Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). In February of this year, the FDA released a revised set of guidance concerning how it will apply regulatory oversight to mobile apps, addressing the growing number and potential uses of these apps as they proliferate alongside rapidly changing mobile technology.

In this new guidance, the FDA set forth three classifications of mobile apps: those that do not meet the definition of a medical device under the FD&C Act, those that may meet the definition but pose a low risk to the public, and those that do meet the definition of a medical device, the functionality of which could risk patient safety in a malfunction. The determining factor in whether an app meets the definition of a medical device for purposes of the FD&C Act is the intended use of the app, which the FDA will determine through labeling, advertising, and statements by the manufacturer. If a mobile app is intended to perform a medical device function, such as diagnosing or curing disease, it is considered a medical device.

While the FDA could regulate all devices it deems meet the definition for “medical device,” it will draw the regulatory line only when there is potential risk to a patient if an app doesn’t perform as specified. These apps include those that connect to other devices to control them or actively monitor patient data, apps that transform a mobile platform into a medical device by using sensors, attachments or display screens, and apps that perform patient-specific analysis, diagnosis, or treatment recommendations.

Apps that function as medical devices but that pose a low risk of harm will escape FDA scrutiny, although the FDA urged manufacturers of all mobile medical apps to abide by Quality System regulations. The list of low-risk app types that the FDA is currently choosing to provide little, if any, oversight over has grown significantly since the last guidance just two years ago.

The guidance is intended to help mobile medical app creators determine if their app falls under FDA regulations, triggering certain controls according to device class (I, II or III). If a mobile app is seen as a medical device, it must conform to applicable regulations concerning device classification and follow regulatory controls, which may include registration, labeling, and premarket notification or approval, among others.