Hi Ed
The US FDA explicitly excludes app stores from manufacturer requirements.
https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications#e
The EU rules also seem to apply to the device manufacturer and not the app store. Possibly they might want to check you're handling requirements like ensuring a communication channel from manufacturer to user in case safety notices may be needed at some point, and ensuring there's a declaration of conformity per 2017/745 article 6...
https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf
I could imagine Google and Apple doing a little bit of due diligence, like asking for a statement that the device meets registration and listing requirements, if it's actually a medical device. Amazon received another warning letter recently for distributing unapproved drugs, and I expect the app stores would like to avoid similarly being platforms for dangerous unapproved SaMD. But it's hard to imagine them having sufficient medical device expertise to delve very far into the details.
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Anne LeBlanc
United States
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Original Message:
Sent: 19-Dec-2023 10:16
From: Ed Panek
Subject: Regulatory Controls over Apple Store and Google Store
Does FDA or other regulatory bodies have any controls/oversight/reporting requirements for the Cell Phone application stores and if so what is the regulation number?
Submitting a non-medical software application per FDA 2019 guidance on dashboards and Google accepted quickly. Conversely, Apple is on our 8th round of queries.
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
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