Not every smartphone or tablet app related to health, like an app reminding patients about an appointment, are regulated medical devices. Additionally, not all mobile apps that meet the criteria as medical devices are awarded regulation to begin with, noted the US Food and Drug Administration (FDA) as it issued final guidelines for this technology that are aimed not to squander a revolution in medicine.
The FDA said it would confine its regulatory supervision 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 medical mobile apps that are subject to heavy examination by the FDA can fall into one of three categories. Those that are placed in the first category alter a mobile platform such as a smartphone into a device already in need of FDA approval. A prime example of this is an app that turns an iPhone into an electrocardiography (ECG) machine.
Mobile medical apps found in the second category are supposed to be utilized as an accessory to a regulated device, for instance a tablet that showcases an x-ray from a FDA-approved picture archiving and communication system (PACS) used by radiologists.
While the third and final category includes mobile medical apps that carry out patient-specific analysis and then offer a prognosis, 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. 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 director of the agency's Center for Devices and Radiological Health, Jeffrey Shuren, MD.
Moreover, the FDA does not plan to regulate smartphones and tablets themselves in their respective service 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 Shuren. "Such clarity is critical for attracting investment and accelerating innovation."
Around 100 medical mobile apps have been granted approval for marketing by the FDA within the last decade, 40 of those coming within the past two years.
The FDA guidance board states that many mobile apps for healthcare remain outside FDA jurisdiction because they do not meet the agency's criteria 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.” Some 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 group of mobile apps may technically be eligible 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
More detail on which mobile medical apps that will or will not be regulated can be found on the FDA’s website.
