Award
Definitive Contract #75F40126C00064
Medical Device Innovation Consortium Awarded Contract for Real-World Data Infrastructure
Buyer
Food and Drug Administration
Award Amount
$6,000,000.00
Ceiling
$12,000,000.00
Awarded
September 30, 2026
Period of Performance
Sep 30, 2026 – Sep 29, 2027
Identifier
75F40126C00064
NAICS
541715
This definitive contract was awarded to The Medical Device Innovation Consortium, an organization focused on advancing medical device technologies, for the purpose of enhancing infrastructure related to Real-World Data (RWD) sources and Real-World Evidence (RWE) generation specifically for medical devices. The contract represents a significant investment in improving data capabilities that support medical device innovation and regulatory decision-making. The scope includes developing and improving systems and methodologies to better collect, analyze, and utilize real-world data to generate evidence that can inform medical device safety and effectiveness. This multi-year agreement is set to commence with an initial one-year performance period and includes an option to extend for an additional year, reflecting a long-term commitment to this critical area of healthcare technology advancement. The contract was competitively procured under a broad agency announcement aimed at enhancing RWD and RWE capabilities. The work will be performed in Arlington, Virginia, aligning with key industry and government personnel engaged in medical device innovation.
Description
EO 14398 - BAA - ENHANCING INFRASTRUCTURE FOR REAL-WORLD DATA (RWD) SOURCES AND REAL-WORLD EVIDENCE (RWE) GENERATION IN MEDICAL DEVICES