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FDA (Simple) Notification for Export

  • 1.  FDA (Simple) Notification for Export

    Posted 20-Aug-2013 13:59
    I am conducting a study outside of the US and sending devices (class III implantable) to Tier 1 countries.  I am required to send a simple notification to the FDA of this impending export via Section 802.  Does anyone have a template that they have used for this purpose or any guidance on doing this?

    Thank you,

    Karen Jaffe

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    Karen Jaffe RAC
    Irvine CA
    United States
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