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FDA has formally opened an Office of Digital Transformation as part of a broader effort to modernize and strengthen its information technology, data management and cybersecurity capabilities. With a mandate to report directly to FDA’s commissioner, the new office is designed to adapt its IT and data functionalities to the regulatory needs of an increasingly digitally driven world.
The opening of the new office is the latest step in an effort to bring technological updates to the agency that began two years ago. The reorganization streamlines FDA’s data and IT management by reducing duplicative processes, strengthening policies that benefit companies the most, and connecting agency offices and centers. The Technology Modernization Action Plan was launched by FDA in 2019 as a broad initiative to apply a more modern, tech-savvy approach to its regulatory directives. Updates include actively searching for innovations within its medical product application review process.
Announced in early 2021, the agency’s rollout of the Data Modernization Action Plan furthered its modernization mission by creating high-value driver projects within specific offices and throughout the agency as a whole.
The Data Modernization Action Plan provides a framework and recommendations for FDA’s Data Strategy. The plan consists of three directives:
- Identify and execute high-value driver projects for individual centers and for the Agency
- Develop consistent and repeatable data practices across the Agency
- Create and sustain a strong talent network combining internal strengths with key external partnerships
Orthopedic companies have seen these plans in action through FDA’s push to incorporate real-world evidence in product submissions and clinical follow-up, as well as its focus on cybersecurity and on artificial intelligence and machine learning.
Within FDA’s FY 2022 budget request was funding intended to further bolster data and IT updates through improvements that will be felt throughout the entire agency.
