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November 01 FDA's Device Adverse Events Database... Who Cares?Device group inefficiently uses adverse-event reports A new study from the HHS inspector general's office has found that while overall reporting of medical device adverse events increased significantly between 2003 and 2007, the Food and Drug Administration's Center for Devices and Radiological Health, or CDRH, has done an inadequate job of using those reports to detect and address product safety concerns.“We found that CDRH has not documented follow-up on adverse events, nor does it consistently read adverse-event reports for the first time in a timely manner,” wrote HHS spokesman Don White in an e-mail sent to reporters. “In addition, CDRH rarely acts when manufacturers and user facilities submit reports late.” TrackbacksThe trackback URL for this entry is: http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!1371.trak Weblogs that reference this entry
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