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14 January 2015
by Alexander Gaffney, RAC

CDRH Compliance Director Silverman Leaving FDA

The longtime director of the Center for Devices and Radiological Health's (CDRH) Office of Compliance, Steve Silverman, plans to leave the US Food and Drug Administration (FDA) next week to pursue other opportunities, press officials have confirmed to Regulatory Focus.

Silverman has been a central figure in CDRH's "Case for Quality," an effort to improve compliance among medical device manufacturers by focusing on common quality errors across the device industry. "We are consistently seeing a high volume of the same issues year after year," he noted in a 2013 presentation on the subject.

Silverman will be succeeded on an interim basis by Jan Welch, who now serves as the deputy director for Regulatory Affairs in CDRH's Office of Compliance. A search for a permanent successor to Silverman is now underway, FDA press official Jenny Haliski told Focus.