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FDA Issues Draft Guidance on Mobile Medical Phone Apps

Daniel Low (Wiley-Blackwell)


The U.S. Food and Drug Administration today issued a draft of guidance to industry on oversight of mobile medical applications (apps) designed for smartphones and other mobile computing devices. Interested parties have 90 days to comment on the proposed regulations.

The industry market analysts Research2Guidance expect as many as 500 million smartphone users worldwide will use a health care application by 2015. FDA says it want to encourage development of new apps, thus the guidance focuses only on a subset of applications and will not regulate the sale or general consumer use of smartphones or tablets.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, says the proposed oversight will be limited to “only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.” The apps of concern to FDA are those that may affect the performance or functionality of currently regulated medical devices.

Among the apps covered by the proposed regulations are those that …

Act as an accessory to medical device already regulated by the FDA, or

Transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices

An example of the first case is an app that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet. An app that turns a smartphone into a device to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack would be an example of the second case.

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3 comments to FDA Issues Draft Guidance on Mobile Medical Phone Apps