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Good 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 e
by andreareina 7y ago
Good 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.)