FDA to Regulate Only 'Small Subset' of Mobile Medical Apps

September 23, 2013

Not all smartphone and tablet apps for health, such as a program reminding patients about an appointment, are regulated medical devices, and not all mobile apps that qualify as medical devices warrant regulation in the first place.

So said the US Food and Drug Administration (FDA) today as it issued final guidelines for this technology that are designed not to squelch a revolution in medicine.

The FDA said it would limit its regulatory oversight to what it calls "mobile medical apps" — true medical devices — that present "a greater risk to patients if they do not work as intended."

The mobile medical apps that will draw FDA scrutiny fall into 3 categories. Those in the first transform a mobile platform such as a smartphone into a device already requiring FDA approval. A good example is an app that turns an iPhone into an electrocardiography (ECG) machine.

Apps in the second category are meant to be used as an accessory to a regulated device — think of a tablet that displays an x-ray from a FDA-approved picture archiving and communication system (PACS) used by radiologists.

The third category consists of mobile medical apps that perform patient-specific analysis and then provide a diagnosis, or treatment recommendations, such as a dosage plan for radiation therapy.

Other than that, most mobile apps in healthcare will not require FDA approval, and some that previously did will no longer need it, said Jeffrey Shuren, MD, director of the agency's Center for Devices and Radiological Health. "Although many mobile apps pertain to health, we are only continuing our oversight for a very small subset of those mobile apps that are medical devices."

"We have focused our priorities, and taken a big deregulatory action, the biggest we've taken in over a decade," said Dr. Shuren at a news conference today.

The FDA also does not intend to regulate smartphones and tablets themselves in their role as platforms for healthcare apps.

"Developers of mobile apps have been asking for guidance about which apps are subject to FDA oversight, and which are not," said Dr. Shuren. "Such clarity is critical for attracting investment and accelerating innovation."

The agency has cleared roughly 100 mobile medical apps for marketing over the past 10 years, and 40 of those during the past 2 years.

Clinical Calculators Will Escape Oversight

The FDA guidance notes that many mobile apps for healthcare lie outside FDA oversight because they do not meet the agency's definition of a medical device, which is any apparatus or machine used to diagnose, prevent, cure, treat, or mitigate illness, or affect the structure or function of the human body primarily apart from chemical action and metabolism. Examples of such apps include:

  • Medical reference materials

  • Medical education tools such as interactive anatomy diagrams

  • General patient education

  • Those that automate office operations such as selecting a diagnostic or billing code

A whole other swath of mobile apps may technically qualify as medical devices, but because they pose such a low risk to patients, the FDA will not require manufacturers to seek agency approval under a policy known as "enforcement discretion." Apps in this category:

  • Help patients manage chronic conditions such as diabetes without providing specific treatment suggestions

  • Help patients organize and track their health information

  • Calculate body mass index, mean arterial pressure, APGAR scores, and other clinical measures

  • Allow both patients and providers to interact with an electronic health records (EHR) system

Additional information on today's announcement, including more examples of mobile apps that will or will not be regulated, is available on the FDA Web site.


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