FOUNDATIONAL INNOVATION AND RAPID ENGAGEMENT (FIRE)

The U.S. Food and Drug Administration (FDA) is seeking information from Venture Capital (VC) firms regarding their interest in and requirements for a novel contract vehicle that would enable portfolio companies to compete directly for FDA contracts and task orders.

The FDA recognizes that many breakthrough technologies and innovative solutions relevant to our public health mission are being developed by companies within VC portfolios. These companies often possess cutting-edge capabilities in areas such as artificial intelligence, biotechnology, medical devices, and regulatory technology that could significantly benefit FDA operations and the broader public health ecosystem.

Historically, the FDA's engagement with startup and emerging technology companies has been constrained or limited due to:

Utilization of pass-through organizations or prime contractors, which can create barriers to direct engagement and limit scalability. Furthermore, disincentives often exist such that prime contractors focus on increasing labor-based work instead of scaling technologies.

Navigation of a complex federal bureaucracy that may be prohibitive for innovative firms focused on product development. It takes small and innovative companies a lot of dedicated time, energy, and funding to provide products and services to the government.