FDA Review of Some Medical Apps May Be Increased

The iPhone/iPad and, to a lesser extent, Android health app category is a big one ranging from calorie counters to professional tools for radiologists. Its that high end of the category that has attracted the attention of the U.S. Food and Drug Administration (FDA) according to Reuters.

FDA plans oversight of some mobile medical apps

But, don’t worry! The proposed FDA oversight of health apps should not affect the vast majority of health related apps. Reuters reports that the FDA’s focus is on two specific categories of apps:

1. Apps that serve as an accessory to an FDA-regulated device
2. Apps that turn a mobile platform into a medical device.

The FDA has already become involved in approving some medical related apps. I reported on one in February of this year.

Mobile MIM for iPhone & iPad Approved by U.S. FDA: Remote Diagnostic Medical Imaging Tool

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