FDA Issues Draft Guidance for Mobile Medical Apps

Jul 28, 2011   

On July 21, 2011, the U.S. Food and Drug Administration (FDA) issued its draft guidance describing the agencys plan to apply its regulatory oversight to certain types of mobile medical applications (“apps”) that run on mobile platforms. The agency is focusing on medical apps that directly diagnose or treat conditions such as diabetes or transform mobile platforms, such as smartphones and iPads, into medical devices.

Regulated medical apps are defined as software applications that meet the definition of a medical device pursuant to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and are either 1) used as an accessory to a regulated medical device, or 2) transform a mobile platform into a regulated medical device. For example, an app that would allow a health care professional to make a specific diagnosis by viewing a medical image from a picture on a smartphone would be considered an accessory. However, an app that turns a smartphone into an electrocardiogram machine would transform a mobile platform into a regulated medical device.

Medical apps, like other medical devices, will be classified as Class I, Class II, or Class III, and will be subject to the same requirements as the medical device classification. Some of these requirements include registering and listing the medical app with the FDA, premarket approval or clearance, labeling, quality system regulation, and medical device reporting. More information on FDA medical device regulation can be found here

The FDA is currently seeking public comment on how it should approach mobile medical apps that are accessories to other medical devices so safety and effectiveness can be reasonably assured. The deadline for submission is October 19, 2011.

Fuerst Ittleman will continue to monitor the progress of the FDAs regulation of mobile medical apps. For more information, please contact us at contact@fidjlaw.com.