U.S. Food and Drug Administration (FDA): Device Software Functions Including Mobile Medical Applications

Software functions include mobile applications that fulfill the criteria of being a device that may be utilized on mobile platforms, the functioning of a hardware device, or other general-purpose computing platforms. Mobile medical apps are mobile applications that meet the criteria of being a medical device and are a part of a regulated medical device or have the ability to modify a mobile platform into a regulated medical device. These applications help people in their health management, retrieve useful information at their comfort, and encourage healthy living. Mobile medical apps also help healthcare providers achieve better patient care by providing guidance for diagnosing and treating various diseases.