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AdvaMed wants full recognition of ISO 13485

This article was originally published in The Silver Sheet

Executive Summary

Device trade association AdvaMed is urging FDA to move more quickly to fully recognize ISO 13485, the international quality system standard for medical device manufacturing. "We believe it would be good ... for FDA to recognize ISO 13485 because companies operate in a global environment," Janet Trunzo, AdvaMed's executive VP of technology and regulatory affairs, told "The Silver Sheet." "Because quality system management programs are such an integral part of medical device manufacturing, the safety and effectiveness of medical devices is not dependent on FDA and the frequency of FDA inspections," she said. Inspections are "a core function of FDA, but the quality management systems and compliance to ISO 13485 ... also is a very important part of a company's programs." ISO 13485's requirements for firms are not identical to the Quality System Regulation, although the two regimes are "95 percent alike," Trunzo noted. The agency recently released a draft guidance that would allow the results of ISO inspections to be a factor in FDA's decision whether to conduct its own inspections ("The Silver Sheet" June 2010)

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