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FDA Outlines Oversight of Mobile Medical Applications

July 20, 2011

The U.S. Food and Drug Administration (FDA) is seeking input on its proposed oversight approach for certain mobile applications for medical and healthcare called mobile medical applications (apps) designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

Today, mobile medical apps, include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device.

According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a healthcare application by 2015, the FDA said.

“The use of mobile medical apps on smart phones 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 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The agency’s draft guidance defines a subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices.

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