EU-Style Device Approval Poses Patient Safety Risks, FDA Says

Manufacturers hoping the 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 used in patients 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.
Devices & Diagnostics Letter