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  • 1.  Submit AI to CDRH in person

    Posted 25-Aug-2019 14:36
    Hello! I am wondering if anybody has experience in submitting additional information to CDRH in person instead of using courier? How can I drop off the document to DCC in person?

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    Xiaoming Hong
    Tianjin
    China
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  • 2.  RE: Submit AI to CDRH in person

    Posted 26-Aug-2019 08:27
    You can deliver the package/submission direct to the FDA receiving doc in Silver Spring, MD and have DCC receive your package and get a stamped confirmation. This will not be the acknowledgement email that is system generated but it will be issued the same day if you drop it off early in the morning.  You will have to clear security with the vehicle, tell them your intention to deliver a package to the receiving dock.  The process takes about 30 minutes.

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    Mac McKeen, RAC RAC, MBA
    Fellow, Regulatory Science
    Maple Grove MN
    United States
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    Original Message


  • 3.  RE: Submit AI to CDRH in person

    Posted 26-Aug-2019 11:30
    Yes, you can hand deliver an AI response or submission to CDRH.  You tell the person at the gate of the grounds what you want to do and they will direct you to the CDRH building and you can hand deliver it to the document mail center.

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    Natalie Kennel RAC
    QA/RA Consultant
    San Diego CA
    United States
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    Original Message


  • 4.  RE: Submit AI to CDRH in person

    Posted 26-Aug-2019 13:11
    You can ask a legal firm - Hogan Lovells or King and Spaulding come to mind - who have offices in DC to delivery it for you.

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    Peggy McLaughlin
    United States
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    Original Message


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