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Successful De Novo Petitions Double With Advent Of Direct Route

This article was originally published in The Gray Sheet

Executive Summary

FDA granted more than double the number of de novo petitions in FY 2013 compared to past years, reflecting the availability of the direct de novo pathway recently established by Congress. De novo petitions allow a device that FDA deems to be low-to-moderate risk but without a clear predicate to enter the market without requiring a PMA.

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