IDIQ for Advanced Manufacturing and Quality Efforts
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $700,000 to $1,500,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is procuring an indefinite-delivery, indefinite-quantity contract for advanced manufacturing and quality efforts supporting the Case for Quality program, with an estimated solicitation release on January 1, 2027, and award targeted for September 1, 2027. The contract will support evaluation of medical device manufacturers' quality practices and capabilities through third-party appraisals facilitated by the Medical Device Innovation Consortium's Voluntary Improvement Program, enabling CDRH to identify high-performing manufacturers and promote consistent quality manufacturing practices across the industry.
The estimated award value range is $700,000 to $1.5 million. Work falls under NAICS 541990 (All Other Professional, Scientific, and Technical Services). Inquiries should be directed to the FDA's CDRH acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
The CDRH has launched the Case for Quality (CfQ) program in order to better fulfill its mission through efficient regulatory pathways. The CfQ allows the CDRH to identify device manufacturers that consistently produce high quality devices. By doing so, CDRH can better focus their resources helping other manufacturers raise their level of quality. This program also helps CDRH identify and promote practices that support consistent quality manufacturing, and align our regulatory, enforcement, compliance approaches with those practices. The Voluntary Improvement Program (VIP) is facilitated through the Medical Device Innovation Consortium (MDIC) and supports CfQ by evaluating the capability and performance of a medical device manufacturer's practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices. VIP oversees third-party appraisers who evaluate voluntary industry participants and assesses the capability and performance of key business processes using a series of integrated best practices.
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