• FDA Defines its Regulatory Stance on Wearables That Make Health Claims

    The US Food and Drug Administration recently issued preliminary guidance for what defines the agency’s criteria for determining when wearables which provide health tracking and/or advice such as the upcoming Apple Watch, could be classed as regulated medical devices. According to the draft, which is currently open for a 90-day public comment period, wearables won’t be considered medical devices unless they make claims about fitness to treat specific diseases or conditions, or alternatively present inherent risks to consumers’ safety. Claims that the FDA will allow under the umbrella of “general wellness” are those related to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management or sexual function.

    As of right now, any device which makes claims regarding the treatment or diagnosis of diseases or conditions such as obesity, eating disorders, anxiety, autism, muscle atrophy, or erectile dysfunction won’t be considered in this category and will end up facing FDA scrutiny. Additionally, devices which track activity or biological information such as the wearer’s pulse may make certain disease-related claims when its generally understood that a healthy lifestyle will reduce the risk of contracting a disease or aid in its management. This in particular is something consumers will have to be wary about because this can mislead consumers who aren’t aware of what is going on. The FDA went on to note that any device which is invasive or poses a risk to the user without sufficient control or alternatively raise “novel questions of usability” or biocompatibility will not fall under these guidelines.

    As of right now, few if any of the current top wearable devices appear to violating the rules. On its behalf, Apple is known to have met repeatedly with FDA officials prior to unveiling the Apple Watch, likely to ensure that the device would meet any forthcoming regulatory requirements due to its strong focus on health tracking. Furthermore, the FDA stated the following after the release of iOS 8 and the new Health app; Apple "wants to make sure they are on the side of the FDA" and that "the earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated."

    The FDA’s whole announcement comes at the heels of what analysts are predicting to be a boom when it comes to wearables. We’ll have to see how the rules hold up or if the FDA will end up revising them in the near future.

    Source: FDA via AppleInsider - Image via Stratos
    This article was originally published in forum thread: FDA Defines its Regulatory Stance on Wearables That Make Health Claims started by Akshay Masand View original post
    Comments 1 Comment
    1. SpiderManAPV's Avatar
      SpiderManAPV -
      I'm not sure I want to know what kind of wearable tech is supposed to cure erectile dysfunction.
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