Final Guidance on Medical Apps

In July 2011, FDA issued a draft guidance on Medical Apps that set out the agency’s approach to regulate apps – even as thousands of such apps were being developed and downloaded by users.  Just over two years later in September of 2013 – after collecting and analyzing input, FDA released a final guidance regarding its approach to regulating medical apps.

Apps in support of patients are serving an increasingly important role and are a means by which medical product manufacturers can support patients as well as providers.  Apps are a way to provide personalized support that is also portable.  But the span of function that exists with apps is quite broad.  Identifying which categories apps get what kind of regulatory attention more specifically appears to be a way in which the final guidance differs from the draft guidance.

In the final guidance, FDA has created three primary categories:

  1. Apps that are not medical devices – essentially apps that are informational or educational, but which are not used in making a diagnosis or medical determination  – FDA has created an explanation and provided examples in Appendix A of the Guidance;
  2. Apps that are medical devices but over which FDA is going to exercise enforcement discretion – think of these as apps that go beyond information or education, but interact with the patient in a way to help them manage their condition.  An example from the Appendix might be the use of GPS to warn a patient about asthmatic conditions in the area in which they are currently located.  Here the agency says that it MAY exercise authority – but the key here appears to be the level of risk that the use of the app might pose to the patient if the app were faulty.  You can find examples in Appendix B of the Guidance or on this handy page put up by the agency.   
  3. Apps that are medical devices over which FDA is going to exercise regulatory authority – these are those apps which are actually performing a medical function to diagnose and/or treat a patient – for example an app that might have a sensor or ability to interact that would allow the patient or provider to assess a condition.  You can find examples in Appendix C of the Guidance summarized on this page.

FDA has also provided a nice Q&A page and overview of medical apps. for those working in communications with manufacturers where apps may be a part of the plan, these three sections are key guides.

Those are the key differences for us communications folks, though there are some other new elements to explore for those interested such as provision for licensed providers who make their own app – and other technical legal aspects.  For those of us working in communications with manufacturers where apps may be part of a plan, the three sections above are key.

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