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FDA seeks public input on medical mobile app oversight project

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The FDA announced its proposed oversight approach for mobile medical applications designed for smartphones and other mobile computing devices. The agency is seeking input from the public on its draft guidance, which is designed to encourage the development of new apps without regulating the sale or general consumer use of smartphones or tablets.

Mobile medical apps currently cover a range of functions, such as helping maintain calorie intake, maintain a healthy weight and allowing physicians to view radiology images on mobile devices. According to the mobile research firm research2guidance, 500 million smartphone users worldwide will be using a health care application by 2015, FDA officials said in a press release.

“The use of mobile medical apps on smartphones and tablets is revolutionizing health care delivery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”

The agency’s draft guidance defines a small subset of mobile medical apps that affect or may affect the performance or functionality of currently regulated medical devices, according to the press release. This subset includes mobile medical apps that:

• Are used as an accessory to medical devices already regulated by the FDA (for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
• Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (for example, an application that turns a smartphone into an electrocardiogram machine to detect abnormal heart rhythms or determine whether a patient is experiencing a myocardial infarction).

Once the approach is posted, comments can be submitted for 90 days online or by writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The FDA will update the guidance based on feedback received.

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