1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

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

    Oct 6, 2015
    Likes Received:
    Trophy Points:
    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?