FDA Issues Draft Guidance Document on Mobile Medical Apps

By Carmelina G. Allis –

The FDA’s “Draft Guidance on Mobile Medical Applications” is applicable to software products (or “mobile apps”) intended for use on mobile platforms that are handheld in nature, such as, for example, the iPhone® and Android® phones.  “Mobile medical apps” are defined as software applications that meet the statutory definition of a “device” under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, and are either used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device.

The FDA plans to exercise regulatory oversight over those mobile medical apps that are associated with current device classifications.  Thus, the guidance document focuses on mobile apps that perform functions that either have been traditionally considered medical devices, or that affect the performance or functionality of a currently regulated medical device.  Examples include mobile apps that are an extension of one or more medical devices by connecting to such device for storing or displaying patient-specific medical data (e.g., an app that displays medical images directly from a PACS server), or mobile apps that allow the user to input patient-specific information and uses algorithms to obtain a patient-specific results or diagnosis (e.g., apps that collect patient-specific data and compute the prognosis of a particular disease).

FDA also identifies the categories of mobile medical apps for which it will apply regulatory oversight.  Those categories are:

• displaying, storing or transmitting patient-specific medical device data in its original format;
• controlling the intended use, function, modes, or energy source of the connected medical device;
• transforming or making the mobile platform into a regulated medical device; and
• creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data.

The guidance document clarifies that mobile apps that are electronic copies of textbooks, reference materials or teaching aids; that are used to make decisions regarding general health and wellness; or that only automate general office operations, such as billing, are not considered mobile medical apps.

This document also clarifies that a mobile platform is not a “device” simply because it can be used to run a mobile medical app.  However, if the platform is being marketed with a medical device intended use, then it would meet the definition of a “device.”

Although this guidance document provides much needed clarification on how the agency intends to regulate mobile medical apps, it still leaves uncertainty in some areas.  For example, FDA intends to exercise “enforcement discretion” against those mobile apps that do not meet the definition of a “mobile medical app” but may meet the statutory definition of a “device.”  This approach will create uncertainty for industry.  Moreover, there are other mobile apps that FDA will “monitor” and “determine whether additional or different actions are necessary to protect the public health.”  Examples of mobile apps that FDA will “monitor” are products that may meet the definition of a “device” and also automate common clinician’s diagnostic and treatment tasks, or allow individuals to self-manage their disease.  Because the agency has not defined its regulatory position on those apps that it will “monitor,” FDA seems to suggest that manufacturers should consider complying with device regulatory requirements for these types of apps.  This position will generate further uncertainty and unnecessary expense.

FDA is seeking comments on this draft guidance document.