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CDRH Staffers To Obama: House Cleaning Urgent At Device Center

This article was originally published in The Gray Sheet

Executive Summary

The next FDA commissioner should seek resignations from all current device center managers, a group of CDRH scientists and physicians says in a Jan. 7 1letter to John Podesta, chief of President-elect Barack Obama's transition team

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Multiple investigations and lawsuits have opened in response to the matter, with more potentially to come. Some worry the intensifying issue has serious implications for the quality of the device center’s output.

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