4 ms·
Well, you are describing the maximally absurd end of that spectrum to make your point, but in the US the FDA does indeed ban all kinds of stuff to prevent both
by veidr 3y ago
Well, you are describing the maximally absurd end of that spectrum to make your point, but in the US the FDA does indeed ban all kinds of stuff to prevent both its sale, and use (i.e. to stop "the stupid" from using it).
Blood glucose monitors are sold without a prescription in many countries, and you can buy them with varying degrees of accuracy and use them for whatever you want; not in the US, though, because they are regulated as medical devices.
The same is true for lots of other stuff that could be used in non-medical or less-dangerous medical contexts, like nebulizers.
You can make a reasonable argument for your position, regarding this specific device or more generally. But the FDA has consistently rejected it.
- jprival 3y agoWorth noting that glucose meters are OTC. Continuous monitoring solutions generally seem to require a prescription, though there are telehealth companies that will help you sort that out. According to the article what the FDA really objects to is “non-invasive” glucose monitoring devices of any sort, on the grounds of general lack of evidence of accuracy.
- veidr 3y agoYeah, noteworthy point. Also, I think the article is weirdly sensationalized — the FDA isn't "against" anything here. If you click through to the FDA's bulletin[1], it's merely stating for clarity and public awareness that there are currently no non-invasive CGM devices that actually meet existing standards for accuracy. If somebody did produce one, it could be validated and approved via the same processes used by all the existing CGM products which have been approved. [1]: https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication https://www.fda.gov/medical-devices/safety-communications/do...