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crudeoil24

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Re: mick post# 828

Wednesday, 01/12/2022 2:45:34 PM

Wednesday, January 12, 2022 2:45:34 PM

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The ideal review time stipulated by the de novo regulation is less than 60 days. However, in 2010 the average turnaround time for a de novo device was 241 days. And when you look at start to finish — from the initial 510(k) submission to de novo market approval — the average overall time was about 480 days.

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