4. 510(k)s are premarket notifications, mostly for Class 2, but some Class 1 and 3 devices. It's a de facto clearance these days.
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Replying to @EmilyGorcenski
510(k)s require you to compare your device to an existing substantially-equivalent predicate, can be expensive, and you have to provide data
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Replying to @EmilyGorcenski
5. de novo pathways are for truly new medical devices that don't have an existing counrerpart on the market.
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Replying to @EmilyGorcenski
This process usually follows a failed 510(k) application, and you can actually submit it concurrently to automatically trigger.
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Replying to @EmilyGorcenski
This pathway is most applicable to IoT devices.
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Replying to @EmilyGorcenski
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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Replying to @EmilyGorcenski
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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Replying to @EmilyGorcenski
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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Replying to @EmilyGorcenski
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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Replying to @EmilyGorcenski
Extremily GorCIAnski Retweeted Pinboard
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 …
Extremily GorCIAnski added,
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thank you for this tweetstorm! Even though it’s a bit against Twitter etiquette to provide facts and useful information
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