FDA clarifies when health and fitness wearables should be considered medical devices

We know Apple’s upcoming Watch, due in March, will double as a fitness and a health tracking device, but could it be classed as a regulated medical device?

According to the preliminary guidelines published Tuesday on the United States Food and Drug Administration’s website, any wearable device which wants to be considered a medical device must prove that it can treat specific diseases or conditions, as first noted by AppleInsider.

If not, any such device should be considered a general wellness gadget, not a regulated medical device.

So-called low risk devices that promote a healthy lifestyle, or “general wellness products” as the documents collectively calls them, that pose a very low risk to users’ safety may include exercise equipment, audio recordings, video games, software programs and other products.

Specifically, “general wellness” wearables as defined by the FDA include devices related to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management or sexual function.

Activity trackers and wearables that keep track of users’ pulse are allowed to make certain, limited disease-related claims. An example given includes claims related to physical activity, which, as part of a healthy lifestyle, “may help reduce the risk of high blood pressure.”

On the other hand, health gadgets that claim to diagnose, or even treat certain conditions risk being scrutinized and subjected to regulation. Examples given include products that make claims regarding such conditions as obesity, eating disorders, anxiety, autism, muscle atrophy or erectile dysfunction.

There is indeed a very fine line for the FDA regulations of health-related devices based on their intended use. In one instance, a glucometer would be unregulated unless marketed directly to diabetics.

Apple has made a series of medical hires and has met repeatedly with FDA officials ahead of the September 2014 Apple Watch unveiling.

The FDA reportedly made it clear to Apple that apps which are purely educational or informational should be considered as diagnostic rather than medical.

The agency wanted to make sure that Apple is “on the side of the FDA” and that “the earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated.”

The FDA’s preliminary guidance is currently open for a 90-day public comment period.