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  • 1.  UDI Fee

    This message was posted by a user wishing to remain anonymous
    Posted 21-Mar-2017 10:22
    This message was posted by a user wishing to remain anonymous

    I have a few questions about UDI:

    How soon after FDA 510(k) submission should one begin application of the UDI?
    Is there a set fee for the UDI application?  Is there an annual fee? Or, can anyone give me a ballpark amount I should budget for the UDI?

    Thank as ways for your help and expert advise...





  • 2.  RE: UDI Fee

    Posted 21-Mar-2017 11:45
    There is no direct fee for UDI.  You will need a DI which consists of a company code and unique number for each device.  You purchase a range of numbers and get your company code from your issuing agency (GS1, HIBCC, or ICCBBA).

    Ideally you should have the UDI numbers when you submit your 510(k) labeling.

    The biggest expense will be creating labeling with the bar code and setting up a printing/verification system.

    There is a lot involved including the labeling, writing SOP's, GUDID entry, and direct marking.  Start with reading the UDI rule and the guidances.  There is also material on UDI on CDRH Learn to help you get familiar with the process of UDI application.

    Start now.  If you get 510(k) clearance within 90 days, you will not be ready to go to market with a UDI compliant product.

    ------------------------------
    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
    ------------------------------

    Original Message


  • 3.  RE: UDI Fee

    This message was posted by a user wishing to remain anonymous
    Posted 21-Mar-2017 15:41
    This message was posted by a user wishing to remain anonymous

    Thank you John for the great advice.  I will read the guidance, etc. that you suggested.  I had a different understanding about the process...  As soon as I get a better handle on it, I hope that I can post more questions for you, which I'm certain to have. 

    Original Message


  • 4.  RE: UDI Fee

    Posted 22-Mar-2017 14:51
    You can use GS1 to register your UDI numbers. People seem to overcomplicate UDI compliance in my opinion. It is really quite simple depending on the product. If you are a single use or single procedure device, it is just a matter of registering your UDI which can be done in minutes and then updating your labeling. You can buy an expensive bar code verifier like I did to do your validation in house but I recommend using a bar code verification service. Its fast and it is cheap.  

    You can buy blocks of UDI and the fees are inexpensive. As I recall, I bought a block of 100 for a few hundred dollars. If you have a reusable device or an implant, the device itself will need the UDI. That gets more complicated and will take more time to implement the required design controls. 

    For my class II device single procedure device, I completed the whole process including installing and validating my bar code verifier in two weeks. It was so easy, I went ahead and did the same for my class I devices ahead of schedule. 

    GS1 US has a help desk and they are very friendly and can answer all your questions. They are certified by FDA to issue UDI.
    https://www.gs1us.org/upcs-barcodes-prefixes.

    Good luck!

    ------------------------------
    Scott King
    Vice President, Regulatory Affairs, Quality Assurance & Chief Compliance Officer
    Ceterix Orthopaedics
    Fremont CA
    United States
    ------------------------------

    Original Message


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