FDA announces plans to regulate two broad categories of apps

September 23, 2013
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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

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