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  • 1.  Unique Device Identification

    Posted 24-May-2019 03:07
    Hello,

    Can anyone in this community suggest e-books/materials/articles on Unique Device Identification (UDI on labels and DIrect Part Marking). Thanks in advance.


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    Arun Gokul Barla
    Franklin Lakes NJ
    United States
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  • 2.  RE: Unique Device Identification

    Posted 25-May-2019 12:06
    There are many!

    If you're a beginner, you might start with these FAQs and guidance documents:

    GS1
     - https://www.gs1.org/sites/default/files/docs/healthcare/position-papers/gs1_udi_guide_final_20170324.pdf
     - https://www.gs1.org/industries/healthcare/udi

    HIBCC
     - https://www.hibcc.org/publication/view/hibcc-guideline-fdas-udi-regulation/
     - https://www.hibcc.org/udi-resources/

    United States
     - https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
     - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-direct-marking-devices

    European Union
    ​ - https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

    Saudi Arabia
     - https://www.sfda.gov.sa/ar/medicaldevices/regulations/DocLib/Guide-UDI-MD-ar.pdf

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Unique Device Identification

    Posted 27-May-2019 06:54
    The United States FDA guidance documents and FAQ are very helpful.  Also read the comments and feedback FDA provided during the actual release of the FDA UDI process as there is a lot of information there also about FDA's thinking on how UDI is applied.  Also if you have any specific questions, the UDI Help desk is fair.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Unique Device Identification

    Posted 27-May-2019 21:28
    The US FDA also had a webinar on UDI that you might find helpful. 

    https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-unique-device-identification-direct-marking-devices-final-guidance-november-30-2017

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    Isabella Schmitt
    Regulatory Project Manager
    Houston TX
    United States
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    Original Message


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