FDA Modernization in Action 2022

Technology and data have disrupted our world in ways unimaginable only 20 years ago – including how the world thinks about health. The COVID-19 pandemic only accelerated this change and underscored the importance of aligning technology and data strategies to drive positive outcomes in our critical work addressing public health challenges. From how we integrate new technology into medical product applications reviews and food safety, to using to data insights to help treat disease, technology and data are ubiquitous to the FDA’s work. 

In September 2019 the FDA released the Agency’s Technology Modernization Action Plan (TMAP), followed in March 2021 by the release of the Data Modernization Action Plan (DMAP). The plans shared the FDA’s vision for technology and data modernization to advance the Agency’s mission:
 

Modernization in Action 2022 (PDF)

TMAP’s three areas of focus include modernizing the FDA’s technical infrastructure and operations; enhancing the FDA’s capabilities to develop technology products; and communication and collaboration with external stakeholders to drive technological progress that is interoperable and delivers value to consumers and patients. 

DMAP outlined three key objectives, including identifying and executing high-value, scalable driver projects for the FDA and individual FDA Centers; developing consistent and repeatable data practices across the Agency; and creating and sustaining a strong talent network combining internal strengths with key external partnerships. 

Also, check out our FDA Voices Blog for more information.

Importantly, in September 2021, the FDA completed a strategic reorganization to form the Office of Digital Transformation (ODT). Reporting directly to the FDA Commissioner, ODT provides high quality, secure, and efficient IT and data solutions that enable the FDA to promote and protect the public health. TMAP and DMAP are central to ODT’s work. 

As we mark the one-year anniversary of DMAP, and nearly three years since launching TMAP, we are pleased to provide an update on our progress with the Modernization in Action 2022 report. TMAP and DMAP have provided important frameworks for the FDA’s modernization over the past three years. Our continued journey will increasingly focus on integration into all aspects of FDA operations in support of cross-agency initiatives to optimize shared business processes. These efforts will enhance operational efficiency and use of our data, while strengthening the alignment between Agency-wide strategic objectives and investments.