Pathways for Regulatory Innovation and Strategic Modernization (PRISM)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you've built tools, platforms, or methods that help FDA or industry understand and navigate emerging medical technologies faster, PRISM funds the science and collaboration infrastructure to scale that impact.
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What this is
PRISM is an FDA-led initiative providing up to $1.3M to support forward-looking collaborations that strengthen the scientific and operational foundations of modern regulatory oversight. The program seeks to bridge gaps between innovation and regulation by leveraging independent expertise, real-world data, and multi-stakeholder engagement (patients, consumers, industry, academia, healthcare). This is not a traditional grant for product development but rather funding for applied scientific work, tools, and knowledge-generation that improve regulatory predictability, efficiency, and transparency in an evolving medical product landscape.
Who can apply
Eligible applicant types are flexible (see Additional Information section in full RFP for specifics); generally includes for-profit companies, non-profits, academic institutions, and consortia. Domestic organizations and those with meaningful FDA engagement are typically preferred. Geography: U.S.-based applicants.
Eligible applicant types
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
Full description — from the agency
The Pathways for Regulatory Innovation and Strategic Modernization (PRISM) cooperative agreement is intended to advance public health by strengthening the scientific, collaborative, and operational foundations needed to modernize regulatory oversight in an increasingly complex and rapidly evolving public health landscape. As innovation in medical products, diagnostics, foods, and digital health accelerates, our nation must continuously adapt its regulatory science approaches to ensure timely access to safe, effective, and high-quality products for the American public. PRISM is designed to support this modernization by enabling forward-looking, non-regulatory collaborations that align with the Commissioner’s strategic priorities and the Administration’s broader public health goals. PRISM provides a flexible, scalable approach to patient, consumer, industry, academia, and healthcare workforce engagement to generate applied scientific knowledge, tools, and approaches that enhance regulatory predictability, efficiency, and transparency. By leveraging independent expertise and real-world insights, PRISM bridges gaps between innovation and regulation to optimize uptake of emerging technologies, evolving consumer needs, and new sources of evidence such as real-world data and real-world evidence.
Topics: regulatory science · fda modernization · real-world evidence · digital health · medical device regulation · cooperative agreement
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.