The FDA's Risk-Based Approach To Medical App Enforcement

Law360, New York (September 21, 2015, 10:45 AM EDT) -- Diane Romza-Kutz

Fredric Roth As smartphones and tablets become more ubiquitous, the apps they run are beginning to follow suit. These apps are now used for practically everything, from controlling our TVs, the lighting in our homes, unlocking our cars and acting as a boarding pass at the airport. This pervasiveness has most recently reached our bodies, with an explosion of health apps available for both consumer and physician use. This new industry, however, quickly found itself in a situation where the regulatory landscape was confusing, if not daunting. Many app creators had never faced U.S. Food and Drug Administration regulation...

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