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AFAIK continuous glucose monitors are regulated by the FDA because of the microneedles: breaking the skin puts them under extra scrutiny. I don't think they nee
by andreareina 7y ago
AFAIK continuous glucose monitors are regulated by the FDA because of the microneedles: breaking the skin puts them under extra scrutiny. I don't think they need to be behind a prescription, but I 100% support regulation to at least ensure that the devices are safe and sterile.
- gumby 7y agoYou need FDA approval (510(k) or PMA) if you use the device to make an actual medical claim, regardless of whether it pierces the skin or not.
- andreareina 7y agoGood point. It might have been that a prescription is required because it pierces the skin; at any rate I remember some complication on getting a hold of them easily because of that.
- gumby 7y agoThey are medical devices that provide diagnostic information so they would require licensing regardless. The tongue depressor is a class 1 medical device. In the case of a CGM like Dexcom or attached meter like Freestyle Libre or a glucose meter that takes a drop of blood on a strip, or even glucose monitoring urine strips: all require FDA approval to be marketed as a diagnostic tool. They have to show a certain tolerance of accuracy and be manufactured under GMP. The FDA isn't messing around. I've been down this path with the FDA in a prior life so I'm not just speculating. (Also FWIW the extremely thin needles used in the mounted devices aren't referred to as "microneedles" -- that term is used for a different technology used in some drug delivery patches.)