FDA issues final guidance on mobile medical apps September 25, 2013 General Health Information Technology, Food and Drug Administration 0 The U.S. Food and Drug Administration (FDA) has issued final guidance for developers of mobile medical applications (apps) or software programs that run on mobile communication devices and perform the same functions as traditional medical devices. According to an agency press release, 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. "Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it," the FDA wrote in its opinion. "Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly," the release said. The FDA is focusing its oversight on mobile medical apps 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. 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 agency has cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years. For more information: Mobile Medical Applications Final Guidance Consumer Update: Keeping Up with Progress in Mobile Medical Apps Mobile Medical Applications Web Page Comments are closed.
