FDA Signals It Will Regulate Medical Apps

Pamela Lewis Dolan | amednews.com | May 30, 2011

As more medical mobile applications get developed, one thorny question has arisen: Is there anyone who should be verifying whether these apps are effective and safe?

The question has come up, in particular, because of apps that claim to have a clinical component. They're a small part of the app universe, but experts expect clinical apps to hit the market in a big way over the next few years.

As it turns out, someone is already beginning to answer that question. A handful of developers has sought and received Food and Drug Administration clearance for their mobile apps considered to be clinical devices. And the FDA, which hasn't involved itself in regulating or enforcing any rules that might be related to clinical app development, has indicated that it will be more proactive in monitoring that class of product...