As the Food and Drug Administration considers regulation of "mobile medical applications," the American Medical Informatics Association is making available a presentation it gave to the agency on how it should approach oversight of mobile clinical decision support systems.
A mobile medical application, according to the FDA draft guidance issued for comment in July, "is a mobile app that meets the definition of 'device' in section 201(h) of the Federal Food, Drug and Cosmetic Act and either is used as an accessory to a regulated medical device or transforms a mobile platform into a regulated device."
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