FDA launches Digital Health Center of Excellence

The U.S. Food and Drug Administration (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.

Bakul Patel has been appointed the first director of the center. He has been a regulatory and scientific efforts related to digital health devices at the FDA since 2010, the release says.

The Digital Health Center of Excellence will primarily focus on getting high quality digital health technologies to patients by providing technical advice, coordinating, and supporting work being done across the FDA. It is creating a network of digital health experts and engaging in collaborative communities to share knowledge and experience with digital health issues and FDA staff priorities, the release says.

The launch includes activities like launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships, the release says.