I came across a review on the G5 in the app store that states that they feel that Dexcom is in violation of the app store software agreement 2.5.9 and they willl be reporting it. 2.5.9 states, “Apps that alter or disable the functions of standard switches, such as the Volume Up/Down and Ring/Silent switches, or other native user interface elements or behaviors will be rejected. For example, apps should not block links out to other apps or other features that users would expect to work a certain way.” I’ve thought about reporting it myself also. Thoughts? Have a wonderful day!
My guess is the FDA will be over-riding any concern that Apple has over the Dexcom function. I wish that wasn’t so, but in a medical gadget, changes in the alarms would almost certainly require FDA approval.
By all means put the request in, but any response will likely be slow to come.
It is confusing whether the FDA does or does not need to approve new apps from Dexcom as well as revisions to existing apps.
January 23, 2015
FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring
[blah blah blah]
“Because the device is low to moderate risk, the FDA has classified the device as class II exempt from premarket submissions. In the future, manufacturers wishing to market devices like the Dexcom Share system will not need premarket clearance by the FDA prior to marketing, but they will still need to register and list their device with the agency, as well as follow other applicable laws and regulations.”
[blah blah blah]
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm431385.htm
So that makes it sounds like only the FIRST time was FDA approval required.
But then on the Dexcom site more recently:
June 7, 2017 08:00 AM PDT
Dexcom Announces FDA Approval of G5 Mobile App for Android Devices
[blah blah blah]
“Dexcom is pleased to announce the Food and Drug Administration (FDA) approval of the Dexcom G5 mobile app for Android devices.”
[blah blah blah]
https://www.dexcom.com/dexcom-announces-fda-approval-of-g5-mobile-app-for-android-devices
I know it matters a great deal to those who use Medicare. Right now Medicare has ruled that those on Medicare cannot use the telephone for their Dexcom device. As the fight with Medicare continues little things like if the FDA has approved a current version will be so important it is almost unimaginable. It seems someone needs to step in and help Medicare understand the reality of use. Oh nevermind, what was I thinking when I wrote that?
@Rphil2 - I do not think whether the FDA has to approve apps or not has anything to do with the various aspects of the Medicare decision to cover the Dexcom G5 CGM system.
I understand sort of. But, it is also true that by and large Medicare is not paying for non-FDA certified items. For instance, Medicare will not pay for software to record blood sugar. They are not FDA approved.
My sense is that unless the app is FDA approved Medicare will always disqualify its use as a data collection device. Oh, do not get me started on the Apple watch.
Currently, one argument is if Dexcom will make transmitters for the Medicare only market, or worse yet if they will dumb down future devices to make them saleable to the Medicare market.
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