Delivery Order HHSF223201400022I-HHSF22301008T

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...

This is a firm fixed-price BPA call contract awarded by the Food and Drug Administration (FDA) to Global Net Services, Inc. (Globalnet Services, Inc.) for CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) ELECTRONIC SUBMISSION (CESUB) STEADY STATE SUPPORT SERVICES. The contract has a ceiling value of $1,911,902.60 and a completion date of March 28, 2017. The contract was awarded on March 28, 2016 and is not a set-aside contract. The contract involves the provision of support services for the...

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...

The Department of Health and Human Services Office of the Assistant Secretary for Administration issued a delivery order to Accenture Federal Services LLC on July 2, 2018, under the HHS Program Support Center IDIQ for FDA CDRH business improvement initiatives, with a ceiling value of $5.186 million. Place of performance is Silver Spring, MD. The order, issued under a firm fixed price structure, supports the FY26 UDO Initiative and carries an ultimate completion date of September 3, 2023.

This delivery order, awarded on September 18, 2020, is part of a larger $103 million Indefinite Delivery Contract between the Food and Drug Administration (FDA) and Pn-Heitech, LLC, a minority-owned small business based in Baltimore, Maryland. The contract has a ceiling value of approximately $13.7 million and supports the Center for Devices and Radiological Health (CDRH) premarket and postmarket tracking services. The work will be performed in Rockville, Maryland, with an ultimate completion...

The Department of Health and Human Services Food and Drug Administration awarded a $4.9 million firm fixed price contract to Emergency Care Research Institute, doing business as Ecri, to conduct material performance study services for the Center for Devices and Radiological Health. Per the original solicitation, Ecri will systematically review scientific literature and patient safety organization databases to establish safety profiles for up to 50 commonly used materials in medical devices...

The Food and Drug Administration issued a delivery order to Emergint Technologies, LLC on September 14, 2012, with a ceiling value of $852,666.86 under an 8(a) sole source set-aside. Emergint Technologies is a subsidiary of CACI International Inc. Place of performance is Rockville, MD. The order carried an ultimate completion date of September 14, 2013 and was priced on a firm fixed price basis. The award description references FDA CFSAN CAERS support (OIM 12 DOS CFSAN CAERS 160), indicating...

The Food and Drug Administration (FDA) awarded a delivery order valued at approximately $2.0 million to Akima Data Management LLC on August 12, 2024, for the Enterprise Document and Record Management Platform (EDRMP) supporting the Center for Devices and Radiological Health (CDRH). This firm fixed-price contract is scheduled for completion by August 31, 2026, and will be performed in Herndon, Virginia. The award was made without a set-aside designation to Akima Data Management LLC, an...

The Food and Drug Administration issued a delivery order to Pn-Heitech, LLC, a HUBZone small business, on June 8, 2023, with a ceiling value of $432,948.96 under a labor-hour pricing structure for help desk services support to the Center for Devices and Radiological Health (CDRH). Place of performance is Silver Spring, MD. The order's ultimate completion date is May 31, 2025. The delivery order has been deobligated and closed out. Pn-Heitech is a minority-owned small business and...

The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) awarded a $134,380.12 firm fixed-price delivery order to Software Information Resource Corp. for nQuery Advanced Software enterprise licensing and maintenance support. This award represents the exercise of Option Period 3 under an existing contract vehicle, extending services through February 14, 2028. The delivery order was issued without a small business set-aside designation and is being performed under the...