By Miriam Swedlow

Let’s face it; the FDA has a tough job. It must navigate the thin line between balancing public safety and facilitating business innovation. It is perpetually in the zone of “damned if they do and damned if they don’t.” This scenario is currently playing out in the relatively new concept of mHealth, a term used to describe medical services delivered over a mobile device (“m” is for mobile).

The past decade has seen an explosion in health and medical-related apps available to medical professionals and consumers. Apps provide access to medical textbooks or allow users to track health data such as calories and blood pressure. Apps can also directly connect to medical devices such as blood pressure cuffs or cardiac leads, or allow doctors to remotely monitor a patient in real time. Given the broad range of applications, the FDA has struggled to determine when an app becomes a medical device subject to regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). On February 9, 2015 the FDA published its updated Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications. Despite providing manufacturers some clarity, the Guidance falls short of creating a clear indication of what will or will not fall within FDA oversight.

CLEAR BOUNDARIES

The Guidance does create some clear distinctions. It defines what the FDA considers a mobile platform, a mobile application (or mobile app), a mobile medical application (or mobile medical app), a regulated medical device, and a mobile medical app manufacturer. It makes clear that the FDA does not consider mobile app distributors such as “Google play,” “iTunes App store,” and “BlackBerry App World” to be medical app manufacturers.

These definitions also emphasize that the FDA is only concerned with apps that meet its definition of a mobile medical app. Therefore, an app may self-describe itself as a “medical” or “health-related” app and still not meet the FDA’s definition for being a mobile medical app. The Guidance provides examples of categories of apps that the FDA does not consider mobile medical devices, putting them into 5 general categories:

1. Apps intended to provide access to “copies” of medical textbooks or reference materials;
2. Apps intended for use as educational tools for medical training or reinforcement learning;
3. Apps intended for general patient education and that facilitate access to reference information;
4. Apps intended for administrative or operational purposes; and
5. Apps that are generic in nature and not specific to medical purposes.

While the FDA is concerned with what it considers “mobile medical apps,” it is not planning on regulating all mobile medical apps at this time. The Guidance states it will “apply its regulatory oversight to only those mobile apps… whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” Specifically, the FDA will regulate mobile medical apps that “can transform a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods.” These devices fall into three general categories:

1. Those that can control a medical device, that can be used for active patient monitoring, or that can be used for analyzing medical device data;
2. Those that use attachments, screens, or sensors that essentially turn the mobile platform into a regulated medical device; and
3. Those that provide patient-specific analysis AND provide patient-specific diagnosis or treatment recommendations.

The FDA is clear in who and what it will definitely not regulate. It is also clear about who it definitely will regulate. It is less clear in who and what it might regulate.

THE MURKEY CENTER

The FDA contends that it “intends to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act)” for an app that meets its definition of a mobile medical app BUT does not pose a risk to patient safety if it does not run as intended. Despite this disclaimer, the Guidance also “strongly recommends” that manufacturers of these apps follow Quality System regulations for these apps. More significantly, the agency stipulates, “manufacturers must meet requirements associated with the device classification.” Mobile medical apps that fall within established medical device classifications are subject to requirements of that classification. Essentially, the FDA is telling manufacturers of certain mobile medical devices that they are subject to regulation… “but our current thinking is that we’re not going to hold you to it.” The agency appears to be talking out of both sides of its mouth, leaving manufacturers of many mobile medical apps uncertain of their responsibilities.

The recent Guidance reflects the agency’s reluctance to forestall innovation and progress, while trying to reassure the public that it is keeping them safe. Although this is the best offering so far from the FDA, it fails to provide clear guidance for manufacturers of thousands of existing and future apps.