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Success Of Case For Quality Program Triggers ‘Culture Shift’ At FDA's Device Center, Officials Say

CfQ VIP has pushed “CDRH to rethink how we do things across the whole spectrum of activities,” says the device center’s Vicenty

 
• By Shawn M. Schmitt

The US FDA’s Cisco Vicenty and Bleta Vuniqi say the Case for Quality Voluntary Improvement Program has shifted the culture at the agency’s Center for Devices and Radiological Health. That shift is “starting to … feed and percolate into other areas and other activities that the center’s been engaged in,” Vicenty says.

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Officials with the US Food and Drug Administration’s Center for Devices and Radiological Health say the success of a program that assesses a company’s manufacturing maturity and quality is causing a culture shift within the CDRH.

The Case for Quality Voluntary Improvement Program (CfQ VIP) – run jointly by the FDA and the Medical Device Innovation Consortium (MDIC) – aims to elevate product, manufacturing and process quality at device firms by appraising the companies against an industry-modified version of the Capability Maturity Model Integration (CMMI) framework

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