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Ann: Update on US FDA De Novo Classification Request, page-7

  1. Cosmoterios
    18,738 Posts.
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    11/03/20
    10:02
    Post #: 43420399
    If they are knocking back a De Novo application (probably the easiest path to get through), you really have to ask what are the issues here.

    Is the product Not similar to an existing product already approved?

    RAP Price at posting: 17.0¢ Sentiment: None Disclosure: Not Held
    Likes Created with Sketch. 3  Upvote
    lightbulb Created with Sketch.  Great analysis
    Stroke 3 Created with Sketch. Comments Created with Sketch. Reply

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