Hi All,
I built an app meant to be used by medical staff (such as myself). It’s relatively simple and basically functions as a note pad / watch / timer.
When I submitted the app, I found out about the difficulty getting ‘medical apps’ approved for the IQ store. I can absolutely understand that, as many may require FDA oversight.
However, my app very clearly falls into the ‘Not a medical device’ based on several factors that are listed on the FDA website. I tried changing my listing to match those factors, but it still is considered not approvable apparently without FDA approval?
Getting FDA approval for a non-medical device seems… overkill? Not to mention certain aspects could be costly.
I’m wondering if anyone has experience with this, or if there is anyone specific from Garmin who I could speak with about this, given the clear direction from the FDA that my app does not qualify as a ‘medical device’ and would not require regulatory oversight or approval.
Thank you!
