FDA launches office of digital transformation

Sept. 21, 2021

The U.S. Food and Drug Administration (FDA) 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. As part of the establishment of the new office, the agency also announced the appointment of Vid Desai as the agency’s new Chief Information Officer.

The FDA said 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.”

The FDA said it has been working on modernization since September 2019, with the Technology Modernization Action Plan, which laid the groundwork for a 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 involves identifying and executing high-value projects for individual centers and for the agency.

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