FDA Introduces Office of Digital Transformation

FDA announced the reorganization of the agency’s information technology (IT), data management, and cybersecurity function into the new Office of Digital Transformation (ODT) on Sept. 15, 2021. Vid Desai has been appointed as the ODT’s chief information officer.

ODT will function on an agency level and report directly to the FDA commissioner. The goal behind this reorganization, according to the press release, is to transform the way the agency handles IT via improved data and IT competencies. It will streamline various FDA operations by reducing duplicate processes, implementing technological efficiencies through projects that deliver maximum customer benefits, and promoting shared services within agency offices.

The ODT is the latest step in FDA’s Technology Modernization Action Plan from 2019, which laid the groundwork to innovate the agency’s approach to data management and review process. It was followed by the Data Modernization Action Plan in 2021, which further iterated on various streamlining and processing improvements that began in 2019 by identifying high value driver projects for individual centers and the agency.

“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 Janet Woodcock, acting FDA commissioner, in the press release. “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 [FDA] regulates in this complex world.”

Source: FDA