With more and more health-focused "smart" wearables hitting the market, and some of them coming close to being serious medical devices, the FDA has issued some draft guidelines on what kinds of wearables it will consider regulating.
Most such wearables are considered low-risk "general wellness" devices meant to promote healthy lifestyles and as such won't require any FDA approval or regulation, the agency said in a draft guidance note.
Such products have "an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or ... an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions," the note says.
Fitness trackers such as FitBit and smart watches such as the Pebble or Apple Watch, which attempt to promote a healthy lifestyle through coaching and awareness, will not be subject to regulation under federal food, drug or cosmetic safety laws, the FDA says.
The agency said it created the draft guidance note -- which is not as yet legally binding and includes a 90-day public comment period -- in response to inquiries from wearable device as a way to clarifying which kinds of devices can be sold without FDA involvement versus what kinds might need tighter regulation.
As long the device offers just general advice, coaching or tracking of "basic wellness" concepts, such as weight, fitness, relaxation or mental acuity, they will not come under FDA regulations, according to the note.
The FDA emphasizes that it will not be approving or endorsing any such devices, just that it will not be regulating them.
However, any device that makes specific claims about treating a recognized disease or medical condition -- such as obesity -- would be subject to FDA regulation, since obesity is classified as a medical condition.
Any product claiming to treat conditions including obesity, anxiety, eating disorders or autism, especially if the claimed treatment presents some risks, will be considered a medical device subject to oversight, the FDA says.
Any device that is "invasive" or "involves an intervention or technology that may pose a risk to a user's safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants," would be subject to approval and regulation, it says.
