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FDA Head to Look at Medical Device Safety
June 17, 2009
NEWSInferno.com
New U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg says she is working toward earlier safety warnings to doctors as well as resolving some of the issues with the agency’s medical device division, reports The Wall Street Journal.
“There obviously have been some problems,” said Dr. Hamburg in an interview discussing the agency’s Center for Devices and Radiological Health, calling it “a high priority,” quoted the Journal. At the time President Obama named Dr. Hamburg as his pick to head the FDA, she announced plans to overhaul the ailing agency and restore confidence in the FDA, said the Journal previously....
Earlier this year we reported that, according to the Project on Government Oversight, the Center for Devices and Radiological Health allows manufacturers and testing facilities to monitor their own compliance with federal regulations meant to ensure the safety of medical devices and that the FDA ignored federal Good Laboratory Practice regulations, a decision it called” stunning in its contempt for the protection of patients and its indifference to standards that comply with federal regulations.” Just prior, the Government Accountability Office issued a report that criticized the agency for failing to conduct appropriate medical device reviews.
