Last week, the FDA announced the publication of its final guidance for mobile medical apps. The FDA issued this guidance to inform manufacturers, distributors, and other entities about how the agency intends to apply its regulatory authority to select software applications for use on mobile platforms (“mobile apps”). By way of background, the guidance states:
“As mobile platforms become more user friendly, computationally powerful, and readily available, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer. Some of these new mobile apps are specifically targeted to assisting individuals in their own health and wellness management. Other mobile apps are targeted to healthcare providers as tools to improve and facilitate the delivery of patient care.”
The FDA issued this guidance because, as is the case with traditional medical devices, certain mobile medical apps could pose potential risks to public health. One risk factor that separates mobile apps from traditional devices is that some apps may pose safety concerns simply due to the platform on which the mobile medical app is run. For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform. The FDA intends to take these risks into account in assessing the appropriate regulatory oversight for these products.
The final guidance clarifies the subset of mobile apps to which the FDA intends to apply its authority. To that end, the FDA has divided all mobile apps into three categories for regulatory purposes:
1. Apps that are NOT medical devices
2. Apps for which FDA intends to exercise enforcement discretion
3. Apps that are the focus of FDA’s regulatory oversight (“mobile medical apps”)
Many mobile apps are not medical devices (meaning they do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act), and the FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, the FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). The majority of mobile apps on the market at this time fit into these first two categories.
An example of a mobile app that is not a mobile medical app (i.e. would fall into the first category above) is an app that provides access to e-books or audio books of medical dictionaries, or encyclopedic references of diseases and/or emergency care information. An app that provides general guidance for patients to ask appropriate questions to their physician, or one that helps Celiac’s sufferers find gluten-free products, would also fall into this first category.
An example of a mobile app over which the FDA would exercise enforcement discretion (second category above) is an app that would provide patients with simple tools to organize and track their health information, without providing specific treatment or treatment suggestions. Another example would be an app that provides simple medical calculations that are routinely used in clinical practice, such as Body Mass Index (BMI) calculations or a delivery date estimator for expectant mothers.
As for the third category, the FDA intends to apply its regulatory oversight to mobile apps that are considered medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. It is this subset that the FDA refers to as “mobile medical apps.”
In addition to meeting the definition of “device” in 201(h) of the FD&C Act, a mobile medical app is intended either to be used as an accessory to a regulated medical device, or to transform a mobile platform into a regulated medical device. “Intended use” may be shown by labeling claims, advertising materials, or oral or written statements made about the product by manufacturers or their representatives. For the most part, when the intended use of a mobile app is for the diagnosis of disease or other condition, or the cure, mitigation, treatment, or prevention of disease, the mobile app is considered a “device” and is thus regulated as a “mobile medical app.”
The FDA’s oversight approach to mobile medical apps is focused on their functionality, just as the agency focuses on the functionality of conventional devices. For example, say a mobile app is promoted as one that can make a light emitting diode (LED) operate. If the manufacturer intends the app to illuminate objects generally (i.e., without a specific medical device intended use), the app would not be considered a medical device. If, however, through marketing, labeling, and the circumstances surrounding distribution, the app is promoted by the manufacturer for use as a light source for doctors to examine patients, then the intended use of the light source would be similar to a conventional medical device, and as such the app would qualify as a mobile medical app.
So what do manufacturers of these novel devices need to know? Most importantly, manufacturers of mobile medical apps must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification, its manufacturer is subject to the requirements associated with that classification. Just like conventional devices, a mobile medical app may be classified as class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval).
In addition, just as with conventional medical devices, mobile medical app manufacturers are required to annually register their place of business with the FDA, and must also provide the FDA with a list of all the devices they market. Mobile medical app manufacturers must also comply with the same labeling regulations that apply to traditional medical devices.
While conventional medical devices aren’t going away any time soon, publication of the FDA’s final guidance on mobile medical apps marks a significant step in the ever-evolving, increasingly digitized nature of health care services available to physicians and patients in this country. With technological advancements such as the increase in social media marketing and the use of mobile medical apps, manufacturers should be sure to keep up to speed on the various regulatory requirements that accompany these new industry tools. We here at the Monitor will continue to stay on top of FDA developments and will keep you informed of the regulatory landscape.