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back to article FDA draws line between wearable health gizmos and proper medical gear

The US Food and Drug Administration (FDA) has published draft rules for wearable gadget makers to follow if they want their stuff classified as "general wellness" devices by the watchdog. By "general wellness", the regulator means monitoring basic things like heart rates and distances walked each day, as opposed to vital …

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  1. Eddy Ito

    Of course, if you claim your wrist-puter or in-shoe gadget can cure cancer, or something like that, you'll need an FDA-approved classification reserved for medical devices, which need extensive testing and are much harder to obtain thanks to stricter regulations (as you'd expect.)

    There is also the possibility the buyer would also require a prescription depending on the devices actual functionality. Granted that's typically reserved only for items the FDA feels can be abused or when they feel safety is an issue if used improperly.

    1 0 Reply
  2. Robert Helpmann??
    Childcatcher

    Too much of a good thing

    I listened to several interviews with doctors concerning this subject. One of the more interesting points they made was that what these devices do very well is generate data, which really doesn't help the physician diagnose what ails their patients. The phrase "drowning in data" comes to mind.

    5 0 Reply
  3. The Nazz

    Mental wellbing?

    I would suggest that anyone who "needs" such a device to live a happy and healthy life style would probably fail the mental well being test.

    I do just fine in the great outdoors without any such gadget.

    8 1 Reply
  4. frank ly

    'Medical' advice too?

    Lazing in a chair at just past midnight with a heartrate of 80bpm? The display should say, "go to bed and get some sleep you idiot."

    0 0 Reply
  5. Roland6 Silver badge

    I'm a little surprised that the FDA aren't being encouraged to draw a line between consumer devices and medically approved devices. I'm sure the iWatch will be able to monitor my pulse, but will it's readings be accurate and reliable?

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