FDA’s final guidance for mobile medical apps

The two broad categories of apps that the FDA regulates, according to the final guidance, are:

1. are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
2. transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

• The FDA also published an important guidance document for mobile health devicemakers — the hardware side of the industry — in August. The guidance on device interoperability had been in the works even longer than the mobile medical apps document.
  
  Read the FDA’s final guidance for mobile medical apps here. (PDF)