The FDA has released its draft guidance on wearable devices, stating that most devices would not be regulated.

The guidelines, announced as the release of the Apple Watch approaches, draw a distinction between the types of products that will fall under the yoke of regulation. The FDA commented that they would not be concerned with regulating ‘general wellness products’, defined as:

"…products that (1) are intended for only general wellness use, as defined in this guidance, and (2) present a very low risk to users’ safety."

They go on to define these ‘general wellness’ devices as those that do not claim to target any specific medical condition. Under the guidelines, a device that claims to prevent or diagnose obesity would be regulated, since obesity is a medical condition, whereas a wearable relating to relaxation or stress management would not be.

The news will be music to the ears of aspiring wearable manufacturers, who by and large will be reassured that they will not face significant regulatory hurdles.