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Shuren: Tensions between reviewers, ODE management led to branch move

This article was originally published in The Silver Sheet

Executive Summary

When FDA's device center moved its Radiological Devices Branch from the Office of Device Evaluation (ODE) to the Office of In Vitro Diagnostics Device Evaluation and Safety (OIVD) in January, CDRH portrayed the primary rationale as alignment of activities for diagnostics-focused devices under one roof ("The Silver Sheet" February 2010). However, during a June 22 FDA "town hall" meeting in Woburn, Mass., CDRH Director Jeffrey Shuren said severe tensions between radiological device reviewers and ODE management were mainly behind the change. Staffers in the Radiological Devices Branch had accused ODE management of pressuring reviewers to modify scientific evaluations, charges that became public in 2008 and 2009 after letters from some reviewers were sent to Capitol Hill and the Obama administration. The allegations of criminal conduct were referred to the Health and Human Services Office of Inspector General, which found no evidence of wrongdoing. "People had a fear of retaliation. There was uniform agreement by both the staff and management for [the] change," Shuren said

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