With Apple Watch near, FDA clarifies regulatory stance on health-tracking wearables

Posted:
in Future Apple Hardware edited January 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, such as the forthcoming 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 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. Among the 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.

Devices which make claims regarding the treatment or diagnosis of diseases or conditions such as obesity, eating disorders, anxiety, autism, muscle atrophy, or erectile dysfunction will not be considered in this category and will face FDA scrutiny.

Additionally, those devices which track activity or biological information, such as the wearer's pulse, may make certain disease-related claims when it generally understood that living a healthy lifestyle will reduce the risk of contracting that disease or aid in its management. For instance, promoting "physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure" would be allowed and would not subject that device to regulation.

The FDA also notes that devices which are invasive, pose a risk to the user without sufficient controls (such as lasers), or raise "novel questions of usability" or biocompatibility will not fall under these guidelines.

Few, if any, of the current crop of wearable devices appear to run afoul of these rules. For its part, Apple is known to have met repeatedly with FDA officials in the run-up to the Apple Watch's unveiling, likely to ensure that the device would meet any forthcoming regulatory requirements due to its strong focus on health tracking.

Following the release of iOS 8 and its new Health app, the agency said when asked about the meetings that 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."
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Comments

  • Reply 1 of 34
    pmzpmz Posts: 3,433member
    I'd rather take medical advice from an AppleWatch than the FDA.
  • Reply 2 of 34
    Quote:

    Originally Posted by pmz View Post



    I'd rather take medical advice from an AppleWatch than the FDA.

    There is no law against stupidity.

     

    Knock yourself out.

  • Reply 3 of 34
    arlorarlor Posts: 490member
    Quote:

    Originally Posted by anantksundaram View Post

     

    There is no law against stupidity.

     

    Knock yourself out.


     

    Indeed.

     

    If any device is going to be monitoring something important, like insulin levels for example, I want the FDA all over it. 

  • Reply 4 of 34
    There is no law against stupidity.

    Yep. Especially in Internet comments.
  • Reply 5 of 34
    applezilla wrote: »
    There is no law against stupidity.

    Yep. Especially in Internet comments.

    Spot on.
  • Reply 6 of 34
    arlorarlor Posts: 490member
    Quote:
    Originally Posted by sog35 View Post

     

     

    fuk the FDA.

     

    They are run by the very drug companies they suppose to monitor. 

     

    Do you know how many people die from 'side effects' from drugs that were deemed safe by the FDA?  Tens of millions.  Throw enough money at the FDA and they will give your drug approval (say hello Phen Phen)

     

    These are the same bastards that allow POS toxins like Pink Slime to be served at McDonalds


     

    I don't think the FDA is without flaws (especially on the foods and "dietary supplements" side), but TENS OF MILLIONS? That would be a tremendous scandal.

     

    What drugs, precisely, do you have in mind that have caused (assuming you mean at least two tens of millions) about 8% of the current population of the US to die? 

     

    It can't be Fen-Phen, because the FDA *never approved* the use of those drugs in combination. They were approved separately, and it's doctors who decided to prescribe them together, off label. The FDA has no easy way to regulate off label uses of drugs. 

     

    Probably the deadliest drug ever approved by the FDA was Vioxx, but even that has only been linked to a few tens of thousands of deaths. 

     

    Like I said, they could do a lot more with food and a hell of a lot more with dietary supplements (which they can't meaningfully regulate under current laws), but the drugs issues aren't as bad as you say.

  • Reply 7 of 34
    john.bjohn.b Posts: 2,717member
    Quote:

    Originally Posted by AppleInsider View Post



    ...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.   Among the 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.

     

    So, as long as the manufacture tacks on the standard disclaimer:

     

    Quote:

     "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."


     

    They are good to go?

  • Reply 8 of 34
    So the FDA deems weight management 'general wellbeing', but obesity and eating disorders are unrelated and therefore need approval by the FDA?

    Seems to me, the FDA is in danger of disappearing up its own backside.

    No Apple Watch needed to diagnose that health risk.
  • Reply 9 of 34
    iqatedoiqatedo Posts: 1,595member
    Quote:
    Originally Posted by AppleInsider View Post



    Devices which make claims regarding the treatment or diagnosis of ... erectile dysfunction will not be considered in this category and will face FDA scrutiny.

    Just as well, although I'd love to know what my iWatch would have to say about that. Would any alarm be subtle enough?

