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Dear Readers, 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, as we report in this issue, 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.
机译:尊敬的读者,杰弗里·舒伦(Jeffrey Shuren)确实不应该暗示欧盟的医疗设备监管体系允许将患者用作豚鼠。但是,正如我们在本期杂志中所报道的那样,这正是美国食品药品监督管理局设备中心的负责人所做的。然后,舒伦博士还继续争论说-尽管“这两个系统之间存在一些非常基本的区别,使比较混淆”,但在确保患者获得安全有效的产品方面,美国系统比欧盟系统更强大。

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