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Facility inspections and MedSun participation up, report says

This article was originally published in The Silver Sheet

Executive Summary

CDRH exceeded facility inspection goals last year by at least 20 percent, according to the center's annual report for fiscal year 2006. FDA conducted 1,299 domestic inspections (1,066 planned), as well as 207 foreign inspections (168 planned) and 336 bioresearch monitoring (BIMO) inspections (278 planned), the report states. CDRH Director Dan Schultz says in the report that the increased number of inspections is part of the center's enhanced "postmarket oversight to ensure the safety and effectiveness of products." The annual report also found that CDRH exceeded by 15 percent its 2006 goal of obtaining a 71 percent participation rate from the 350 hospitals participating in the Medical Product Surveillance Network (MedSun). Facilities enrolled in the program, which receive special training in adverse event reporting and agree to cooperate fully with agency reporting laws, are expected to provide accurate, detailed and thorough information on device adverse events ("The Silver Sheet" March 2005)





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