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In-Depth With CDRH Compliance Chief: Jan Welch Trumpets 'Case For Quality,' Urges Feedback From Manufacturers

This article was originally published in The Gray Sheet

Executive Summary

This "Silver Sheet"/"Gray Sheet" Q&A with Jan Welch, interim director of CDRH's Office of Compliance, offers a glimpse into current device center thinking on various activities such as FDA's "Case for Quality." She also warns device manufacturers that if they don't speak up, some issues of importance to them could end up on the back burner. And: Is Welch interested in the job full time?

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