  • Reply 10 of 34
    iqatedo wrote: »
    Devices which make claims regarding the treatment or diagnosis of ... erectile dysfunction will not be considered in this category and will face FDA scrutiny.
    Just as well, although I'd love to know what my iWatch would have to say about that.

    I'd think if the ?Watch drops off your penis as you're trying to get aroused you might have a problem getting erect. :p
  • Reply 11 of 34
    boredumbboredumb Posts: 1,414member
    Quote:

    Originally Posted by Benjamin Frost View Post



    So the FDA deems weight management 'general wellbeing' but obesity and eating disorders are unrelated and therefore need approval by the FDA?



    Seems to me, the FDA is in danger of disappearing up its own backside.



    No Apple Watch needed to diagnose that health risk.

    You might try reading with a bit more discernment...plenty of people DO have weight management issues,

    without it qualifying as a "disorder" or "condition".

    Further, when you think about it, "weight management" doesn't necessarily imply being overweight -

    it may simply imply a systematic attempt to avoid that result.

  • Reply 12 of 34
    iqatedoiqatedo Posts: 1,595member
    Quote:

    Originally Posted by SolipsismY View Post





    I'd think if the ?Watch drops your penis as you're trying to get aroused you might have a problem getting erect. image



    Of course, ?Watch, not iWatch - thank you Unfortunate mistake at just that juncture.

  • Reply 13 of 34
    MacProMacPro Posts: 18,155member
    pmz wrote: »
    I'd rather take medical advice from an AppleWatch than the FDA.

    My AAPL hopes there are many more that think like you, even if it was probably hopefully a joke. :)
  • Reply 14 of 34
    maestro64maestro64 Posts: 4,481member
    Quote:

    Originally Posted by Arlor View Post

     

     

    Indeed.

     

    If any device is going to be monitoring something important, like insulin levels for example, I want the FDA all over it.


    I guess you have not seen all those lawyer ads about all the FDA approved drugs which did harm to people. The most recent one was high blood pressure med, killing people due to unstopable internal bleeding. But then again these people who have high blood pressure were not long for the earth.

  • Reply 15 of 34
    boredumb wrote: »
    So the FDA deems weight management 'general wellbeing' but obesity and eating disorders are unrelated and therefore need approval by the FDA?


    Seems to me, the FDA is in danger of disappearing up its own backside.


    No Apple Watch needed to diagnose that health risk.
    You might try reading with a bit more discernment...plenty of people DO have weight management issues,
    without it qualifying as a "disorder" or "condition".
    Further, when you think about it, "weight management" doesn't necessarily imply being overweight -
    it may simply imply a systematic attempt to avoid that result.

    Last I heard, obesity was a weight management issue.
  • Reply 16 of 34
    pmzpmz Posts: 3,433member
    Quote:

    Originally Posted by digitalclips View Post





    My AAPL hopes there are many more that think like you, even if it was probably hopefully a joke. image

     

    Not really. The FDA is one of many government agencies that use a facade of public service to hide extremely illicit activity. They are run by a street gang of pharmaceutical companies that exist purely for profit, and not for human betterment. I wouldn't trust a single thing out of that agency if my life depended on it.

     

    So, I might as well use a gadget for medical advice, compared to the FDA.

  • Reply 17 of 34
    richlrichl Posts: 2,213member

    I'd hope that health trackers would give scientifically sound medical advice. I'm not sure that FDA regulation is needed but some kind of FDA-approved scheme would be beneficial to users. 

  • Reply 18 of 34
    pazuzupazuzu Posts: 1,728member
    pmz wrote: »
    I'd rather take medical advice from an AppleWatch than the FDA.

    I'd rather eat right and exercise regularly and do neither.
    These devices are for sloths or amateurs who wind up throwing them in a drawer anyways after 4 months.
  • Reply 19 of 34
    pazuzupazuzu Posts: 1,728member
    Last I heard, obesity was a weight management issue.

    Easily solved by eating less , exercising more and saving the $500.
  • Reply 20 of 34
    arlor wrote: »
    Indeed.

    If any device is going to be monitoring something important, like insulin levels for example, I want the FDA all over it. 

    The FDA doesn't do anything but keep drugs out of people's hands who actually need them, and keep drug prices high for big pharma. We don't need government regulation on stuff like this. All they'll do is regulate Apple and slow down product development. I'm fine with the FDA giving guidelines that people can CHOOSE to follow, but forcing people to follow them is not my thing nor should it be anyone else's. You big government types love to regulate and control people.
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