FDA Gives Final Guidance on Mobile Medical App Oversight

(HealthDay News) — The U.S. Food and Drug Administration issued final guidance for mobile application (app) developers, and is focusing its oversight on medical apps that will be used as accessories to regulated medical devices, or that transform a mobile device into a regulated medical device.

For the majority of mobile apps, which pose minimal risk for consumers, the FDA will exercise enforcement discretion. Regulatory oversight will be focused on a subset of medical apps that could pose greater risk to patients.

Oversight is being focused on mobile medical apps that are intended to be used as an accessory to a regulated medical device, such as an application that allows a health care professional to make a diagnosis by viewing a mobile image from a picture archiving and communication system, or apps that transform a mobile platform into a regulated medical device, such as an electrocardiography machine to detect abnormal heart rhythms.

“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,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”