FDA Gives Guidance for Mobile Medical Apps

The U.S. Food and Drug Administration last week issued final guidance for how it will regulate mobile medical applications, which it defines as software that runs on mobile devices and performs the same functions as traditional medical devices.

Some of these systems are designed to help consumers manage their health and wellness, but others are geared to help physicians diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings.

The agency indicated in the guidance that it would offer its enforcement discretion on the majority of such systems, as they pose minimal risk to consumers. It instead intends to focus its regulation on a small subset of mobile medical applications that could present a greater risk to patients if they don’t work as intended.

More specifically, the FDA will focus its oversight on mobile medical applications that are intended to be used as an accessory to a regulated medical device, such as software that enables physicians to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a tablet or smart phone. It also will focus on software that is designed to transform a mobile platform into a regulated medical device, such as an application that turns a smart phone into an ECG machine.

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

Mobile medical applications that are subject to FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices, according to the guidance. The FDA received more than 130 comments on a draft of the guidance, which was issued in July 2011. Respondents supported the agency’s ultimate decision of a tailored risk-based approach to its regulation of mobile medical applications.

The FDA has cleared about 100 mobile medical applications over the past 10 years; 40 of those were cleared in the past two years.

“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,” Shuren said. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”