The U.S. Food and Drug Administration (FDA) recently released its “Draft Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications.” Citing the quickly expanding field of mobile applications, the FDA released the Guidance to provide information as to how the FDA intends to apply its authority to certain software applications that may be used on mobile platforms.
According to the FDA, at the present time it will extend its regulatory authority to a specific type of mobile application: the “mobile medical app.” For purposes of the Guidance, the FDA defines “mobile medical app” as a mobile app that falls under the definition of “device” in the Federal Food, Drug, and Cosmetic Act and either: (1) is used as an accessory to a regulated medical device or (2) transforms a mobile platform into a regulated medical device. The Guidance explains that the intended use of a mobile application, such as the use shown through marketing or advertising by manufacturers, determines whether such application meets the definition of a “device.”
As set forth in the Guidance, for mobile medical applications that are subject to FDA regulation, manufacturers should satisfy the criteria associated with the applicable device classification. The Guidance provides detailed information on examples of mobile medical applications and regulatory requirements and also seeks comments by October 19, 2011.