Maisel Reassumes Acting FDA Device-Evaluation Chief Role As John Sheets Departs
John Sheets is leaving US FDA after less than a year serving as director of the Office of Device Evaluation. As a result, Device-center Chief Scientist William Maisel has resumed his role as acting ODE director, a post he filled from 2014 to 2016 before Sheets was hired by the agency.
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Robin Newman is out as director of the Office of Compliance within US FDA's device center, leaving the post after only 18 months on the job. Agency stalwart Bill Maisel has taken her place on an "acting" basis as he leads the effort to create a "super office" that will merge the compliance office, the Office of Surveillance and Biometrics, and the Office of Device Evaluation into one.
Alberto Gutierrez left FDA and government this week in a planned retirement. He was director of the office that oversees pre- and post-market programs for in vitro diagnostics and radiology devices, an office where several holes already exist in top management slots.
Device industry veteran John Sheets has been appointed as the new director of FDA's premarket review office for devices. It’s the second time this year that CDRH has tapped an industry executive to lead one of its offices.