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Ex-FDA Device Compliance Chief Steve Silverman Joins AdvaMed

Executive Summary

Steve Silverman, former director of compliance at FDA's device center, has moved from a consulting role at McKinsey & Co. to AdvaMed, where he will serve as VP of technology and regulatory affairs.

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CDRH Compliance Director Steven Silverman Departing

Online-Only Content >>> Steven Silverman is leaving FDA to pursue other opportunities outside of government. "I’ve never had a better job than my current one. Even so, I feel that it’s time for me to gain experience in other areas," said Silverman, who has not signaled what his next move will be.

CDRH Office Of Compliance Shifts To “Function-Based Structure”

FDA’s device center Office of Compliance is reorganizing. Major goals are to organize staff around functions rather than product categories, increase attention to underserved areas and strengthen the office’s international focus.

Root Cause Analysis A Key Element Of FDA’s ‘Case For Quality’

CDRH is highlighting poor root cause analysis as part of its “Case for Quality,” an initiative that encourages companies to make quality assurance an organization-wide concern. Since FDA directed firms in 2009 to write FDA-483 response letters within 15 workdays after an inspection, the agency has been concerned that companies might feel compelled to fix every citation listed on the inspection form quickly without considering root causes. “What we are worried about is that this perceived need to respond in such a manner may prevent firms from taking time for a greater root cause assessment of the systemic problems that gave rise to the FDA-483 citations,” CDRH Office of Compliance Director Steven Silverman said. The Case for Quality will also examine how companies are inspected and how to make device quality data more accessible to firms.

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