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  • 1.  Citation to Permit Electronic DFUs - Medical Device US market

    Posted 12-Jan-2024 17:01

    I'm searching for a citation (to some FDA document) that enables medical device DFU's to be distributed electronically, by QR code, by website etc. 
    I've searched the Guidance but cant find. What am i missing?  Any help appreciated. 

    Thanks!



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    Kevin McLellan
    Owner
    Memphis TN
    United States
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  • 2.  RE: Citation to Permit Electronic DFUs - Medical Device US market

    Posted 13-Jan-2024 07:08
      |   view attached

    Hello Kevin

    See attached.

    Kind regards

    Hans

    __________________

    Hans Strobel
    www.dokspot.com



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    Hans Strobel
    www.dokspot.io
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  • 3.  RE: Citation to Permit Electronic DFUs - Medical Device US market

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jan-2024 11:10
    This message was posted by a user wishing to remain anonymous

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-acceptable-media-electronic-product-user-manuals

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling