FDA Issues Final Guidelines On Mobile Medical Apps

The development of mobile apps is rapidly growing with the top three stores (Apple’s App Store, Google Play, Windows Phone Store) reporting an increase in the number of downloads.  There are various apps that a person can download on their mobile device such as games, productivity apps, and then there are medical apps.


The U.S. Food and Drug Administration is concerned on the safety of people using mobile medical apps that it has issued final rules covering its development. The rules come two years after the initial draft was created where the agency proposed to regulate any mobile app that functioned as a medical device.

The final rules of the agency only seek to regulate products that transform a smartphone to a medical device that it currently regulates. An example is the electrocardiography (ECG) machine which can determine if a patient is having a heart attack. The rules also aim to regulate apps that act as an accessory to a medical device such as displaying images on the device screen.

The agency is focusing on medical apps that

  • Are intended to be used as an accessory to a regulated medical device – 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.
  • Transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

The FDA will not regulate the sale or use of mobile devices or mobile app distributors such as iTunes or Google Play.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly. Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”

The FDA has approved the use of around 100 mobile medical apps in the past ten years, 40 of which were approved in the past two years.

via fda