Following is an excerpt:
It's an exciting time, but all of this change has made things tricky for the FDA, an agency that is more at home regulating blood pressure cuffs and stethoscopes than mobile software. Today, there are thousands of mobile medical apps, most written for the iPad or the iPhone. According to the FDA, only a handful of them are cleared for medical use.
"This is the wild west," says Thompson, an expert on FDA regulations. "The thing that is so hard for the FDA to grapple with is there are just so many apps out there."
Thompson advises clients on FDA regulations for a living. At present, his job is pretty tricky, whenever his client happens to be a mobile app maker. "I have all these companies coming to me wanting to do the right thing and I have to somehow advise them when I know full well the FDA isn't enforcing the rules."