On September 25, 2013, the Food and Drug Administration (FDA) issued final guidance on Mobile Medical Applications – healthcare related software applications intended for use on mobile platforms such as smartphones and tablets (i.e., mobile apps). FDA intends this document to provide guidance to mobile app manufacturers, distributors, and others regarding what apps are considered to be medical devices, and, of those, which apps are likely to be subject to active FDA oversight versus limited FDA regulation.
The Mobile Medical Application (MMA) Guidance provides a useful tool for determining what applications FDA will regulate in the mobile medical sphere, but it does not provide specifics regarding how it will regulate those products. Specifics of the overall regulatory framework for health-related mobile apps will be worked out through further consultation with FDA and other agencies and offices (including the Federal Communications Commission (FCC), Center for Medicare and Medicaid Services (CMS), and the Office of the National Coordinator for Health Information Technology (ONC)) as appropriate depending on device functionality. It will be important to monitor and understand those specifics as they are rolled out to ensure compliance. Additionally, the MMA Guidance expressly states that it does not address the regulatory approach that will apply to mobile apps and other software that perform patient-specific analysis to aid in or support clinical decision-making – commonly referred to as Clinical Decision Support (CDS) software. FDA has indicated that future guidance is forthcoming that will address the specifics of a regulatory framework for CDS software.
For now, the MMA Guidance establishes a relatively hands-off approach to FDA’s regulation of health-related mobile apps, stating that FDA intends to actively regulate only those apps that “are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.”
By focusing on app functionality and related risk potential, FDA anticipates that the majority of currently marketed mobile apps would avoid FDA’s regulatory scrutiny because (1) the apps will not meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (FFDCA); or (2) FDA intends to exercise enforcement discretion (meaning it will not enforce the FFDCA’s device-related requirements) regarding many low risk apps that may technically qualify as medical devices under the law.
Nevertheless, companies engaged in the manufacture, marketing, and distribution of health-related mobile apps should review the MMA Guidance carefully, including the detailed Appendices listing very specific examples, to assess whether their specific existing or planned apps are likely to be subject to FDA’s regulatory oversight or whether they will benefit from FDA’s enforcement discretion. Since mobile technology and app development is constantly changing, consultation with regulatory counsel in conjunction with the app development process would be prudent and could save time and allow minimization of regulatory restraint.
A basic overview of the MMA Guidance, along with references to specific practical examples from the guidance itself, is provided below.
SCOPE OF FDA OVERSIGHT – A RISK-BASED APPROACH
The MMA Guidance indicates that FDA may apply its regulatory oversight to any mobile app that qualifies as a medical device under the FFDCA and (1) is intended to be used as an accessory to a regulated medical device, or (2) transforms a mobile platform into a regulated medical device.
Apps that meet these criteria are defined by FDA as “Mobile Medical Apps,” and this definition provides a framework for determining the broad categories of mobile apps that may be subject to FDA regulation. Indeed, all of the mobile apps to which FDA intends to apply its regulatory oversight, requiring compliance with the FFDCA, will meet the definition of a Mobile Medical App. However, more important than the definition is an analysis of patient risk based on a mobile medical app’s intended function. As discussed above, FDA only intends to apply its regulatory oversight to Mobile Medical Apps whose functionality could pose a risk to a patient’s safety if the app failed to function as intended.
The MMA Guidance identifies several categories of Mobile Medical Apps that will be subject to active FDA regulation. These categories are based on the functions that the Mobile Medical Apps perform. The categories for which FDA considers the patient risks to warrant active regulatory oversight include:
Apps that function as accessories to other regulated medical devices – These mobile apps act as an extension of another device that has been approved, cleared, or otherwise classified by FDA. Apps may act as an extension to a regulated device by connecting the mobile platform (by wires or wirelessly) to another regulated device and controlling the device or displaying, storing, analyzing, or transmitting patient-specific data from the device. Examples include apps that permit the remote display of data from bedside monitors or other devices, apps that provide the ability to control the inflation/deflation of a blood pressure cuff, or apps that control the delivery of insulin from an insulin pump.
