Regulatory Open Forum

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

    Posted 07-Apr-2022 09:31
    Our non-US supplier ships spare parts to US using our DFE/DEV number on their invoices. Can they do this if the spare parts are coming directly from their facility and not from ours?


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

    Posted 27-Apr-2022 23:40
    I'm sorry you don't have an answer yet. I had to look up what those numbers are. You can get a quick answer at the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health,

    You can also try this page:  https://www.fda.gov/industry/common-entry-submission-errors/medical-device-common-entry-errors

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    Andrea Chamblee Esq., RAC, FRAPS
    Senior Counsel, Wilson Sonsini

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
    This is not intended as legal advice. Consult a lawyer for your specific matter.

    Maryland
    United States
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