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CDRH Employee Surveillance Went Too Far, OIG, Lawmakers Say

This article was originally published in The Gray Sheet

Executive Summary

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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