Time and materials award center for devices and radiological health (cdrh)- medical device reporting (MDR) FDA three-way-matching invoice clause-COR
Ended Awarded Last action
- Contract number
- 75F40120F19002
- Awardee
-
Pn-Heitech, LLC UEI G9G7WDSAAMM3
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $34,624,138
Award facts
- Contract value 100% obligated
- $34,624,137.73 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- NAICS code
- 541611 Administrative Management and General Management Consulting Services
- Set-aside
- No set-aside
- Competition
- Full and Open Competition after exclusion of sources Negotiated Proposal / Quote
- Pricing
- Time and Materials
- Place of performance
- Rockville, MD 20857, USA
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Exercise an Option | $8,072,788 | |
| Other Administrative Action | $0 | |
| Exercise an Option | $9,174,526 | |
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Other Administrative Action | $223,699 | |
| Other Administrative Action | $0 | |
| Exercise an Option | $6,683,263 | |
| Exercise an Option | $5,496,716 | |
| Other Administrative Action | $22,042 | |
| Original award | $4,951,103 |
Show all 14
About this award
The Food and Drug Administration's Center for Devices and Radiological Health awarded a time and materials delivery order to Pn-Heitech, LLC, a minority-owned small business and self-certified small disadvantaged business based in Baltimore, Maryland. The contract, valued at approximately $34.6 million, supports the Medical Device Reporting program and includes a three-way matching invoice clause. Performance will be conducted in Rockville, Maryland, with an ultimate completion date of September 29, 2025. No set-aside designation was applied to this award. The contracting officers of record are David McClintock and Aura McClain, with Kimberly W. Davis serving as the contract specialist.
This delivery order represents one of multiple task orders that Pn-Heitech has received under a $103 million indefinite delivery contract with the FDA. The contractor provides comprehensive information technology, regulatory support, and administrative services with a focus on the FDA's device centers. Services under this delivery order encompass medical device adverse event data management and related postmarket activities in support of CDRH's Medical Device Reporting function, which is critical to FDA's mission of ensuring the safety and effectiveness of medical devices in the marketplace.
Quick answers
Who was awarded contract 75F40120F19002?
75F40120F19002 was awarded to Pn-Heitech, LLC by Food and Drug Administration (Department of Health and Human Services) on September 28, 2020.
How much is contract 75F40120F19002 worth?
The government has obligated $34,624,138 on 75F40120F19002.
Is contract 75F40120F19002 an order under another contract?
Yes. 75F40120F19002 is a delivery order under 75F40120D00020, an indefinite delivery contract.
Was contract 75F40120F19002 competed?
The extent of competition for 75F40120F19002 was full and open competition after exclusion of sources.
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