FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program
The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
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The US FDA is teaming up with the Medical Device Innovation Consortium to establish the clearinghouse, which would nudge medtech companies to adopt novel approaches that could take their manufacturing operations to a higher level.
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The goal of the guidance is to make the Case for Quality Voluntary Improvement Program, or CfQ VIP, “more official” at the US FDA, an agency official says. CfQ VIP aims to elevate product, manufacturing and process quality at medical device firms.