In late July 2011, the FDA released a draft guidance document outlining when certain types of software would be considered a “medical device” subject to FDA scrutiny. Though the guidance is ostensibly limited to “mobile medical apps,” reading between the lines makes clear that all software developers should pay close attention. Public comments on the draft guidance are due by October 19, 2011.

As with all products, the key issue of whether software – mobile or not – is a regulated medical device depends on whether it is intended to (1) diagnose disease or other conditions (e.g., pregnancy); (2) cure, mitigate, treat, or prevent disease; or (3) affect the structure or function of the human body. Intended use may be shown by labeling claims, advertising, website promotions, and even oral statements by the manufacturer or its representatives.

The FDA’s draft guidance lists four broad categories of intended uses of a mobile medical app that would make the software a medical device subject to regulation, as follows:

  1. display, store, or transmit patient-specific medical device data in its original format;
  2. control the intended use, function, modes, or energy source of another connected medical device;
  3. transform the mobile platform into a regulated device; or
  4. create alarms, recommendations, or new information by analyzing or interpreting medical device data from another device.

For more information – including the scope of applicable regulation, who is subject to regulation (and who is not), and examples of software apps that the FDA believes are not subject to regulation – please see our full article available here.