• State Verified Answer
  • Replies 4 replies
  • Subscribers 3 subscribers
  • Views 206 views
  • Users 0 members are here
Options
Related

Getting Approval for ‘Medical App’

9747506

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!

  • +1

    Try to rebrand it as a note taker, upload as a new app, let it be approved, then edit the description and add a few example use cases, and there mention your use case amongst others

  • 0 in reply to flocsy🤠

    I had considered this; that’s all it *really* is, but because the app has a bunch of medications and medical procedures listed, I don’t think I could do that without scrapping all of that stuff and leaving behind almost nothing. I’d rather not do that.

    And then of course if I did scrap it just to add it back in, I imagine that would not necessarily go over well.

  • 0 in reply to 9747506

    I'm not affiliated with Garmin, just another hobby dev, but I don't think they do review the apps every time we upload a new version.

    I don't see how your app works or looks, but it sounds like there's some thematical menu in there. It would complicate it a bit but you could make that as a user providable thing. They could go to a website where they could pick the topic and then the app would download a json configuration for that topic. This way your app is kept general (you might be surprised what future uses other users will have) but it still gives the same solution as it does now, the medical part however is decoupled to the website.

    But if I were you I'd just try the 1st simple version, 2nd update with new features. If for some reason the update will be blocked you can still do the downloadable configurations later