FDA Announces Risk-Based Approach to Regulating Medical Apps
The Food and Drug Administration announced recently a “tailored approach” to regulating mobile medical applications, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. Specifically, the FDA intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Food, Drug and Cosmetic Act) for the majority of mobile apps and to focus its regulatory oversight on apps that (a) are intended to be used as an accessory to a regulated medical device (e.g., an app that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet) or (b) transform a mobile platform into a regulated medical device (e.g., an app that turns a smartphone into an electrocardiography machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices. The FDA has cleared about 100 mobile medical apps over the past decade, including about 40 in the past two years.
The FDA notes that it does not regulate the sale or general consumer use of smartphones or tablets, nor does it regulate mobile app distributors such as the iTunes app store or the Google Play store.