CDRH Spyware Suit: Whistleblowers Sue Agency Over Email Surveillance
This article was originally published in The Gray Sheet
Six current and former employees of FDA’s device center file suit in the U.S. District Court in Washington, D.C., arguing that email and computer surveillance violated their constitutional and legal whistleblower rights.
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During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.
FDA may have had legitimate concerns that confidential commercial information on a GE Healthcare 510(k) submission were released in 2010 by CDRH scientists, but the agency’s computer monitoring strategy lacked sufficient controls, and may have gone beyond legal bounds, suggests the HHS Office of Inspector General. The agency issued a new interim monitoring policy last September that addresses OIG’s recommendations.
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