Regulatory Open Forum

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  • 1.  UDI Certified Agencies

    Posted 15-Feb-2016 13:46

    What are your experiences using GS1 and HIBCC for assigning UDIs? Any specific pros and cons for one or the other?

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    Jane Keathley
    Principal Consultant
    Keathley and Company, LLC
    Earlysville VA
    United States
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  • 2.  RE: UDI Certified Agencies

    Posted 15-Feb-2016 14:51

    Yes. Cost.

    For us, HIBCC was definitely the way to go.  They have a one-time fee (which was cheaper than GS1 YEARLY fee) and unlimited UDI numbers.  Also, HIBCC was way more responsive initially when I was researching the two agencies.  I have called HIBCC's UDI expert assigned to our company on a number of occasions and had a real conversation about our concerns and received great feedback.

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    Rene' Hardee
    Regulatory Affairs Specialist
    Sun Nuclear Corporation
    Melbourne FL
    United States



  • 3.  RE: UDI Certified Agencies

    Posted 16-Feb-2016 03:21

    Much prefer GS1.  While I agree the cost may be a factor, I thought implementing the GS1 standards (GTIN-14s, etc.) into a company's operations was easier.  This may end up reducing costs in the long run compared to HIBCC.

    One last and very important thing.  Customers much preferred the GS1 standard on the products they buy.

    In the end, you really can't go wrong with either for UDI purposes, but you might want to understand what your customers prefer.

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    Christopher Wilson RAC
    Chicago IL
    United States



  • 4.  RE: UDI Certified Agencies

    Posted 18-Feb-2016 20:46

    GS-1 is the way to go … I concur with Christopher's points regarding the customers.

    Art