Per the notice below, the United States Food and Drug Administration (FDA) is highlighting its diagnostic data program.
The FDA's Diagnostic Data Program -- Advancing Data Harmonization, Quality, and Analytics.
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 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.
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Get Involved
We invite interested individuals to visit the website and learn more about opportunities to engage in these efforts, including applying for future funding. The FDA is also working with numerous stakeholders through the SHIELD Collaborative Community and encourages interested parties to engage in this effort.
Questions?
If you have questions about the FDA Diagnostic Data Program, reach out to:
DiagnosticDataProgram@fda.hhs.gov.
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