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