The U.S. Food and Drug Administration (FDA) this week issued guidance on mobile medical apps, a group of increasingly popular mobile applications that take the place of more traditional medical devices. The agency will “exercise enforcement discretion” in its regulation, ignoring the vast majority of medical apps that pose little risk.
The FDA will, however, heavily regulate a small number of medical apps that it sees as being high-risk for patients. These apps, if they fail to work, could pose health risks to consumers. In particular, the FDA will provide oversight of apps that function as “an accessory to a regulated medical device” or apps that perform the functions of regulated medical devices.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA. “The FDA’s tailored policy protects patients while encouraging innovation.”
As smartphone technology progresses, the capabilities of the devices have enabled hundreds of uses for medical practice. For example, the FDA states that apps now exist to detect abnormal heartbeats, use mobile devices as ultrasound machines, track glucose levels for diabetics, and operate mobile devices as electrocardiography (ECG) machines. The FDA will regulate such apps using the same standards it applies to stand-alone medical devices. The agency stated it has already approved around 100 mobile medical apps for use in the U.S.
“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,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”