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It's Official: Jeffrey Shuren Is New Device Center Director

This article was originally published in The Gray Sheet

Executive Summary

FDA and Jeffrey Shuren have made it official: the neurologist, lawyer and experienced FDA staffer was named director of the agency's Center for Devices and Radiological Health Jan. 20

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Schultz the consultant: Former CDRH Director Daniel Schultz has joined Greenleaf Health as senior VP for medical devices and combination products, the consulting firm announced Jan. 6. Schultz left the device center in August as the new FDA leadership reassessed past CDRH device review practices, which have come under intensifying public criticism (1"The Gray Sheet" Aug. 17, 2009). He had led the center for five years and worked at CDRH for 15 years. Greenleaf is developing into a regular landing spot for recently departed top FDA officials. Taryn Fritz Warpole, former deputy chief of staff, joined the firm in July and former Commissioner Andrew von Eschenbach signed on as a senior advisor in March (2"The Gray Sheet" March 9, 2009). Former FDA Chief of Staff Patrick Ronan founded the consulting practice

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Acting device center director Jeffrey Shuren is vying to head the center permanently. He announced his candidacy to agency staff last week, according to Principal Deputy FDA Commissioner Joshua Sharfstein

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An internal evaluation of FDA's handling of the controversial 510(k) clearance of a knee implant unearthed serious shortcomings in the integrity of the agency's review process, FDA said Sept. 24

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