Food and drug administration (FDA) center for radiological health (cdrh) risk analysis of emerging technologies for medical device safety COR: karina kuhn

Ended Awarded Last action

Contract number
75F40124F80325
Awardee
Awarding agency
Obligated
$417,733

Award facts

Contract value 100% obligated
$417,733.00 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Set-aside
No set-aside
Competition
Not Competed Only One Source
Pricing
Cost Plus Fixed Fee
Place of performance
Silver Spring, MD 20993, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Supplemental Agreement for work within scope P00005 $0
Supplemental Agreement for work within scope P00004 · Extend POP - food and drug administration (FDA) center for radiological health (cdrh) risk analysis of emerging technologies for medical device safety $0
Other Administrative Action P00003 · COR change - food and drug administration (FDA) center for radiological health (cdrh) risk analysis of emerging technologies for medical device safety $0
Other Administrative Action P00002 $0
Supplemental Agreement for work within scope P00001 $0
Original award $417,733

About this award

The Food and Drug Administration's Center for Radiological Health awarded a delivery order to The Mitre Corporation valued at $417,733 on September 19, 2024, for risk analysis of emerging technologies for medical device safety. This cost-plus-fixed-fee contract, which requires Cost of Contracting and Cost of Services approval, extends through December 31, 2025, and will be performed in Silver Spring, Maryland. The engagement represents an extension of the period of performance for Mitre's ongoing work supporting the FDA's efforts to evaluate and assess safety risks associated with new and emerging medical device technologies.

This delivery order is issued under a larger indefinite delivery vehicle, indicating Mitre's established role as a trusted technical partner to the FDA. As a federally funded research and development center, Mitre provides scientific and technical support across multiple federal agencies, with particular expertise in systems engineering, data analytics, and technology assessment. The contract carries no set-aside designation, consistent with Mitre's status as a large non-profit organization. Through this engagement, Mitre will continue delivering analytical and research capabilities to help the FDA manage regulatory challenges posed by innovative medical device technologies.

Quick answers

Who was awarded contract 75F40124F80325?

75F40124F80325 was awarded to The Mitre Corporation by Food and Drug Administration (Department of Health and Human Services) on September 19, 2024.

How much is contract 75F40124F80325 worth?

The government has obligated $417,733 on 75F40124F80325.

Is contract 75F40124F80325 an order under another contract?

Yes. 75F40124F80325 is a delivery order under 75FCMC23D0004, an indefinite delivery contract.

Was contract 75F40124F80325 competed?

The extent of competition for 75F40124F80325 was not competed.

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