Will Healthcare Apps Have to be Approved by the FDA?

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When you start to look at what the FTA is today, evolving guidance in the mole medical space. They've had guidance in medical devices since the beginning of time. And there was a clear distinction between a note to file a class-1 medical device, class-2 medical device etc. And all this is predicated in what is called intended use and if you intended use is to treat, mitigate or diagnose a disease, then you'll more than likely fall in a regulated space, could be class-1, could be class-2.

In the case of well doc and our Bluestar product we're taking data from a predicate class-2 medical device, in this case a [xx] glucose meter and we're interpreting it and analyzing that data and providing coaching back to the patient and so under the excessive rule of the FTA we qualify as a class-2 medical device.