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.

One major difference between the two approaches is that Europe’s notified bodies system requires only that a device appear to be safe and work on a technical level, while the FDA requires safety as well as effectiveness and benefit to patients. Notified bodies also tend to be willing to approve devices based on such limited data as lab testing, literature reviews or small trials, while the FDA generally requires randomized clinical trials of high-risk new devices. That means higher-risk devices tend to make it to market in Europe several months or even years later, the report notes.

But that’s not a bad thing, the FDA said. “The limited testing required in the EU can fail to predict dangerous risks and lack of effectiveness in actual use.” In addition, the lack of centralized adverse events and recall reports in Europe make it hard to tell when a device might pose unacceptable risks, the agency said.

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