The US Food and Drug Administration (FDA) launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The centre will focus on promoting and creating digital health technology, including mobile health devices, software as a medical device (SaMD), wearable medical devices, and technologies used to study medical products. The centre aims to assist stakeholders in providing digital health technologies to patients, co-ordinating and supporting work being done across the FDA in the topic, promoting best practices in the field, and possibly revising digital health devices regulation.