Division of Clinical Research

Office of the Vice President and Innovation

The U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). This center will further the agency’s dedication to 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 Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff. It is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. While there are many aspects of the Digital Health Center of Excellence that remain under development, the goal is to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

For more information, visit the new FDA website  

Link: www.fda.gov/medical-devices/digital-health-center-excellence

Categories FDA Regulatory, Uncategorized
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