Mobile Applications As Medical Devices

On July 21, 2011, the Food and Drug Administration outlined the beginning stages of its oversight of mobile medical applications that are designed for use on smart-phones and other mobile computing devices. The medical mobile applications, or “apps” as they are called are so widely used it is estimated that 500 million individuals will be using one by 2015. Apps can be downloaded for a variety of tasks, including to help an individual manage their medications, track their food consumption or allow a physician to view patient charts.

Jeffrey Shuren, M.D., J.D., the director of the FDA’s Center for Devices and Radiological health stated that the the “use of mobile medical apps on smart phones is revolutionizing health care delivery.” While revolutionizing an industry, the FDA is concerned with what happens when the apps don’t work as intended or needed. The FDA’s regulation of these apps begins with a 29 page draft guidance that both defines what a medical mobile application is, as well as explaining and outlining the FDA’s intended regulatory approach.

Medical mobile apps that will fall under the FDA’s oversight are those that are:

  • (1) used an accessory to a regulated medical device; or
  • (2) transform a mobile platform into a regulated medical device.

For example, a mobile app that uses attachments, display screens or sensors by including functionality of a currently regulated medical device, such as stethoscope or blood glucose strip meter would fall under the FDA’s oversight. Other apps, including apps that are copies of medical reference texts used solely to provide clinicians with training, will not be regulated at this time by the FDA.  The FDA is seeking input and comments from the industry and public on the guidance by October 19, 2011.

The FDA expects that mobile app manufacturers and designers will comply with the associated controls established by the applicable device classification regulation. Interestingly, the only mention of mobile application distributors (such as the iTunes store) is at the end of the guidance, when it is noted that distributors will be expected to cooperate with manufacturers to update and remove applications as necessary.

The draft guidance also had no mention of regulating third party manufacturers that create physical accessories or attachments that allow a mobile app to to maintain the functionality of a currently regulated device.  The draft guidance is scheduled to be part of the discussion at two upcoming industry conferences, where it is likely to be the topic of great debate. Where do you foresee the future of the FDA’ regulation of mobile applications? Will you weigh in on the draft guidance?