The FDA announced this week that it will launch a “Digital Health Center of Excellence” within the Center for Devices and Radiological Health (CDRH).
The center will focus on 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.
“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.,” said FDA Commissioner Stephen Hahn in a 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.”
The center will primarily focus on helping both internal and external stakeholders achieve their goals of providing high-quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. This includes creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff.
The center’s first director will be Bakul Patel, who has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.
“The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency,” said CDRH director Jeff Shuren. “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.”