The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. Since then, the agency has received over 130 comments on the draft guidance. The final guidance outlines a “tailored approach” to mobile apps, which apparently received overwhelming support in the comments.
Like the 2011 draft guidance, the final guidance contains nonbinding recommendations for mobile medical apps that meet the definition of “device” under the Federal Food, Drug, and Cosmetic Act and are intended to be used as an accessory to a regulated medical device, or to transform a mobile platform into a regulated medical device.
The FDA intends to exercise “enforcement discretion” and will not regulate apps that pose minimal risk to patients and consumers, including apps that:
- Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to 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 Records (PHR) or Electronic Health Record (EHR) systems.
Instead, the FDA will focus on apps that present a greater risk to patients and consumers if they fail to work as intended, such as apps that:
- Use a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart (electrocardiograph or ECG);
- Use an attachment to the mobile platform to measure blood oxygen saturation for diagnosis of specific diseases or conditions;
- Act as wireless remote controls or synchronization devices for computed tomography (CT) or X-Ray machines; or
- Connect to a nursing central station and display medical device data to a physician’s mobile platform for review (i.e., a medical device data system or MDDS).
Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, stated in an announcement: “Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation.”
The FDA also recognized that “[m]obile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.”
The FDA will use the same regulatory standards and risk-based approach that the agency applies to other medical devices when assessing mobile medical apps that are subject to agency review. The FDA has already approved about 100 mobile medical apps over the past decade, and about 40 of those were cleared in the past two years.
Mobile medical app developers should pay close attention to the final guidance to evaluate whether a premarket application is required. Even before the guidance was finalized, the FDA delivered a mobile medical app inquiry to a developer that failed to obtain premarketing clearance for a urine analyzer app. Because the guidance does not specify all types of mobile medical apps, developers may be unsure as to whether an app is subject to regulatory oversight. Mobile medical app developers are encouraged to seek advice about their mobile apps and whether their apps require premarket FDA approval.