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Staff switches at FDA's device center

This article was originally published in The Silver Sheet

Executive Summary

CDRH has experienced a heavy dose of staff reorganization this year, with more than 40 upper-level moves since January. The Office of Device Evaluation (ODE) in June brought in Ginette Michaud from its division of anesthesiology, general hospital, infection control and dental devices to serve as acting clinical deputy director. Michaud replaces Aron Yustein, on detail to the Office of Surveillance and Biometrics (OSB) since February. Former Division of Enforcement B deputy director Christy Foreman is the new acting deputy director for science and review policy at ODE, and Barbara Zimmerman is the ODE acting associate director, replacing Robert Gatling. Gatling will permanently head up the ODE program operations staff, which freed Heather Rosecrans to return to her post as director of the 510(k) section. Meanwhile, former Office of Compliance staffer Nicole Wolanski replaced Samie Allen in May as PMA section director. And in mid-June, Ashley Boam left ODE's central office to return to her spot as chief of the interventional cardiology devices branch within the Division of Cardiovascular Devices. Further, the cardiovascular division named Mitchell Shein acting chief of the pacing, defibrillator and leads branch, after Megan Moynahan left in January to lead the Cardiac Electrophysiology and Monitoring Network in the Office of the Center Director
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