Newman Out As CDRH Compliance Chief, Maisel In As Acting Director
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.
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Timothy Stenzel brings experience developing and commercializing new molecular diagnostics, including companion tests, and running a clinical laboratory to his new role as director of US FDA's Office of In Vitro Diagnostics and Radiological Health.
'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover
CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.
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.