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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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The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on recent FDA proposals to streamline the 510(k) and PMA submission processes and the ongoing investigation into FDA surveillance of CDRH employee whistleblowers.

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In the latest turn of events for FDA, a federal judge has ordered the agency to hand over thousands of documents accumulated from monitoring employees’ communications.

Pressure Mounts On FDA After Public Release Of Surveillance Documents

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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