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IDIQ for Advanced Manufacturing and Quality Efforts

Forecast

Federal

Contract Overview

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AI Contract Overview

The Food and Drug Administration is establishing an Indefinite Delivery Indefinite Quantity contract for Advanced Manufacturing and Quality Efforts to support the Center for Devices and Radiological Health Case for Quality program. This initiative aims to identify medical device manufacturers that consistently maintain high quality standards, allowing the agency to optimize resource allocation and promote industry best practices. By aligning regulatory and enforcement approaches with high-performing manufacturing processes, the program seeks to enhance the overall quality of medical devices. The program is supported by the Voluntary Improvement Program, which is facilitated through the Medical Device Innovation Consortium. This component utilizes third-party appraisals to evaluate the capability and performance of a manufacturer's business processes against integrated best practices. This forecast is categorized under NAICS code 541990 and serves as a mechanism to guide industry participants toward continuous quality improvement.

General Info

FDA IDIQ contract for medical device advanced manufacturing and quality improvement efforts.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541990 - All Other Professional, Scientific, and Technical Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.