The FDA has launched a new center of excellence to oversee digital health products such as smartphone apps, wearable devices and software-based treatments.
It will also promote strategies for the regulation of health IT services and technologies for studying drugs and devices as well as artificial intelligence and machine learning programs.
Going forward, the initiative will serve as a coordinating hub within the agency’s Center for Devices and Radiological Health to assist with related regulatory activities and to provide digital health policy expertise to the FDA as a whole.
The agency appointed Bakul Patel, who has helped lead the FDA’s regulatory and scientific efforts covering digital health devices since 2010, as the new center’s first director.
“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 the FDA’s device center 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,” Shuren added.
The FDA plans to hold virtual listening sessions with the digital health industry this fall as the agency continues to build out the center and refine its purview. The center of excellence will also work to build a network of digital health experts to help develop the FDA’s priorities and launch strategic partnerships with stakeholders in the community.
“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,” FDA Commissioner Stephen Hahn, M.D., said.