FDA Puts Finishing Touches On Draft Guidance To Set Case For Quality VIP Program In Stone
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.
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The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.
The US agency’s device center on 26 October published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including drafting guidances to transition emergency use authorized products to full marketing status, and finalizing a clinical decision support software guidance that’s been four years in the making.
From cutting costs to getting products to market faster, experts at the two companies explain why it pays to keep quality at the fore.