EO 14398 - BAA - enhancing infrastructure for real-world data (RWD) sources and real-world evidence (RWE) generation in medical devices
Active Definitive Contract Awarded Last action
- Contract number
- 75F40126C00064
- Awardee
-
The Medical Device Innovation Consortium UEI EBVDJ7R7AY35
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $6,000,000
Award facts
- Opportunity
-
- FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Special Notice · FDABAA2600123 · Posted Nov 21, 2025
- Contract value 50% obligated
-
- $6,000,000.00 Current, with exercised options
- $12,000,000.00 Potential, with all options
- Completion date 4% complete
-
- Current, with exercised options
- Potential, with all options
- Contracting staff
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Negotiated Proposal / Quote
- Pricing
- Firm Fixed Price
- Place of performance
- Arlington, VA 22209, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
About this award
The Food and Drug Administration awarded a $12 million definitive contract to The Medical Device Innovation Consortium on September 30, 2026, to enhance infrastructure for real-world data sources and real-world evidence generation in medical devices under Executive Order 14398, with completion by September 29, 2028.
The originating solicitation is the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science, a competitive special notice posted November 21, 2025, seeking basic and applied research and development proposals to advance regulatory science and innovation. The BAA encompasses three charge areas: modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. Proposals responded to research priority areas including new approach methodologies, advanced manufacturing, analytical and computational methods, biomarkers, clinical outcome assessments, and emerging technologies. Place of performance is Arlington, VA. The contract is firm fixed price with no set-aside applied. The awardee is a non-profit organization and operates as a prime contractor without subcontractors. Government-paid hourly rates on comparable SCI-reportable work range from $120.08 to $200.70 per hour, with a median of $200.70. The awardee's recent federal invoiced revenue on service contracts above the $150,000 threshold totaled $5.6 million in FY2024, delivered by approximately 7 to 8 FTEs. The organization's portfolio is concentrated exclusively with the FDA across regulatory science and device quality and safety services.
Quick answers
Who was awarded contract 75F40126C00064?
75F40126C00064 was awarded to The Medical Device Innovation Consortium by Food and Drug Administration (Department of Health and Human Services) on September 30, 2026.
How much is contract 75F40126C00064 worth?
The government has obligated $6,000,000 on 75F40126C00064. Its potential value, with all options, is $12,000,000.
Was contract 75F40126C00064 competed?
The extent of competition for 75F40126C00064 was full and open competition. The government received 1 offer.
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