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The FDA is making the process of obtaining 510ks a lot more difficult. The predicate-device process is coming under scrutiny for a lot of new devices, which were approved under the 510k system, even though they may share only a trivial similarity with a devices on the market. This new 510K approvalprocess will also have an impact on the CE certification process, which relies on notified bodies. They have to get aligned with the more stringent criteria for predicate medical devices.