I still don’t take the wearable market seriously, but the FDA doesn’t share my skepticism.
Federal regulators are growing concerned that wearables are rapidly morphing from simple gadgets into medical devices, and on Tuesday the FDA issued a draft set of guidelines which try to define when a low risk product which promotes health management crosses into the territory of medical devices.
According to the draft guidelines, a general wellness product (like a wearable) becomes a medical device when it goes beyond the general goals of most wearables – to help people monitor their sleeping patterns, activity levels, food consumption, and medical stats.
Devices that claim any of the following aren’t general wellness devices according to the draft guidance:
- the product will treat or diagnose obesity;
- it will treat eating disorders, such as anorexia;
- it helps treat anxiety;
- a computer game that will diagnose or treat autism;
- a product that will treat muscle atrophy or erectile dysfunction;
- a product that will restore a structure or function impaired due to a disease, e.g., a claim that a prosthetic device enables amputees to play basketball.
Wearables which are designed to assist with weight, sleep, or stress management, but do not mention a specific condition or disease, will not be affected by the draft guidelines. Fitness wearables that are designed to build muscle mass, improve flexibility or sexual function, or increase aerobic activity are also exempt.
In short, the FDA is bringing the same scrutiny to wearables that food supplements receive. This is going to have all sorts of interesting effects on the marketing claims of some of the wearable makers – not that that is a bad thing.