IDIQ for Advanced Manufacturing and Quality Efforts

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.

Estimated value

>= $700K and < $1.5M

Est. solicitation date

Jan 1, 2027

Anticipated award

Sep 1, 2027

• NAICS541990
• PSC541990