The U.S. Food and Drug Administration (FDA) announced on Sept. 23 that it is expanding the scope of medical devices it regulates to include some mobile apps.
The FDA will now regulate mobile health-care apps in two broad categories — apps that act as an accessory or extension of an existing medical device, such as a program the enables a doctor to view medical images on a mobile device; and apps that turn mobile devices into a medical device, such as an app that enables a smartphone to be used as an electrocardiography (ECG) machine.
Regulation will only extend to those apps that serve similar or adjacent functionality to existing, traditional medical devices. These apps will be required to meet the same standards as those applied to existing medical devices. Apps that go along with medical devices that were already subject to FDA approval are largely unaffected.
The announcement comes two years after the FDA first issued draft guidance on the topic in 2011. The FDA received about 130 comments on its draft guidance and the organization reported “overwhelming” support for their stance in the recent announcement.
“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 Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
David Van Sickle, co-founder and CEO of Propeller Health, a company that makes a smart asthma inhaler, said the FDA’s announcement adds credibility to what medical device companies are doing and also places extra public attention on the important work they do.
The companies most affected by this update to the FDA’s regulations are those that develop applications that don’t have a physical device and therefore were not previously governed by the FDA. One example is cardiio, an iPhone heart rate monitor app.
The FDA announcement won’t really affect Van Sickle’s company, but he supports the tact the FDA is taking because they’re promoting good software development.
“Whether you’re in a regulated space or not, I think there are a set of practices that are overlapped with what’s being required by regulation that basically provide you with a set of standards and behavior in building software and tools,” Van Sickle said. “On the whole, I think it results in better end products.”