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Exciting but uncertain times for medtech regulation

This article was originally published in Clinica

Executive Summary

Jeffrey Shuren really shouldn't have implied that the regulatory system for medical devices in the EU allowed patients to be used as guinea pigs. But that's just what the head of the US Food and Drug Administration's device centre did. Dr Shuren then also went on to argue that – despite there being "some very basic differences between the two systems that confound comparisons" – the US system was more robust than the EU system in ensuring that patients receive safe and effective products.

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