FDA Drafts Regulations for Use of Mobile Medical Apps


The FDA encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or use of smartphones or tablets.

Today, mobile medical applications perfrorm a variety of functions ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view patients’ radiology images on their mobile communications device. These are the types of medical applications that have the U.S. Food and Drug Administration (FDA) seeking input on its proposed oversight approach for new types of medical applications.

The approach by the FDA 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. Over 500 million smartphone users worldwide will be using at least one health care application by 2015, according to Research2Guidance 2010.

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices.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 mobile medical apps that: A) are used as an accessory to medical devices already regulated by the FDA; or B) transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices. An example of the first subset guideline would be an application allowing 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 mobile tablet. An example for the second subset is an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or to determine if a patient is experiencing a heart attack.

Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, stated that “the use of mobile medical apps on smartphones and tablets is revolutionizing health care delivery.” Shuren added that the 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 FDA is seeking public input on this approach. Once posted, comments can be submitted for 90 days online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The FDA will update the guidance based on feedback received.

Around the Web

FDA NEWS RELEASE: FDA outlines oversight of mobile medical applications [U.S. Food and Drug Administration]

Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications [U.S. Food and Drug Administration]

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