FDA limits scope of final rule governing mobile medical apps

The FDA rolled out final rules to guide companies developing mobile medical apps, a good two years after issuing an initial draft measure.

They'll exert regulatory control over apps designed to work with a regulated medical device or turn a smartphone/tablet into a de facto medical device. For example, an app that would transform a smartphone into an electrocardiography (ECG) machine would be fair game. An app that would let a doctor diagnose a patient by way of an image-archiving system on a smartphone or mobile tablet would also draw the FDA's attention, regulators said.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, told Reuters that the FDA's new industry guidance focuses on an app's given function and risk.

"It's not about the platform. It's about the functionality. An ECG is an ECG," Shuren said.

In other words, the FDA will regulate a subset of apps that would jeopardize a patient's health if they don't work as intended. From now on, these kinds of apps are going to go through a regulatory process just like other medical devices do.

Here's the good news. The FDA declined to regulate most tablet or smartphone apps. Equally important, regulators will refrain from swooping in to govern the activities of mobile app distributors such as the iTunes store or Google Play. Also off the hook are pedometers, heart-rate monitors or other wellness devices.

The FDA said it dealt with more than 130 comments on the draft guidance it issued in July 2011. Over the past decade, regulators have cleared approximately 100 mobile medical apps, 40 of which came through in just the previous two years.

Regulators are also on a roll as far as getting some long-delayed medical device guidance up and running. Last week, the FDA issued its final rule for unique device IDs (UDI). Manufacturers of high-risk device technologies now have a year before they must start labeling their products for tracking.

- read the FDA announcement
- here's Reuters' take