I don’t know what the FDA’s definition of medical grade. I would define that as laboratory tests, if so that may mean meters and CGMs will not come under FDA regulations and scrutiny.
"The only stipulation is if they make claims of something being medical grade, like a clinically appropriate, clinical grade blood pressure measurement. We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter," he added.
Of course we used meters and sensors to determine insulin boluses and whether to consume carbs to correct a hypo. But these devices are not exactly medical grade quality.
It’s not a loophole for most of us because the actual cost for those of us in the US with insurance, after the insurance, is less than the OTC cost of the “non medical” (but exactly the same I suspect) Dexcom and Abbott sensors.
However if someone were to import the sports-medicine devices it might be possible to do so for less than the Dexcom/Abbott US price despite the 25% tax.
Personal import also seems to be a possibility; it isn’t a prescription medication (it wasn’t even clear if CGM sensors were in the first place) so it is apparently legal to import it. Not Amazon these days; Bezos is sucking at the teat. That still hits the 25% tax, but it clearly might be well worth it.
I wasn’t clear, the loopholes is for the Dexcom and Libre that they don’t have to go through the rigors of FDA testing and approval. They can just put their stuff out, take it or leave it. It ust depends upon the FDA’s definition of Medical grade.
Are you talking about the iCGM/iPump stuff that Tidepool have been pushing for years? The previous arrangement required that every AIDS system that got FDA approval required approval of itself, specific to the pump and the CGM. The change is that pumps and CGMs can be independently certified as iCGMs or iPumps (the latter was Tidepools preference but the actual name is something unmemorable.) The iCGMs and iPumps can be fitted together like lego bricks and still meet FDA approval.
Apple want to be able to do BG readings (I think the above was Android) and Apple don’t want to be regulated.
If Dexcom and Abbott weren’t allowed to compete in that market it would be filled with devices that give bogus measurements. Of course it isn’t clear what “wearable devices”, apparently but probably not a quote from Malarkey, means; the Murdoch News link went to a web page of ads presumably selling devices from manufacturers who contribute to Rupies pension/yacht/enormous airplane.
It would be nice if Dexcom/Abbott’s price per sensor (currently $50) came down to match the price of that Smartwatch; it cost me $31.94 including shipping but lasted somewhat longer than either the Decom or Abbott sensors (about 30 days IRC.)
