FDA Proposes Draft Guidance for Regulating Mobile Medical Device Apps

The FDA has proposed guidelines designed to regulate what it considers to be particularly risky mobile medical device apps. After struggling with piecemeal medical device app regulations over the past year, and in the face of recommendations from industry groups, the FDA has elected to focus on a specific category of apps that could directly affect patient health.

What, exactly, is covered under the new draft guidance for mobile medical applications? The document applies to any app that is “used as an accessory to a regulated medical device,” or that “transform(s) a mobile platform into a regulated medical device,” excluding apps designed to provide reference materials, log or affect general health, fulfill an administrative role, or which function as a health record system. More specifically, the FDA is looking to regulate medical device apps that display, store, analyze or transmit “patient-specific” medical device data, apps that incorporate functionality similar to currently regulated devices or which integrate with these devices as controllers, and apps that are designed to assist in making clinical or patient health-related decisions via the processing of patient information.

What are some examples of the types of apps that would fall under the heading of these new regulations? The guidance document mentions remote patient-specific data display apps, apps that can control insulin pumps or interact with sensors while gathering patient information, and apps that provide a prognosis based on patient symptoms and other information.

The FDA has stressed that the draft guidance refers exclusively to mobile medical device apps and also that the Administration is not finished with its evaluation of the mobile app spectrum. At a meeting of the California Healthcare Institute this past month, an FDA spokesman indicated that the 510(k) process would eventually only apply to a small subset of anticipated future medical device apps.  Additional mobile medical device use scenarios will be addressed by their own specific guidance documents. The current draft guidance is subject to a 90-day comment period, which will begin this month.

With an estimated 200 million mobile health applications currently available, this area of the medical device industry will require significant federal resources to properly regulate while still maintaining the growth and innovation required to provide Americans with an affordable and safe level of health care. The FDA expects 500 million smartphone users to have medical device apps on their platforms within the next four years, with half expected to be personal monitoring devices.  MDCI will continue to keep a close eye on this impending legislation, as well as any future regulatory changes targeting mobile medical device apps.

Benjamin Hunting
MDCI Blogging Team