1. A Humanitarian Device Exemption is granted to devices intended to diagnose/treat conditions with an incidence of < 4k cases/year.
-
-
This pathway is most applicable to IoT devices.
-
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.
-
However, you still have to register the device and are beholden to FDA regulations. Most extant IoT devices (e.g. Quip) fit this pathway.
-
But IoT-ing a 510(k) exempt device isn't going to break any new public health ground, so be wary of such claims.
-
Finally, fitness trackers are not considered medical devices, but rather are general wellness devices, and so you cannot make medical claims
-
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 …
-
Simply ask, "do they have the money to go down the right pathway?"
- 1 more reply
New conversation -
Loading seems to be taking a while.
Twitter may be over capacity or experiencing a momentary hiccup. Try again or visit Twitter Status for more information.