Mobile medical apps are medical devices that are mobile apps, meets the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.
According to FDA definition:
A “mobile medical app” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either is intended:
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.
For example, mobile apps intended to run on smart phones to analyze and interpret EKG waveforms to detect heart function irregularities would be considered similar to software running on a desktop computer that serves the same function, which is regulated under 21 CFR 870.2340 (“Electrocardiograph”).
FDA’s oversight approach to mobile apps is focused on their functionality, just as it focuses on the functionality of conventional devices. FDA's oversight is not determined by the platform. Under this guidance, FDA would not regulate the sale or general/conventional consumer use of smartphones or tablets.
FDA’s oversight applies to mobile apps performing medical device functions, such as when a mobile medical app transforms a mobile platform into a medical device. However, as previously noted, FDA intend to apply this oversight authority only to those mobile apps whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.