The U.S. Food and Drug Administration issued guidance for developers of mobile medical applications that perform functions similar to traditional medical devices. The guideline outlines the FDA’s tailored approach to mobile apps.

The agency intends to exercise enforcement on a subset of mobile apps that present a greater risk. For example, apps designed to be used as accessories to regulated medical devices and that enable health care professionals to make remote diagnosis. Also on apps intended to transform a mobile platform into a medical device such as an electrocardiography (ECG) machine.

According to the FDA, 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.

For more information, please visit the U.S. Food and Drug Administration website.