Because they are considered to be accessories to their respective connected devices, FDA expects that apps in this category will generally be required to comply with the regulations and controls applicable to the particular devices to which they are linked – thus addressing the same risks associated with that type of device.
Apps that convert the mobile platform into a regulated medical device – These mobile apps (often by using attachments, display screens, or sensors) make it possible for a mobile platform to perform the function of an approved or cleared medical device. These kinds of mobile apps transform the mobile platform into a regulated medical device in its own right. Examples include apps that permit the platform to read blood glucose test strips; to measure, store, and display ECG signals, to act as an electronic stethoscope, or to produce controlled tones used for a diagnostic hearing evaluation.
Because these apps cause the mobile platform to behave like other, previously classified medical devices, the apps are required to comply with the same regulations and controls applicable to the particular type of device that an app is transforming the mobile platform to be.
Apps that act as regulated medical device software – These apps are similar to, and perform the same function as, software for other computing platforms that provide patient-specific analysis, patient-specific diagnosis, and/or treatment recommendations. Examples include Computer Aided Detection (CAD) software or apps that use patient specific data and algorithms to create dosage plans for radiation or other therapy. Additionally, although the Guidance does not provide a specific regulatory framework for CDS apps, it should also be noted that CDS apps, which are used by patients and clinicians to support medical decisions, appear likely to fall under this category of regulated apps.
FDA believes that this type of software presents the same level of risk to patients regardless of the computing platform on which it runs, and FDA encourages medical device software developers to contact the agency to discuss any applicable regulatory requirements.
The MMA Guidance also identifies several categories of Mobile Medical Apps, based on functionality and risk, for which FDA intends to exercise enforcement discretion and for which the agency will not enforce the FFDCA’s medical-device requirements. These categories include:
Coaching or health management apps – These apps supplement clinical care by providing day-to-day coaching or self-management tools for patients with specific diseases or identifiable health conditions. They do not, however, provide specific treatment or treatment suggestions. For example, apps that help patients with conditions like cardiovascular disease or diabetes by promoting strategies for nutrition, exercise, or weight maintenance, or by helping patients adhere to a pre-determined medication dosing schedule.
Health information tracking and organization apps – These apps provide patients with simple tools to organize and track health information pertinent to specific diseases or conditions without providing recommendations that would alter or change a previously prescribed treatment or therapy. For example, apps that allow patients with obesity, anorexia, arthritis, or heart disease to log, track, or trend events or measurements such as blood pressure, drug intake times, diet, or emotional state and that may permit this information to be shared with a health care provider.
Apps providing information related to patients’ health conditions or treatment – These apps provide specific health reference information tailored to patient-specific diagnoses, treatments, allergies, symptoms, or other patient-specific inputs. In this way these apps go beyond simply providing an electronic copy of a medical reference. For example, apps that provide a physician with current treatment guidelines related to a specific condition or drug interaction look-up tools.
Apps marketed to help patients document, show, or communicate information about their medical conditions – These apps are demonstrational and facilitate communication, but they are not promoted for medical uses. For example, apps that serve as videoconference portals or apps that use a mobile device’s camera for documenting visual images that can augment and clarify the verbal communication between a patient and a health care provider.
Apps that perform simple calculations routinely used in clinical practice – These apps may replace charts, spreadsheets, timers, or generic calculators used by health care practitioners to perform simple calculations taught in medical school. For example, apps for calculating body mass index, mean arterial pressure, APGAR score, NIH stroke scale, or delivery date estimation.
Apps that enable patients to gain mobile access to electronic health record information – These apps are generally meant to facilitate general health information management and record keeping.
In addition to describing the categories discussed above, the MMA Guidance and its Appendices provide several other detailed examples of the types of apps that will be regulated by FDA as Mobile Medical Apps and those that may warrant enforcement discretion. Manufacturers of health-related mobile apps can use these examples to inform the case-by-case analysis regarding the likely regulatory status of their specific mobile apps. Additionally, the MMA Guidance encourages mobile medical app manufacturers, particularly manufacturers developing an app for an entirely new health-related use, to contact FDA to discuss the regulatory requirements that may be applicable.