FDA Establishes New Office of Digital Transformation

The US Food and Drug Administration (FDA) has established a new Office of Digital Transformation to reorganize the agency’s information technology (IT), data management, and cybersecurity functions.

The Office will report directly to the FDA Commissioner. 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 (CIO). Prior to joining the FDA, he held CIO roles at Vyaire Medical, a respiratory medical device company formed from a divestiture from Becton Dickinson and was CIO at Endochoice, a medical device and services provider, and Lake Region Medical, which was acquired by Greatbach to form Integer, a medical device, outsource manufacturer. His previous experience also includes IT leadership roles with Quintiles Transnational and GlaxoSmithKline.

The reorganization aligns FDA’s technology and data modernization efforts that began more than two years ago. The reorganization allows the FDA to bring data and IT management to streamline and advance FDA operations by reducing duplicative processes, implementing technological efficiencies, and promoting shared services within agency offices and centers.

The FDA has been aiming for a modernization effort since September 2019, with the Technology Modernization Action Plan, which laid the groundwork for 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 plan was followed by the Data Modernization Action Plan, announced earlier this year (2021), which built upon the streamlining and process improvements started in 2019 to identify and execute projects for individual centers and for the agency.

Source: US Food and Drug Administration