ACE PGA Required Data Elements and Values for …

ACE PGA Required data Elements and Values for medical devices Program Will always be DEV Process: Please indicate on of the following selections RED - Radiation Emitting devices NED - Non-Radiation Emitting devices Description Should be the description as per the Commercial Invoice Intended Use: Must be populated with one of the below codes Sub-Code Description For Human medical Use as a medical Device For Human medical Use as a medical Device for Domestic Refurbishing For Human medical Use as medical Device domestically manufactured which is part of a medical device convenience kit For Human medical Use as a medical Device foreign manufactured device that is part of a medical device convenience kit Importation of a device constituent part (finished device) for use in a medical product regulated under a drug (CDER) application type ( , for use in an NDA/ANDA/BLA drug-device combination product). For Personal Use as a Non-Food Product for personal use as a medical device Sub-Code Description For Public Exhibition or Display as a Non-Food Product For Charitable Organization Use as a Non-Food Product Component for further manufacturing into a finished medical device Importation of a device component for use in a medical product regulated under a drug (CDER) application type ( , for use in an NDA/ANDA/BLA drug - device combinatio)

ACE PGA Required Data Elements and Values for Medical Devices Program Will always be “DEV” Process: Please indicate on of the following selections

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