There are at least six pathways to legally using a medical device on a human in the US: HDE, IDE, PMA, 510(K), de novo, 510(k) exempt.
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This process usually follows a failed 510(k) application, and you can actually submit it concurrently to automatically trigger.
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This pathway is most applicable to IoT devices.
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6. 510(k) exemptions are granted to some low-risk Class 1 and Class 2 devices, e.g. toothbrushes, cotton swabs, etc. You self-certify.
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However, you still have to register the device and are beholden to FDA regulations. Most extant IoT devices (e.g. Quip) fit this pathway.
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But IoT-ing a 510(k) exempt device isn't going to break any new public health ground, so be wary of such claims.
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Finally, fitness trackers are not considered medical devices, but rather are general wellness devices, and so you cannot make medical claims
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So when a company comes out with some new IoT thing, e.g. below, this will help you decide of they're full of shit.https://twitter.com/Pinboard/status/790512148350992384 …
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Simply ask, "do they have the money to go down the right pathway?"
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