Over the past year, the FDA's Diagnostic Data Program has made substantial progress toward harmonizing diagnostic data, enhancing data quality, and creating analytics tools to optimize data use.

Efforts include:  

• Working across the agency and with external stakeholders to improve the quality and utility of diagnostic data, as well as its flow between individuals and institutions who need it.
• Providing enhanced regulatory support and guidance to ensure that new and advanced diagnostic technologies will be safe, effective, and timely in their introduction to the U.S. market.
• Supporting projects with collaborating institutions and investigators including allocating approximately $100M to extramural teams for projects that advance the FDA’s mission and goals.
• Driving improvements in data quality from over-the-counter, point-of-care, and lab-based diagnostic tests that help inform patient care, population health, and regulatory decision-making.
• Developing a regulatory data sandbox to facilitate the development of analytical tools to support regulatory review, starting with specific use cases that integrate both new (e.g., real-world data) and traditional sources of data.