Digital health to get a bigger voice within the FDA – what that means for manufacturers and marketers

Digital health to get a bigger voice within the FDA – what that means for manufacturers and marketers

Author: Michael Cole

In early October the FDA announced the formation of a nine-person Digital Health Advisory Committee expected to be operational in 2024. Broadly, digital health is defined as AI/ML, augmented reality, virtual reality, digital therapeutics, and remote patient monitoring software and devices. The committee will advise the FDA on the ever-changing role of technology in supporting health. Jeff Shuren, MD, JD, director of the FDA Center for devices and Radiological Health summed up the initiative best – “DHTs are critical for achieving transformation in care delivery. As DHTs advance, the FDA must capitalize on knowledge from inside and outside of the agency to help ensure we appropriately apply our regulatory authority in a way that protects patient health while continuing to support innovation.”