What Happens to Medical Device Reports Once They Reach FDA?

January 3, 2011

Ever wonder what happens to the thousands of medical device reports that are filed every month with FDA? Are they being put to good use?

In October 2009, the HHS Office of Inspector General(OIG) issued a report titled, “Adverse Event Reporting for Medical Devices. This report demonstrates that the current system of medical device adverse event reporting, particularly with regard to malfunction reports, could largely be considered a waste of industry and FDA resources.