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Globalisation creates unique regulatory challenges, says CDRH director

This article was originally published in RAJ Devices

Executive Summary

Though the US Food and Drug Administration is increasing the number of foreign inspections it carries out abroad, this is not the only answer to ensuring the safety of imported medical devices, says the director of the agency’s Center for Devices and Radiological Health. During a presentation at AdvaMed’s 2009 International Medical Device Industry Compliance, Regulatory and Intellectual Property Conference held in Rome, Italy, from 25-27 May, Daniel Schultz said that the globalisation of the medtech market had created “unique regulatory challenges” and, thus, the agency needed to find innovative ways to deal with them.

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