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jvv6 replied to the topic Mobile Medical Applications in the forum Introduction to Project Management 8 years, 2 months ago
I agree and believe your senior project would be classified as a “mobile medical app.” As you stated, the FDA did claim that “mobile medical apps” are intended to be “used as an accessory to a regulated medical device. Your app seems to do just that. Hearing aides are indeed FDA regulated medical devices and your app is being used in conjunction with that device.
There are probably a lot of examples you can find on the App/Play Store for mobile medical devices. I think I have an example of what might NOT be a a mobile medical device but could easily be mistaken as one. I have a friend whose senior project was to develop an app that is connected to a a heart-rate wrist wear such as a FitBit. The point of the App was to connect with friends or family and then you’d be able to monitor each other’s heart rate. You’d be notified through the app if someone’s heart rate would be too high just in case there was an emergency. Who knows, maybe your friend or family member could have a heart attack and is in a situation where he/she may not be able to get help.
Why I think this concept might not be a mobile medical app is because devices such as the FitBit itself isn’t regulated by the FDA in the first place. So in my opinion, the main takeaway would be that in order for an app to be a “mobile medical app,” the device that it’s supporting should be a regulated FDA medical device.
