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CDRH hopes to rely more on foreign inspection reports

This article was originally published in The Silver Sheet

Executive Summary

Increasing the number of foreign device facility inspections alone will not dramatically improve FDA import safety; rather, the agency must rely more on foreign regulatory authorities to certify the safety and effectiveness of products made in their own countries, an FDA official says. "If you ask [Congress] what the problem is, the problem is not enough inspections," CDRH Director Dan Schultz said May 26 at an industry meeting in Rome. FDA is gradually increasing the number of foreign inspections it performs, he said, but doing so "is obviously very expensive and very time-consuming, and requires a lot of resources. The key is, we can't inspect our way out of this problem." Schultz said FDA will need to make better use of inspection reports and other work done by foreign authorities. In January 2008, the Government Accountability Office reported that FDA inspected only about 5 percent of foreign Class II and III device manufacturing facilities in the previous few years ("The Silver Sheet" February 2008). For at least a year now, CDRH has been considering whether to accept foreign ISO 13485 quality audits in lieu of its own inspections of foreign device firms as a way to stretch its foreign inspection resources ("The Silver Sheet" December 2008)
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