The U.S. Food and Drug Administration (FDA) has announced the launch of its Digital Health Center of Excellence, which will be within the Center for Devices and Radiological Health (CDRH).
The Center will aim to further the agency’s goal of advancing digital health technology, including mobile health devices, software as a medical device (SaMD), wearables used with medical devices, and technology to study medical products.
“Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. 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,” said FDA Commissioner Stephen M. Hahn, MD in a recent press release.
The agency will appoint Bakul Patel as the first director, who has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.
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