FDA intends to adopt a tailored approach that supports innovation but at the same time protects consumer safety.
Recently, the U.S. Food and Drug Administration (FDA) issued final guidance concerning the regulation of mobile medical applications that have the potential to harm consumers if they do not function correctly.
The FDA intends to adopt a tailored approach that supports innovation but at the same time protects consumer safety. It intends to focus more on mobile medical apps that present a greater risk to patients if they do not work as intended rather than those that pose minimal risk to consumers.
The agency says it will regulate apps that would be used as an accessory to a regulated 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.
The FDA states it would only regulate products that transform smartphones into devices the agency currently regulates, such as electrocardiography (ECG) machines that can diagnose abnormal heart rhythms or determine if a patient is experiencing a cardiac arrest.
The agency also says it would not regulate the sale or general consumer use of smartphones or tablets or mobile app distributors such as the iTunes App store or Google Play.
FDA Center for Devices and Radiological Health director Dr. Jeffrey Shuren says some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly.
"The FDA's tailored policy protects patients while encouraging innovation," Shuren says.
The FDA will assess the functioning of mobile medical apps on the same regulatory grounds and risk-based approach that the agency applies to other medical devices.
The agency has cleared about 100 mobile medical apps over the past decade, including products that can diagnose abnormal heart rhythms or help patients monitor their blood sugar. About 40 apps were cleared within the past two years.