Guidance on FDA Regulation of Medical Mobile Apps
Version date: July 10, 2014
Many mobile apps are not medical devices (they do not meet the definition of a medical device under FDA regulations). Some mobile apps do meet the definition of a medical device, but because they pose little risk the public, the FDA intends to exercise enforcement discretion (meaning it will not enforce regulatory requirements with respect to such apps). A smaller subset of mobile apps that meet the definition of a medical device will be regulated by the FDA.
This guidance document includes important definitions and provides examples of mobile apps that are not medical devices, that are medical devices but will not be regulated by the FDA, and that are medical devices and will be regulated by the FDA.
This summary is derived entirely from the document available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf.
Mobile Platforms: A mobile platform is a commercial off-the-shelf computing platform, with or without wireless connectivity, that is handheld in nature.
Mobile App: A software application that can be run on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.
Mobile Medical App: A mobile app that meets the definition of “device” under the Federal Food, Drug, and Cosmetic Act1, and either is intended:
- to be used as an accessory to a regulated medical device; or
- to transform a mobile platform into a regulated medical device.
The intended use of a mobile app determines whether it meets the definition of a “device.” In general, if a mobile app is intended for use in performing a medical device function (i.e. for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease) it is a medical device, regardless of the platform on which it is run.
Mobile Medical App Manufacturer: Individuals who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This does not include persons who manufacture mobile medical apps solely for use in research, teaching, or analysis and do not introduce such devices into commercial distribution; however, these persons may be subject to investigational device exemption regulations. Additionally, licensed practitioners, including physicians, dentists, and optometrists, who manufacture a mobile medical app or alter a mobile medical app solely for use in their professional practice or solely within their practice group (but do not make it generally available to other providers) are not considered medical device app manufacturers.
1 Defined as: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -
- recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Intended Regulatory Oversight
The FDA intends to regulate only those mobile apps that qualify as a “medical mobile app” as defined above. FDA will apply its enforcement discretion to mobile apps that may qualify as a medical device but which pose a low risk to the public.
A. Mobile apps that are not regulated medical devices.
Mobile apps that are intended to be used as reference materials or educational tools, or that automate general office operations, and that are not intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease or condition are not medical devices regulated by the FDA.
Examples include apps that are: medical dictionaries; electronic copies of medical textbooks; medical abbreviations and definitions; medical flash cards; interactive anatomy diagrams or videos; surgical training videos; guides to help patients ask appropriate questions of their providers; or that help match patients to clinical trials; match pill descriptions to their names; determine billing codes; analyze insurance claims for fraud; manage shifts for physicians; or manage or schedule hospital rooms.B. Mobile apps that that are medical devices but which FDA intends to exercise its enforcement discretion (i.e. FDA does not intend to enforce requirements for these apps)
Even though these mobile apps may meet the definition of a medical device, FDA intends to exercise enforcement discretion. These are apps that:
- Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to patients’ health conditions or treatments;
- Help patients document, show, or communicate potential medical conditions to health care providers;
- Automate simple tasks for health care providers; or
- Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.
Examples include: (a) mobile apps that provide supplemental care, such as by coaching or prompting, to help patients manage their health in their daily environment (e.g. help patients maintain a healthy weight, exercise and stay fit, adhere to predetermined medication dosing schedules, or managing salt intake); (b) apps that provide easy access to information related to patients’ health conditions or treatments beyond providing an electronic copy of a medical reference (e.g. use a patient’s diagnosis to provide a clinician with best practice treatment guidelines for common illnesses or conditions such as influenza, or are drug-drug interaction or drug-allergy lookup tools); and (c) apps that perform simple calculations routinely used in medical practice (e.g. calculation of body mass index, mean arterial pressure, Glascow Coma Scale Score, or estimated delivery date).C. Mobile apps that that are medical devices and which FDA intends to regulate
FDA will regulate those mobile 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. These include the following:
- Mobile apps that are an extension of one or more medical devices by connecting such devices for purpose of controlling the device or displaying, storing, analyzing, or transmitting patient-specific medical device data. These mobile apps are required to comply with the controls applicable to that connected device. For instance, if the connected device is 510(k) cleared, then the mobile app would also require 510(k) clearance.
Examples include apps that provide remote display of data from bedside monitors; that control inflation and deflation of a blood pressure cuff; and that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.
- Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently registered medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
Examples include apps that allow the user to attach a blood glucose strip reader to a mobile platform to act as a glucose meter; and apps that use the built-in accelerometer on a mobile platform to collect information for monitoring sleep apnea.
- Mobile aps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.