FDA establishes Digital Health Center of Excellence

Although still a work in progress, the new center will reportedly help coordinate digital health projects within the agency while providing expertise to external stakeholders.

The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the agency as well as external stakeholders promote digital health technologies.

Housed within the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence (DHCE) will focus on a range of technologies “mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products,” the agency said. It will be headed by Bakul Patel, who until now has served as director of the CDRH’s Division of Digital Health.