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US FDA issues final rules on mobile medical apps

Reuters, September 24, 2013
(Reuters) - The U.S. Food and Drug Administration has issued final rules governing the development of mobile medical apps, saying it will focus its oversight on those products that have the potential to harm consumers if they do not function properly. The rules, announced on Monday, come more than two years after the FDA released draft guidance in which it proposed regulating any mobile app deemed to be a medical device. The FDA said it will only regulate products that transform smartphones into devices the agency currently regulates, such as electrocardiography (ECG) machines that can determine whether a patient is having a heart attack.