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CDRH Employee Surveillance Went Too Far, OIG, Lawmakers Say

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.

FDA went too far in the computer surveillance of five device center scientists beginning in 2010, according to a report from the HHS Office of Inspector General.

The OIG report details the roles of CDRH and FDA managers in setting up computer surveillance of select staffers believed to have disclosed proprietary device company information to the media. The report, released Feb

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• By Ashley Yeo

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First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

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• By Marion Webb

SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.