Regulatory Guidance

FDA Clarifies Guidance on Health-tracking Wearables

Jan 20, 2015

The U.S. Food and Drug Administration has issued preliminary guidance that defines the agency's criteria for determining when wearables which provide health tracking or advice will be classified as regulated medical devices.

According to the draft guidance, wearables will not be considered medical devices unless they make claims about fitness to treat specific diseases or conditions --such as obesity, eating disorders, anxiety, autism, muscle atrophy, or erectile dysfunction -- or present inherent risks to consumers' safety.

This means that devices that fall under the "general wellness" category -- devices related to weight management, physical fitness, relaxation, stress management, self-esteem, etc. -- will not be considered medical devices, and thus will not be regulated. Most of the current wearable devices, such as FitBits, Jawbones and the anticipated Apple Watch, will fall into this category of general wellness.

Read the appleinsider article