FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation

FDA News Release

• For Immediate Release: September 15, 2021

Today, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level. This reorganization will advance the agency’s information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission.

The reorganization is a significant step in the FDA’s technology and data modernization efforts that began more than two years ago. The reorganization allows the FDA to bring more effective and efficient data and IT management, built on best practices, to streamline and advance FDA operations by reducing duplicative processes, implementing technological efficiencies using projects that deliver the most customer benefits, and promoting shared services within agency offices and centers to strategically and securely further the agency’s regulatory mission.

“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said Acting FDA Commissioner Janet Woodcock, M.D., “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do. By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products that the FDA regulates in this complex world. This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level.”

The FDA has been undertaking a modernization effort since September 2019, with the Technology Modernization Action Plan, which laid the groundwork for the more-modern approach to the use of technology for the agency’s regulatory mission, including looking at innovative ways for the review of medical product applications, food safety and other critical functions. That was followed by the Data Modernization Action Plan, announced earlier this year, which built upon the successful streamlining and process improvements started in 2019 to identify and execute high value driver projects for individual centers and for the agency. As part of the establishment of this new office, the agency is also announcing the appointment of Vid Desai as the agency’s new Chief Information Officer.

The FDA FY 2022 budget request included funding to support the agency’s data and IT modernization efforts for enterprise-wide data modernization, demonstrating the commitment to and the progress of these institutional changes.