It's been over two years since the U.S. Food and Drug Administration issued draft guidance on the regulation of mobile health apps. Now, the government agency has released its final guidelines.
On Monday, the F.D.A. said its oversight will apply to two broad categories of apps:
- Those intended to be used as “an accessory to a regulated medical device” – for example, an app that enables a healthcare provider to diagnose a condition by viewing a medical image from a picture archiving or communication system on a smartphone or tablet; or
- Apps that “transform a mobile platform into a regulated medical device” – for example, apps that turn smartphones into an electrocardiography (ECG) machine that can detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Apps that fall into these two categories will be evaluated using the same regulatory standards that the F.D.A. applies to other medical devices