The Food and Drug Administration will regulate mobile...
The Food and Drug Administration will regulate mobile applications that are used as an accessory to an already-regulated medical device, and apps that transform a mobile device into an already-regulated device, it said Monday in final guidance for mobile app…
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developers (http://1.usa.gov/16Fe2rE). Apps that for example let healthcare providers diagnose a condition by viewing a medical image from a smartphone will be regulated, it said, as will apps that turn smartphones into electrocardiography machines. Apps that diagnose abnormal heart rhythms or show ultrasound images are on the market. The FDA won’t regulate the sale of mobile devices, nor will it regulate app distributors like the Apple App Store or Google Play Store, it said. “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.” Republicans on the House Communications Subcommittee in March criticized the FDA proposal to regulate medical apps, though Democrats said the scrutiny was justified (CD March 20 p1).