FDA mulls regulatory oversight of mobile medical apps

The U.S. Food and Drug Administration (FDA) is seeking input on a proposal to provide oversight of certain mobile applications specific to medicine or healthcare 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, the agency noted.

"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," stated Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in a press release. "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The agency's draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes the following:

  • Mobile medical apps that are used as an accessory to medical device already regulated by the FDA. For example, an application that allows a healthcare professional to make a specific diagnosis by viewing a medical image from PACS on a smartphone or a mobile tablet.

  • Apps that 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 ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

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