Risky Business Of FDA Mobile Medical Apps

Law360, New York (October 31, 2013, 5:45 PM EDT) -- The U.S. Food and Drug Administration has issued final guidance[1] on mobile medical applications, which are mobile apps that meet the definition of a device[2] and are intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device. Mobile apps are software applications that are run through mobile platforms (e.g., smartphones, tablet computers and other handheld computing platforms) or certain web-based software applications.

The final guidance states that the FDA will apply its regulatory authority...
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