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.