FDA center for devices and radiological health (cdrh) case for quality medical device information analysis and sharing strategic support

Ended Awarded Last action

Contract number
75F40121F80441
Awardee
Awarding agency
Obligated
$7,326,703

Award facts

Opportunity
  • 9152021 Solicitation number
Contract value 100% obligated
$7,326,703.14 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
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

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Close Out P00002 -$228,015
Other Administrative Action P00001 $0
Original award $7,554,718

About this award

The Food and Drug Administration's Center for Devices and Radiological Health awarded a delivery order valued at $7.3M to The Mitre Corporation for strategic support services focused on quality medical device information analysis and sharing. This cost-plus-fixed-fee delivery order, which commenced on September 27, 2021 and concluded on September 27, 2022, leverages Mitre's extensive capabilities as a non-profit Federally Funded Research and Development Center to support CDRH's mission of ensuring safe and effective medical devices. The work was performed in Silver Spring, Maryland, with Cedric Hanley serving as the Contracting Officer's Representative. This delivery order carries no set-aside designation, consistent with Mitre's status as a large FFRDC.

This delivery order likely issued under one of Mitre's established indefinite delivery vehicles, most notably its $2B single-award contract with the Centers for Medicare and Medicaid Services for the CMS Alliance to Modernize Healthcare FFRDC program, which has generated substantial delivery orders across HHS agencies including FDA, CMS, CDC, and the National Institutes of Health for healthcare system modernization and data analytics support. Mitre's demonstrated expertise in healthcare information systems, data strategy, quality measurement frameworks, and enterprise modernization positions it to deliver critical analytical and technical support for FDA's device regulation mission, complementing the agency's efforts to leverage data analytics for improved medical device oversight and stakeholder information sharing.

Quick answers

Who was awarded contract 75F40121F80441?

75F40121F80441 was awarded to The Mitre Corporation by Food and Drug Administration (Department of Health and Human Services) on September 27, 2021.

How much is contract 75F40121F80441 worth?

The government has obligated $7,326,703 on 75F40121F80441.

Is contract 75F40121F80441 an order under another contract?

Yes. 75F40121F80441 is a delivery order under 75FCMC18D0047, an indefinite delivery contract.

Was contract 75F40121F80441 competed?

The extent of competition for 75F40121F80441 was full and open competition.

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