The Food and Drug Administration is exploring a new federal contracting structure that aims to provide venture capital-backed startups with a more direct pathway to compete for agency work related to public health innovation.
Through a newly-issued request for information, venture capital firms are invited to comment on the proposed contract vehicle that would allow companies within an approved portfolio to compete for task orders supporting FDA missions, the agency said on Dec. 19. The approach is designed to reduce reliance on traditional prime contractors and speed access to emerging technologies.
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Why Is the FDA Rethinking Its Contracting Model?
Many high-impact technologies relevant to the FDA’s mission — including artificial intelligence, biotechnology, medical devices and regulatory technology — are being developed by early-stage companies that often struggle to engage with federal procurement processes.
The FDA cited structural barriers that tend to favor large systems integrators and labor-based contracts, limiting opportunities for scalable, product-driven solutions. The proposed model would address the problem by establishing direct contractual relationships with qualified venture capital firms, while treating portfolio companies as subcontractors.
What Is the FDA RFI Asking Industry to Provide?
The RFI seeks industry input on the structure of the potential contract vehicle. Topics include qualification standards for participating firms, intellectual property protections, compliance requirements and financial oversight mechanisms.
The FDA is particularly interested in how venture capital firms could function as prime contractors while ensuring portfolio companies meet federal acquisition and regulatory requirements.
Responses to the RFI are due by Jan. 18, 2026.
