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FDA faulted for oversight of foreign medical device and drug makers.

Publication: Trial
Publication Date: 01-AUG-08 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
This year's heparin recalls, as well as Government Accountability Office (GAO) investigations of medical device manufacturers, have shown that the FDA has some serious oversight problems with foreign manufacturers.

The FDA has difficulty managing its program to inspect foreign establishments that make medical devices, according to GAO testimony before the House Subcommittee on Health at a May hearing. (FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments, GAO-08-780T (May 2008).)

The agency lacks accurate data on the number of device manufacturers it should inspect, and it actually inspects relatively few foreign sites where medical devices are made for the U.S. market, reported Marcia Crosse,...

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