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# FDA Releases Tech Modernization Plan
- URL: https://www.fdaweb.com/fda-releases-tech-modernization-plan/
- Published: 2019-09-18T12:00:00.000Z
- Updated: 2026-09-15T01:50:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145040

FDA has released its long-awaited [Technology Modernization Action Plan ](https://www.fda.gov/media/130883/download?ref=fdaweb.com)(TMAP) that describes short-term actions it is taking to modernize technology use — computer hardware, software, data, and analytics. The plan has three elements: **(1)** modernizing FDA’s technical infrastructure; **(2)** enhancing its capabilities to develop technology products to support its regulatory mission; and **(3)** communicating and collaborating with stakeholders to drive technological progress.

The TMAP begins with a technological foundation for developing FDA’s ongoing strategy around data itself, which it describes as “a strategy for the stewardship, security, quality control, analysis, and real-time use of data that will accelerate the path to better therapeutic and diagnostic options for patients and clinical care providers, and better tools to enhance and promote public health.”

As part of the plan’s focus on short-term modernization in computer hardware and software technologies, FDA says its infrastructure will need to “securely receive, store, exchange, link, and analyze data; careful attention to data quality, integrity and security; analyses-at-scale including real-time dashboards, blockchain, appropriate strategies for both structured and unstructured data, and artificial intelligence; and a learning culture that continuously builds on prior knowledge... Foundational requirements for a modern FDA technology infrastructure include virtual data storage (the cloud), problem-specific software development, and solutions for efficiently exchanging data.”

The plan says that as FDA applies more advanced technologies to its work, stakeholders can “explore new ways of developing FDA-regulated products and new methods of generating data to inform the regulation of those products. We must define our technical interfaces and data exchange protocols — this clarity from FDA will support broader efficiencies in communication and data exchange among the broader biomedical and health care community.”

As an example of FDA’s need to modernize its IT, the agency says it is building the “scientific and policy infrastructure to support increasing use of real-world evidence to support regulatory decisions... Sophisticated data collection and analysis are also reshaping clinical trials, offering the ability to make clinical trial data more efficient to collect and more representative of diverse patient populations. Novel and rapidly evolving technologies also promise to enhance the generation of evidence where the size of a clinical trial is limited — for instance, in the context of a rare disease. These technologies will also give FDA sensitive new tools for detecting safety issues, allowing rapid and targeted response.”