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FDA Issues Long-Awaited Guidance for Mobile Medical Apps

Erin Porter

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The FDA issued long-awaited draft guidance for mobile apps this week, laying out specific definitions and examples of what it considers to be a "mobile platform," a "mobile application" and a "mobile medical app." The guidance focuses specifically on mobile medical apps which are apps that:

  1. Meet the criteria of being a "device" (basically meaning it is intended to aid in diagnosis, treatment, cure, or prevention of disease, or to affect the structure/function of the body)
  2. Are "used as an accessory to a regulated medical device; or transform a mobile platform into a regulated medical device"

In general, if a mobile app is intended for use in performing a medical device function it is considered a medical device, and therefore must go through the associated rigors of extensive device testing and approvals. Since the FDA already regulates traditional medical devices, they believe that mobile medical apps pose the same potential risk if they fail to function as intended, and therefore should be regulated in a similar way as traditional medical devices. In fact, mobile medical apps may pose additional or different risks than traditional medical devices due to unique characteristics of the platform. For example, interpretation of radiological images on a mobile device could be adversely affected by smaller screen size, lower contrast ratio, or uncontrolled ambient light.

The draft guidance was issued by two divisions of FDA responsible for regulating medical devices, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). "The use of mobile medical apps on smart phones and tablets is revolutionizing healthcare delivery," said Jeffrey Shuren, M.D., J.D., director of the CDRH, in a statement. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."

In the draft guidance, FDA laid out its definitions for what does and does not constitute a mobile medical app.

What is a mobile medical app?

  • Mobile apps that are an extension of regulated medical devices for purposes of controlling the device, or displaying/storing/analyzing/transmitting patient data
  • Mobile apps that transform the mobile platform into a regulated medical device by using attachments/sensors
  • Mobile apps that allow the user to input patient-specific information and, using formulas or algorithms, outputs a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or for clinical decision making

What is not a mobile medical app?

  • Mobile apps that are electronic copies of references, textbooks, or teaching materials, used to provide clinicians with training or reinforce previous training
  • Mobile apps used to log, record, track, or evaluate information related to general health and wellness (dietary tracking logs, calorie counters, appointment reminders, exercise suggestions)
  • Mobile apps used for general office operations such as billing, inventory, appointments, or insurance transactions
  • Mobile apps that are generic aids to assist users and are not commercially marketed for a specific indication or disease state (magnifying glass, note-taking tools)
  • Mobile apps that perform the functionality of an electronic health record systems or personal health record systems

What does it all mean?

Further guidance can be expected as technology continues to evolve, but for now the FDA is focusing on a specific group of apps that present the greatest risk to patients when they don’t work as intended. Sanofi-aventis’s "GoMeals" and other similar nutrition apps likely would not fall into the "mobile medical app" category, since they track information related to general health and wellness but do not output clinical recommendations. Symptom tracking apps (examples: Psoriasis tracking apps from Abbott and Janssen) could potentially be subject to regulatory oversight, since an input of specific patient information results in a score or analysis that could influence treatment decisions. Any apps acting as a medical device will be subject to oversight as well.

A public comment period on the draft guidance is open for 90 days, after which the agency will update the guidance based on feedback. Guidelines will surely become more robust as technology continues to change, and as the role of mobile technology in healthcare grows.

Industry reaction

In general, the news was met with positive response from the pharma community. Though some will need to re-evaluate the role of their apps as medical devices and reassess accordingly, most pharma apps (here’s a long list) will fall under the category of "does not apply." Now that the industry has some understanding of FDA’s stance on the topic, we actually expect more — as opposed to less — pharma mobile apps to roll out over time.

More information is available at:

FDA Draft Guidance Article from Medical Marketing & Media Article from MobiHealthNews

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