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De Novo Route

Discussion in 'Medical Devices (21 CFR Part 820)' started by Vintage Goose, Feb 2, 2016.

  1. Vintage Goose

    Vintage Goose Active Member

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    Hi, does anyone have any experience with FDA's De Novo route for clearing a low risk device as Class 1 or Class 2, when it doesn't have a predicate?
     

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