On February 9th, 2015 the Food and Drug Administration (FDA) issued final guidance (Guidance for Industry and Food and Drug Administration Staff) on mobile medical applications (apps). Mobile medical apps are mobile apps that meet the definition of a “device” under section 201(h) of the Federal Food, Drug and Cosmetic Act (FDCA 21 U.S.C. 321(h)) and are intended either:
- To be used as an accessory to a regulated medical device; or
- To transform a mobile platform into a regulated medical device.
Thus, categorization as a mobile medical app is determined by the intended use of the mobile app, regardless of the hardware or platform involved. The FDA will also consider the potential risk of mobile apps that meet the above criteria, focusing on those “whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” For lower risk devices, the FDA intends to not enforce requirements under the FDCA (enforcement discretion).
The document states that “when the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.” FDA oversight focus will be targeted toward mobile apps that:
- Serve as an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or analyzing medical device data.
- 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 regulated medical devices.
- Perform patient-specific analysis and provide patient-specific diagnosis, or treatment recommendations.
Appendix C of the final guidance provides a list of mobile medical app examples which will fall under FDA oversight.
Mobile apps for which the FDA intends to exercise enforcement discretion include those that:
- Provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.
- Provide patients with simple tools to organize and track their health information without providing recommendations to alter or change a previously prescribed treatment or therapy.
- Provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference). Apps that provide and contextually-relevant information to users by matching patient-specific information to reference information routinely used in clinical practice to facilitate a user’s assessment of a specific patient.
- Help patients document, show, or communicate to providers potential medical conditions, and are not labelled or promoted for medical use.
- Perform simple calculations generally tailored for clinical use, but retain functionality that is similar to simple general purpose tools such as paper charts, spread sheets, timers or generic mathematical calculators.
- Enable patients and providers with mobile access (view or download) to Personal Health Record (PHR) systems or Electronic Health Record (EHR) systems.
- Meet the definition of Medical Device Data Systems (MDDS) as defined in the classification regulation (21 CFR 880.6310).
Appendix B of the final guidance provides a list of examples of mobile apps for which the FDA intends to exercise enforcement discretion.
Mobile medical apps that fall within a medical device classification are subject to the related requirements. The associated controls for each class of device are outlined below.
- Class I Devices: General Controls, including:
- Class II devices: General Controls (as described for Class I), Special Controls, and (for most Class II devices) Premarket Notification (i.e., 510(k)).
- Class III devices: General Controls (as described for Class I), and Premarket Approval (21 CFR Part 814).
Overall, Class I devices are the least regulated and Class III devices have the most stringent regulations. Appendix D of the final guidance provides examples of medical devices and their regulatory classification, while Appendix E further describes the general controls listed above. Of note, the FDA “strongly recommends” that manufacturers follow the Quality System regulation (including Good Manufacturing Practice) during design and development of all mobile apps that might qualify as a device, presumably to help ensure compliance from the beginning. The FDA views this as important because “the majority of software-related device failures are due to design errors,” which could be identified and corrected during development with the proper regulatory oversight.
Some of the other resources provided by the FDA to guide the industry include:
This guidance is nonbinding and does not establish legally enforceable responsibilities.