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The CE Mark in the European Union and the FDA-approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new devices. FDA approval, however, is significantly more expensive to obtain for a number of reasons:1.

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FDA approved vs. FDA cleared:Why you need to know the

Jun 13, 2019 · FDA approved vs. FDA cleared:Why you need to know the difference. We're going to see a lot more consumer tech devices get the FDA's blessing. Here's what you need to know.

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