FDA regulation of mobile devices forthcoming

Regulation of medical apps may be closer than we think. Medical device consulting firm Emergo says that Dr. Jeffrey Shuren, the Food and Drug Administration's Center for Devices and Radiological Health director, confirmed at a town hall meeting held March 10 in Irving, Texas that guidance for such technology will be issued sometime in 2011. According to a blog post, software validation will be required, but it is not known if pre-market [510(k)] approval will be required or not. Post