FDA Final Guidance on Mobile Medical Apps

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Mobile Medical Applications

The number of mobile applications and users are growing every day.  Included in this expanding technology is the category of mobile medical applications. “Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.” (FDA) The technology for these apps is growing quickly and the FDA wants to ensure that proper safety measures are in place and followed to protect the public.  On September 25, 2013 the FDA released its final guidance for mobile medical applications.

Mobile Medical App Regulation

The FDA is using discretion when choosing which of these apps need review.  Many of the mobile medical apps will not be regulated by the FDA.  The FDA will not regulate mobile apps that do not qualify as a medical device or apps that are considered a low risk medical device. The FDA intends to show discretion for mobile medical apps which:

  • “Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
  • Provide patients with simple tools to organize and track their health information;
  • Provide easy access to information related to patients’ health conditions or treatments;
  • Help patients document, show, or communicate potential medical conditions to health care providers;
  • Automate simple tasks for health care providers; or
  • Enable patients or providers to interact with Personal Health Record or Electronic Health Record systems.”

Instead, the FDA will be regulating apps that meet their definition of a medical device and pose a risk to a patient’s safety if they do not function properly.  They will regulate apps that “are intended to be used as an accessory to a regulated medical device…or transform a mobile platform into a regulated medical device.” Here are some examples of what type of mobile medical app the FDA regulates.

  • Mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps: These mobile apps use a mobile platform’s built-in features such as light, vibrations, camera, or other similar sources to perform medical device functions
  • Mobile apps that connect to an existing device type for purposes of controlling its operation, function, or energy source and therefore are mobile medical apps: These mobile apps are those that control the operation or function (e.g., changes settings) of an implantable or body worn medical device.
  • Mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device and therefore are mobile medical apps:

Mobile Medical App Developers

“The FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System  regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.”

If the app you are developing requires regulation by the FDA the manufacturer must comply with the proper requirements for the device’s classification.  Developers should contact the FDA with questions about the process.  A mobile medical application is considered a medical device and as such would be responsible for following the policies associated with that classification.

For the full FDA Guidance document read: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf