I feel it necessary to point out, though, that OS X is not a microkernel system comparable to Minix
While this is true, it's worth noting that a lot of the compartmentalisation and sandboxing ideas that most of the userland programs on OS X employ (either directly or via standard APIs) have roots in microkernel research. OS X is in the somewhat odd situation of having userspace processes that are a lot more like multiserver microkernels than its kernel...
With medical devices efficacy and safety are very closely linked. If you're providing a product that monitors blood glucose and you do a poor job of it, your customer makes incorrect medical decisions that are potentially life threatening. The closer an app gets to providing such "actionable" information, the more likely it is that it requires FDA approval.
That said, this "can't be overseen" thing is silly. The FDA doesn't have the resources to oversee ALL smartphone health apps, they don't want to, and they shouldn't. There's no debate there. If the next generation of phones include electrocardiogram electrodes or a sophisticated spectrometer, the FDA is going to regulate the health software using those tools. That's really the news coming out of that FDA statement.
Software production is assumed to be a line function, but it is run like a staff function. -- Paul Licker