FDA to Focus on Apps That Turn Smartphones Into Medical Devices

A MIM Software app that allows doctors to view X-rays
and MRIs on smartphones and tablets was one of
the first to win FDA approval. (MIM Software photo / September 23, 2013)

As reported by Reuters: The Food and Drug Administration said Monday that it will focus on mobile medical apps that have the potential to harm consumers if they do not function properly.

The FDA, which issued final rules on the apps Monday, has cleared about 100 over the past decade, including products that can diagnose abnormal heart rhythms or help patients monitor their blood sugar. About 40 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 enforcement on products that transform smartphones into devices the agency currently regulates, such as electrocardiography 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.