FDA Publishes Final Guidance on Mobile Medical Applications

The FDA has finalized a draft guidance originally published in July 2011 regarding mobile medical applications.

This guidance details FDA’s approach to three categories of applications:

  • FDA does not regulate mobile apps that fall outside the Federal Food, Drug, and Cosmetic Act’s definition of a medical device.
  • FDA intends to exercise enforcement discretion over mobile apps that meet the Act’s medical device definition but pose a lower risk to the public.
  • FDA will apply its regulatory oversight to “mobile medical apps,” mobile apps that meet the Act’s medical device definition and are either:
    o   intended to be used as an accessory to a regulated medical device, or
    o   intended to transform a mobile platform into a regulated medical device.

FDA aims to focus its regulatory oversight on apps that could pose a risk to patient safety if the app does not function as intended.  The guidance includes appendices providing examples of mobile apps that fall within the three categories described above. 

The guidance is available online at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf     

Please contact Sterling if you would like to discuss how this guidance impacts your submissions for IRB review.

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