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The new center aims to advance digital health technology.
The FDA has announced the launch of the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH).
According to a news release, the center will be an important step in furthering 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 used to study medical products.
“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” FDA Commissioner Stephen M. Hahn, MD, says in the release. “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 FDA aims to continue building and formalizing the coordinating structure and operation of the center as part of an its effort to modernize policies and regulations, as well as providing efficient access to specialized expertise, knowledge, and tools in accelerated access to digital health technology, the release says.