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FDA clarifies plans for mobile health regulation
Written by Anne DeGheest // 25 March 2013 // FDA

Brian Horowitz in eWeek wrote a very nice article on upcoming FDA regulation. PLease find key extracts below:

The U.S. Food and Drug Administration plans to regulate medical devices connected to smartphones, but consumer devices such as the iPhone and app stores like iTunes and Google Drive will remain clear of oversight, an FDA official told the House of Representatives' Subcommittee on Oversight and Investigations on March 21."

[The] FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended," Christy L. Foreman, director of the FDA's Office of Device Evaluation at the Center for Devices and Radiological Health, told the congressional panel."

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