The FDA Pivots to Regulate Apps?

In a move that will surely send waves through the health care and medical device communities, it has been reported that the FDA's Center for Devices and Radiological Health plans to issue guidelines on mobile medical applications later this year.

If the FDA indeed moves in this direction, the move raises a myriad of questions about when an app steps within the realm of the FDA. As noted by those who watch the otherwise deliberate and methodical FDA try to adapt to rapidly changing technologies, the potential impacts and challenges are staggering. Moreover, even once the FDA guidelines are issued, questions will remain about what falls within FDA purview and how will the FDA regulate it?

Perhaps there is an app for that...?