The U.S. Food and Drug Administration (FDA) launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to spur the advancement of digital health technology, including 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.
The FDA said the Digital Health Center of Excellence is part of an effort to “modernize digital health policies and regulatory approaches, and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology.”
The FDA also said the Digital Health Center of Excellence will create a network of digital health experts and collaborative communities to share knowledge and experience about digital health issues and priorities with the FDA staff.
