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Newsletter - December 21, 2017
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Least Burdensome Approach: FDA Says Do Less to Succeed More

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FDA would like developers of new medical devices do fewer clinical trials, use clinical trial data from outside the US, rely on data from uncontrolled open-label studies, and use unconventional data to support PMA and 510k applications. Manufacturers should try to “use the minimum amount of information necessary... Read More

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