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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

Executive Summary

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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