Mobile Apps: FDA Publishes Its Final Guidance on Regulating Mobile Medical Apps

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Explore:  FDA mHealth Mobile Apps

On September 25, 2013, the FDA announced publication of its final guidance for mobile medical apps. It’s a much awaited move on the part of the FDA. In my earlier blog post, I discussed the pressure on the FDA from Congress to finalize its regulatory policy for mobile medical apps. During the Congressional hearings in May of this year, the FDA declared it would finalize its policy by the end of 2013. We have evaluated the new guidance and compared it to its earlier version of 2011. Admitting that it is difficult to have one guidance to address all kinds of regulatory issues relating to mobile apps, the FDA has divided all medical mobile apps into three categories for regulatory purpose:

  1. Apps that are NOT medical devices
  2. Apps for which FDA intends to exercise enforcement discretion
  3. Apps that are focus of the FDA’s regulatory oversight.

Several examples are provided in these distinct categories to give an idea about what kind of functionalities the FDA is aiming to regulate in mobile apps. The final guidance further reflects upon the operations that turn an app developer into a regulated entity and touches upon scenarios that weren’t addressed in the earlier policy discussions by the FDA. For example, the FDA clarifies that:

  • A developer of a mobile app who is only responsible for performing design and development activities to transform the author’s specifications into a mobile medical app would not constitute a manufacturer.
  • A developer who creates a mobile medical app and hardware attachments for a mobile platform that are intended to be used as a medical device is considered a manufacturer.
  • A developer who creates a mobile medical app or a software system that provides users access to the medical device function through a website subscription, software as a service, or other similar means is considered a manufacturer.
  • Providers of tools, services, or infrastructure used in the development, distribution, or use of a mobile medical app are not considered as manufacturers of a medical app.
  • Licensed practitioners who manufacture a mobile medical app or alter a mobile medical app solely for use in their professional practice and do not label or promote their mobile medical apps to be generally used by others are not considered as manufacturers.
  • Persons who manufacture mobile medical apps solely for use in research, teaching, or analysis are not considered as manufactures.

Stay tuned for our further discussions as we continue to analyze and apply the new guidance.