Delivery Order 75F40122D00019-75F40126F19004
- Not listed
- The Department of Health and Human Services Food and Drug Administration awarded a $7.4 million firm fixed price delivery order contract to the Medical Device Innovation Consortium, doing business as Mdic, with a period of performance from September 22, 2022 through September 22, 2024. The contract is to strengthen device quality and patient safety initiatives through continued support of Center for Devices and Radiological Health Quality Projects. Mdic will provide services and products to...
- The Department of Health and Human Services Food and Drug Administration awarded a $680,071 firm fixed price delivery order contract to the Medical Device Innovation Consortium, doing business as MDIC, to provide training materials for education around device innovation, particularly for training device sponsor applicants. The training materials are required for sponsors entering the device innovation space and will be delivered from MDIC's offices in Silver Spring, Maryland over a one year...
- The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $2,428,879 firm fixed price delivery order contract to The Medical Device Innovation Consortium - doing business as MDIC. The two-year contract, with a place of performance in Silver Spring, Maryland, is for EXTERNAL QUALITY & CONTINUOUS IMPROVEMENT PROGRAM services starting on September 6, 2022 through completion on September 5, 2024. MDIC will provide quality improvement and continuous...
- 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...
- The Food and Drug Administration awarded a $222,656 definitive firm fixed-price contract to Digital Medicine Society Inc. on January 15, 2025, under BAA FY24C1IP4 to expand patient-generated health data training capabilities within the Center for Devices and Radiological Health (CDRH). The contract, which carries an ultimate completion date of April 17, 2025, will be performed in Boston, Massachusetts, where the awardee is headquartered. This procurement was conducted through open competition...
- The Food and Drug Administration (FDA) awarded a $332.9K definitive contract to The Milken Institute on September 10, 2024, to define the value and return on investment of patient engagement in medical technology product development. The contract, issued under BAA-FY24C1IP3, carries a firm fixed price structure with no set-aside designation and is scheduled for completion by March 31, 2026. The work will be performed at The Milken Institute's Silver Spring, Maryland location, leveraging the...
- This is a cost-plus-fixed-fee delivery order contract awarded by the Food and Drug Administration (FDA) to The Mitre Corporation, a non-profit research organization, valued at $9,824,137.00. The contract is for the FDA Center for Devices and Radiological Health's (CDRH) Resilient Supply Chain and Shortages Prevention Program, which does not have a set-aside designation. Mitre will provide services such as systems engineering, data analytics, and organizational development to support the CDRH's...
- 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...
- This is a 1.5-year, Time-and-Materials (T&M) task order awarded to Pn-Heitech, LLC, a minority-owned small business, to provide acquisition and management of medical device adverse event data services to support the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). The task order has a ceiling value of $12,836,604.29 and was awarded on September 18, 2025, with an ultimate completion date of March 13, 2027. Pn-Heitech, LLC is a small disadvantaged...
- This is a task order awarded by the Food and Drug Administration (FDA) to Digim Solution LLC, a minority-owned small business, under an indefinite-delivery, indefinite-quantity (IDIQ) contract. The task order is for 3D microscopy, AI-based quantification, and modeling to support non-clinical evaluation and regulatory submissions for complex injectable and insertable drug products. The task order has a firm fixed price of $360,000.00 and a period of performance through March 9, 2026. Digim...
- 75F40122D00019Indefinite Delivery Contract
- 75F40122D00019-75F40126F19004Delivery Order
The Food and Drug Administration (FDA) awarded a delivery order valued at $1,009,892 to The Medical Device Innovation Consortium (MDIC) on January 28, 2026, to provide support for medical device innovation and regulatory science initiatives. This firm fixed-price delivery order, which is not set aside for small business, will be performed in Rosslyn, Virginia and is scheduled for completion by February 22, 2028. MDIC is a non-profit organization specializing in advancing regulatory science for medical devices through public-private partnerships designed to promote device innovation and quality improvements that enhance patient outcomes. This delivery order is issued under MDIC's larger $63 million indefinite delivery contract with the FDA's Center for Devices and Radiological Health. MDIC has previously received multiple delivery orders under this vehicle totaling over $12 million to support various FDA quality initiatives, including training materials for device sponsors on regulatory requirements, quality and continuous improvement program services, and quality projects through 2024. The company's established track record with the FDA positions it to continue delivering critical support for device quality and safety initiatives that align with the agency's mission to protect and promote public health.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | Not listed | $713.8k | 1/28/26 |