As Apple Watch looms, U.S. FDA clarifies regulatory stance on health-tracking wearables

“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,” Sam Oliver reports for 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,” Oliver reports. “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.”

Oliver reports, “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.'”

Read more in the full article here.

[Thanks to MacDailyNews Readers “Fred Mertz” and “Dan K.” for the heads up.]

11 Comments

        1. And, if everyone would work together to make it better rather than repeatedly attempting to repeal or defund it based on political lines, it would be better. Even the name was concocted to ‘label and destroy’ the healthcare initiative. In fact, it would have been better from the outset if everyone in Congress had participated in the legislative effort in a positive way rather than inserting poison pill provisions in an attempt to prevent it from passing.

          Failing to address known problems (healthcare, immigration, etc.) or, worse, denying that such problems even exist, is an affront to U.S. citizens and an abrogation of their oaths of office and the U.S. Constitution.

          1. We tried to sign up for Obama-No-Care when it first took effect. The web site wouldn’t let us register (just kept looping back to the Enter Your Information page), and the numbskulls running it said if we didn’t register we couldn’t sign up for health insurance. After we finally did get insurance through it, they lost our direct electronic funds transfer premiums TWICE. Both times they canceled our insurance and wouldn’t let us get it back till the following month. So we’ve had 2 and 3 week periods with no health insurance due to THEIR messed up computer systems. I’m out of medicines and can’t get any till the first of next month unless I pay full price with NO chance for reimbursement.

            Yes, the health [no]care initiative definitely needs to be made better, or made to go away. Obama-No-Care: shafting the American public daily.

        2. you, not so much reasonable

          No patience, no reason, just premature unmitigated bashing

          took centuries for our present healthcare mess to evolve, and the re-DUH-publicans (who are wholly in the pockets of big money) so severely crippled Obamacare that it’ll take possibly centuries to get out of the mess we’ve created over this time. But look carefully at the facts, ignoring the fat cats, already things are getting better if you look, but you don’t because you are myopic. You are a sheep of the rich right wing, the bought and sold for. Sad you are so lonely you spend all your time on this site, let alone on a single track of comment. Please get a life. I mean PEROID!!! we could use a lot less of you,,, oh wait,,,, how about NONE!
          ,
          Oops, sorry i just fed the troll………..

  1. Food supplements are already well regulated. Thankfully they are still relatively freely available in the US, unlike many other countries where they are either completely restricted or require a prescription, often at clinically useless doses with their cost in turn becoming exorbitant. The well regulated but relatively free availability of food supplements without prescription are an important instrument in lowering the cost and increasing the efficacy of health care.

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