A user recently had trouble installing OpenSeizureDetector because you need a computer to install the Garmin watch app, and she only has a phone. So I tried to get the OpenSeizureDetector watch app listed on the Garmin Connect App store to make installation easier. I received this polite refusal to list the app:
Dear Graham,
Thank you for submitting OpenSeizureDetector GarminSD Watch App to the Connect IQ store. After reviewing your submission, we have decided not to approve the app for the following reasons:
“Your app may be subject to regulation by the U.S. Food and Drug Administration (FDA) as a device, such that it needs clearance or approval by the agency before it can be lawfully marketed in the U.S. FDA has issued two guidance documents on the topic: (1) the Mobile Medical App Guidance, https://www.fda.gov/media/80958/download, and (2) the Clinical Decision Support Guidance, https://www.fda.gov/media/109618/download If you believe that your app is lawfully marketed, please re-submit your app to Garmin for approval, with your reasoning and/or appropriate documentation. Otherwise, you must update the app description to reflect that this app is not intended to be used for the purposes of medical treatment and is intended for educational purposes only.”
To access your app submission, make any necessary changes, and re-submit your app for approval, go to: https://apps.garmin.com/en-US/apps/69f90c8d-8545-40e7-8e9b-5b8acf91f4bb
Garmin’s terms of use and the Connect IQ Developer Agreement are available at the following links: https://www.garmin.com/en-US/legal/terms-of-use and https://developer.garmin.com/connect-iq/sdk/. Please contact ConnectIQAppAdmin@garmin.com if you have any questions.
I guess Garmin are worried about legal action if they publish something that should be FDA approved, but I don’t have the energy to try and work out whether OpenSeizureDetector would need FDA approval or not, so I am going to leave the installation as requiring a computer. If someone else would like to read the documents above and help draft a response explaining why it is ok to be published on the Garmin app store though, I’m happy to re-submit it.
Graham (graham@openseizuredetector.org.uk)