2 ms·
OK fair, I misremembered exactly what happened. I'm still not convinced a contact tracing app would be legal though, given that it could lead people to seek me
by Alex3917 7y ago
OK fair, I misremembered exactly what happened.
I'm still not convinced a contact tracing app would be legal though, given that it could lead people to seek medical attention who might not otherwise need or benefit from it. Didn't Apple talk about how they needed to work with the FDA to get their ECG functionality approved?
- ceejayoz 7y agoAn ECG is obviously a medical device. A contact tracing app is far less obviously in that category. It might be, but it might fall under various exemptions, with the right disclaimers. https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-mobile-apps-are-not-medical-devices https://www.fda.gov/medical-devices/device-software-function... https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications https://www.fda.gov/regulatory-information/search-fda-guidan... > Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices. Some software functions may meet the definition of a medical device, but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act).