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FDA drafts mobile medical app regulations
by Anne DeGheest
22 July 2011


Check Brian Dolan thorough review of the new FDA draft for mobile medical applications

"As part of its draft guidance the FDA, of course, had to sketch out its very particular definition of a mobile medical app. The agency broke the definition into three parts: mobile platform, mobile app, and mobile medical application. A mobile platform is a commercial off-the-shelf computing platform “with or without wireless connectivity” that is handheld. Mobile apps are software that can be run on a mobile platform or a Web-based software application that is designed for the mobile platform.   Finally, a mobile medical app is one that meets the definition of "device" according to the FD&C Act, but for this set of draft regulation it also must be "used as an accessory to a regulated medical device" or it must "transform a mobile platform into a regulated medical device."


 Apps that would not be regulated and Apps that would be regulated



tagsTopics: HealthTech Capital, Entrepreneur



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