FDA Clarifies its Regulatory Stance on Health Tracking Wearable Devices

FDA Clarifies its Regulatory Stance on Health Tracking Wearable Devices

As the debut of Apple’s new Apple Watch looms on the horizon, the U.S. Food and Drug Administration has issued their preliminary regulatory stance on health tracking wearables.

FDA Clarifies its Regulatory Stance on Health Tracking Wearable Devices

AppleInsider:

According to the draft — which is currently open for a 90-day public comment period — wearables will not be considered medical devices unless they make claims about fitness to treat specific diseases or conditions, or present inherent risks to consumers’ safety.

Claims that the FDA will allow under the catch-all of “general wellness” are those related to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.

If a device makes claims about the treatment or diagnosis of diseases and conditions such as obesity, eating disorders, anxiety, autism, muscle atrophy, or erectile dysfunction, it can expect to face scrutiny from the agency.

Devices which track activity or biological information can make certain disease-related claims when it’s also understood that a healthy lifestyle will reduce the risk of contracting a disease or aid in managing of said disease.

Apple has reportedly met repeatedly with FDA officials during the development of the Apple Watch, so the new wearable device likely won’t run afoul of any of the FDA rules and regulations.

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