FDA center for devices and radiological health (cdrh) digital health software precertification (pre-cert) pilot program COR: tiffany hart
Ended Awarded
- Contract number
- 75F40121F80090
- Awardee
-
The Mitre Corporation UEI DMHDNDCPWUD1 Part of The Mitre Corporation
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $1,870,630
Award facts
- Contract value 89% obligated
-
- $1,870,630.00 Current, with exercised options
- $2,105,231.00 Potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Set-aside
- No set-aside
- Competition
- Full and Open Competition Negotiated Proposal / Quote
- Pricing
- Cost Plus Fixed Fee
- Place of performance
- Silver Spring, MD 20993, 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
This is a delivery order awarded by the U.S. Food and Drug Administration (FDA) to The Mitre Corporation, a not-for-profit organization that operates federally funded research and development centers. The contract, valued at $2,105,231.00, is for the FDA Center for Devices and Radiological Health (CDRH) Digital Health Software Precertification (Pre-Cert) Pilot Program. The contract does not have a set-aside designation. As the prime contractor, Mitre will provide services related to this FDA initiative, which aims to develop a regulatory framework for the precertification of digital health software. Mitre has extensive experience supporting federal agencies across various domains, including national security, healthcare, and cybersecurity, through its technical expertise and partnerships with major subcontractors.
Quick answers
Who was awarded contract 75F40121F80090?
75F40121F80090 was awarded to The Mitre Corporation by Food and Drug Administration (Department of Health and Human Services) on March 29, 2021.
How much is contract 75F40121F80090 worth?
The government has obligated $1,870,630 on 75F40121F80090. Its potential value, with all options, is $2,105,231.
Is contract 75F40121F80090 an order under another contract?
Yes. 75F40121F80090 is a delivery order under 75FCMC18D0047, an indefinite delivery contract.
Was contract 75F40121F80090 competed?
The extent of competition for 75F40121F80090 was full and open competition.
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