75F40126C00064
Definitive Contract
Overview
Government Description
EO 14398 - BAA - Enhancing infrastructure for real-world data (RWD) sources and real-world evidence (RWE) generation in medical devices. The contractor will perform tasks to advance scientific knowledge in regulatory science, including developing deliverables such as progress reports, final reports, software, and hardware. Work will adhere to industry-specific standards and be conducted at FDA-specified locations, including Silver Spring and Beltsville, Maryland.
Awarding / Funding Agency
Place of Performance
Arlington, VA 22209 United States
Pricing
Fixed Price
Set Aside
None
Extent Competed
Full And Open Competition
Est. Average FTE
29
Related Opportunity
Analysis Notes
Subcontracting Plan This Definitive Contract has an Individual Subcontract Plan. The Department of Health and Human Services has an overall small business subcontracting goal of 32%
The Medical Device Innovation Consortium was awarded
Definitive Contract 75F40126C00064 (75F401-26-C-00064)
for EO 14398 - BAA - Infrastructure for RWD and RWE in Medical Devices
worth up to $12,000,000
by the FDA Office of Acquisition and Grant Services
in September 2026.
The contract
has a duration of 2 years and
was awarded
through solicitation FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
full & open
with
NAICS 541715 and
PSC AN12
via direct negotiation acquisition procedures with 257 bids received.
As of today, the Definitive Contract has a total reported backlog of $6,000,000.
Status
(Open)
Last Modified 10/5/26
Period of Performance
9/30/26
Start Date
9/29/27
Current End Date
9/29/28
Potential End Date
Obligations and Backlog
$6.0M
Total Obligated
$6.0M
Current Award
$12.0M
Potential Award
$0.0
Funded Backlog
$6.0M
Total Backlog
Award Hierarchy
Definitive Contract
75F40126C00064
Subcontracts
Activity Timeline
Opportunity Lifecycle
Procurement history for 75F40126C00064
People
Suggested agency contacts for 75F40126C00064
Competition
Number of Bidders
257
Solicitation Procedures
Negotiated Proposal/Quote
Evaluated Preference
None
Performance Based Acquisition
Yes
Commercial Item Acquisition
Commercial Item
Simplified Procedures for Commercial Items
No
Other Categorizations
Subcontracting Plan
Individual Subcontract Plan
Cost Accounting Standards
Exempt
Business Size Determination
Large Business
Awardee UEI
EBVDJ7R7AY35
Awardee CAGE
70SF6
Agency Detail
Awarding Office
75F401 FDA OFFICE OF ACQ GRANT SVCS
Funding Office
75F401
Created By
hhscraig_wright
Last Modified By
hhscraig_wright
Approved By
hhsian_weiss
Legislative
Legislative Mandates
None Applicable
Performance District
VA-08
Senators
Mark Warner
Timothy Kaine
Timothy Kaine
Representative
Donald Beyer
Modified: 10/5/26