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EU-Style Device Approval Poses Patient Safety Risks, U.S. FDA Says
Manufacturers hoping the U.S. Food and Drug Administration (FDA) might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report. “Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the U.S.” lists 12 examples of devices that were authorized in the EU, but found to pose severe risks to patients or not work as intended before they could be approved in the U.S.
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