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  • 1.  Retail Device UDI

    This message was posted by a user wishing to remain anonymous
    Posted 08-Sep-2022 08:13
    This message was posted by a user wishing to remain anonymous

    Do unclassified devices sold exclusively to retailers need a UDI bar code or is the UPC acceptable under an exception?



  • 2.  RE: Retail Device UDI

    Posted 10-Sep-2022 10:17
    Hello Anon

    I have not seen a general exception for unclassified devices. You might consult with FDA about whether this device could meet the definition of a (normally class 1) "consumer health product".

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices

    Or see the information about requesting an alternative:

    https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-and-alternatives


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    Anne LeBlanc
    United States
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    Original Message


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