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  • 1.  Can our supplier use our DEV/DFE on their shipment invoices?

    This message was posted by a user wishing to remain anonymous
    Posted 07-Apr-2022 15:10
    This message was posted by a user wishing to remain anonymous

    Our non-US supplier ships spare parts to US using our DFE/DEV number. Is that okay if the spare parts are coming directly from their facility and not from our facility?


  • 2.  RE: Can our supplier use our DEV/DFE on their shipment invoices?

    Posted 12-Apr-2022 12:37
    Hi Anon

    If it's a finished device, they should have their own DEV qualifier. See
    https://www.fda.gov/media/96145/download

    If it's truly a spare part, and not a medical device, then I don't know why the FDA ACE Affirmations of Compliance would even be relevant.

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    Anne LeBlanc
    United States
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    Original Message


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