FDA Publishes Draft Guidance for Fitness Trackers, Smartwatches

Posted by at 6:49 am on January 20, 2015

Jawbone Fitness trackersThe US Food and Drug Administration (FDA) is taking an interest in wearable devices, specifically those offering fitness tracking capabilities. Draft guidance published by the FDA concerning “Low Risk General Wellness Products” suggests the administration is looking into whether or not it needs to regulate new devices that aim to improve the health of the user.

The document spotted by VentureBeat suggests that the FDA will be allowing most fitness trackers to be sold with little in the way of restrictions. So long as a product is “intended for only general wellness use” and presents “a very low risk to users’ safety,” it will be out of the FDA’s crosshairs, so in theory the majority of fitness trackers should escape any major regulatory interference.

As for the definition of “general wellness use,” it basically boils down to whether the device is claimed to diagnose or treat certain ailments, such as eating disorders, autism, or anxiety, or not. Devices that provide more generalized claims, including tracking activities and sleep management, without giving a claim that it can be used to treat a condition, fit under the general wellness classification. Disease-specific claims could still be used, but with language suggesting it only promotes, tracks, or encourages choices that can help “reduce the risk” of specific chronic conditions from occurring as part of a healthy lifestyle.

The “low risk” aspect relates to how the product operates directly with the user, with the FDA asking if it is invasive, has possible issues with biocompatibility, uses a technology that could pose a risk to the user if certain controls are not applied, or “raises novel questions of usability.” A fitness tracker keeping track of the user’s pulse typically classes as low risk.

The published item is still only a draft and does not yet apply to devices currently being produced, but the FDA is asking for comments on the guidance until April 20, and it could still change before manufacturers have to take the rules into account.

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