Experience with SaMD and iPhone store

We are submitting an application that collects data from other devices and presents it in a dashboard. Google accepted our app but iPhone seems to have serious regulatory review here. It’s only to be used in clinical trials as research use only but it’s not through an irb yet.

Apple is really digging into this asking which irb has approved it Thats premature and we won’t know that until we promote it in the field.

Anyone have experience navigating the Apple regulatory system for SaMD?

If you are calling it a SaMD, then Apple requires regulatory approval because you are calling it a medical device. If you call it a data collection device, then Apple may be more lenient.

Maybe…but where does the data come from? A measurement device for medical data is a diagnostic device even if it is not a definitive diagnostic device. Is the data coming from Apple’s already installed measurement apps? Or is this new app taking the measurements? That is a distinction that matters…

They approved us. I dug deeper and FDA considers Apple to be a distributor.