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FDA Issues Final Guidance on Mobile Medical Apps

Tailored approach supports innovation while protecting consumer safety (September 23)

The FDA has issued final guidance for developers of mobile medical applications (apps), which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices.

The agency intends to focus its regulatory oversight on a subset of mobile medical apps that present a risk to patients if they do not work as intended.

“Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

The FDA is focusing its oversight on mobile 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; or
  • 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.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

The agency does not regulate the sale or general consumer use of smartphones or tablets, nor does it regulate mobile app distributors, such as the iTunes App store or the Google Play store.

The agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past 2 years.

Source: FDA; September 23, 2013.

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