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FDA's New Position on Wearable Devices

The first months of any new year always bring a slew of health and fitness trends, and a growing trend in 2015, as the debut of the AppleWatch draws near, is wearable fitness devices. As this new technology grows in popularity, the regulations surrounding it remain murky. The U.S. Food and Drug Administration (FDA) has issued a draft outlining what the agency takes into account when considering whether these health trackers should be classified as medical devices, which would be subject to FDA regulation.

According to the FDA’s draft, which is currently in a 90-day comment period, wearables like the AppleWatch, would not be considered medical devices unless they make fitness claims for treating diseases or conditions, or present risks to the wearer’s safety. The FDA will allow certain claims within the category of “general wellness,” including those related to weight and/or stress management, physical fitness, mental sharpness, sleep management and relaxation. Alternately, devices that make claims regarding the treatment or diagnosis of diseases are in a different category and, therefore, are subject to FDA scrutiny.

Devices like the upcoming AppleWatch designed to track activity or biological information, such as the wearer’s pulse, are allowed to make certain health-related claims, like promoting physical activity as a way to reduce heart disease, without becoming subject to FDA regulation.

Alternatively, the following are examples of claims that do not fall into the category of “general wellness” claims:

  • A claim that a product will treat or diagnose obesity;
  • A claim that a product will treat an eating disorder;
  • A claim that a product helps treat anxiety;
  • A claim that a computer game will diagnose or treat autism;
  • A claim that a product will treat muscle atrophy or erectile dysfunction;
  • A claim to restore a structure or function impaired due to disease.

Basically, anything that can help you get a better diet or exercise routine, help you reach a goal weight, or otherwise adjusts your behavior will not need much in the way of regulation. This does not mean the FDA plans on not overseeing this genre of health tech as a whole, more that the list just does not include items like the AppleWatch, Fitbit or the like.

Instead, the FDA makes it clear that general wellness policy discussed above does not extend to devices that present inherent risks to a user’s safety. The guidance sets out factors the FDA will consider to identify a device as low risk. If the product is invasive, involves an intervention or technology that may pose a risk to a user’s safety if the device controls are not applied, raises novel questions of usability, or raises questions of biocompatibility, then the device is not covered by this particular guidance. With plenty more wearable technology with health-related aspects coming in the future, understanding these regulations will be vital in making sure developers and potential consumers are aware of the legal ramifications that may emerge.