The U.S. Food and Drug Administration (FDA) announced today the issuance of its final guidance regarding mobile medical applications, defined by FDA as software programs that run on mobile communication devices and perform the same functions as traditional medical devices. This final guidance finalizes draft guidance that was issued by the FDA on July 21, 2011.
The FDA stated that it “intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.” The regulatory oversight will focus on mobile medical applications that “are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.”
The final guidance includes examples of mobile applications that are not medical devices; examples of mobile applications for which the FDA intends to exercise enforcement discretion; and examples of mobile applications are the focus of FDA’s regulatory oversight. The final guidance also includes a frequently asked questions section.