In a former life, I designed medical devices. So by way of Tweetstorm, here's Emily's Guide to Knowing if IoT Wearable is Full of Shit.
-
-
Tech companies who seek an IDE are serious, but the low-risk exemption most often applies.
-
3. Pre-Market Approvals are highly-expensive equivalents to drug approvals, and are only requires for Class 3 and some Class 2 devices.
-
PMAs cost millions of dollars and require extensive clinical study, so this isn't going to be techbro startup shit. This is serious stuff.
-
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.
-
510(k)s require you to compare your device to an existing substantially-equivalent predicate, can be expensive, and you have to provide data
-
5. de novo pathways are for truly new medical devices that don't have an existing counrerpart on the market.
-
This process usually follows a failed 510(k) application, and you can actually submit it concurrently to automatically trigger.
-
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.