FDA Issues Final Rules Governing Mobile Medical Apps

The U.S. Food and Drug Administration issued final rules covering the development of mobile medical apps on Monday, saying it will focus it oversight on those apps that have the potential to harm consumers if they do not function properly.

The FDA has cleared about 100 mobile medical apps over the past decade, including products that can diagnose abnormal heart rhythms or help patients monitor their blood sugar. About 40 apps were cleared within the past two years.

The agency said it will not regulate the sale or general consumer use of smartphones or tablets or mobile app distributors such as the iTunes store or Google Play store.

It will, however, focus its enforcement on products that transform smartphones into devices the agency currently regulates, such as electrocardiography (ECG) machines that can determine whether a patient is having a heart attack.

The FDA will also focus on apps that would be used as an accessory to a regulated device, such as one that displays images used by physicians to make specific diagnoses.

(Reporting by Toni Clarke in Washington; Editing by Leslie Gevirtz)