulations.