FDA explores contracting model with venture capital firms

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The FDA is exploring a new contracting model that would allow venture capital firms to help facilitate partnerships between the agency and technology startups.

The agency issued a request for information Dec. 19 seeking input from venture capital firms on establishing direct relationships, which would allow companies in their portfolios to compete for and receive task orders. The model aims to reduce the agency’s reliance on large federal contractors and address barriers that limit engagement with technology startups developing AI, medical devices, regulatory tools and biotechnology solutions.

The FDA cited limitations in current federal contracting mechanisms, which often favor large systems integrators and labor-based vendors. It also raised concerns about accessibility and the misuse of small business set-aside programs.

The agency is requesting feedback on topics including qualification criteria, financial and administrative considerations, intellectual property protections and regulatory compliance frameworks. Responses are due Jan. 18, 2026.

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