The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to describe its policy regarding FDA’s participation in the Voluntary Improvement Program (VIP).
The Voluntary Improvement Program (VIP) is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates 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.
The VIP builds on the framework piloted through FDA’s 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot.
The VIP is a third-party quality maturity appraisal and continuous improvement program, which was developed to improve medical device production and quality. The VIP is a voluntary program, not a regulatory requirement.
It reviews a participating manufacturer’s capability and performance in key business processes by having qualified, third-party appraisers visit participant firms to observe the firm’s practices.
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