The FDA announced this week the creation of the Digital Health Center of Excellence for the Center for Devices and Radiological Health (CDRH). Its establishment is another step in the agency’s goal for modernizing digital health policies, regulatory approaches, and the advancement of digital health technology – such as mobile health devices, Software as a Medical Device (SaMD), and wearables. The Digital Health Center of Excellence plans to foster and accelerate innovation via strategic partnerships, providing increased awareness, understanding, and access of digital health technologies, knowledge, and tools for stakeholders. The group will also help streamline and coordinate work across the agency to further ensure consistent application of policies and oversight.
Bakul Patel has been named as its first director. Patel, who joined the agency in 2008, was previously “leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.”
FDA Commissioner Stephen M. Hahn, M.D. stated in the news 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 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.” Jeff Shuren, M.D., J.D., director of CDRH, added that this Digital Health Center will “amplify the digital health work that is already being done and building upon years of work at the agency. In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”