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  • 1.  UDI-Medical Device Class II

    Posted 04-May-2016 15:31

    Hello Everyone,

    We are in the process of updating our systems to become complaint with the UDI Rule. We are a small company, but carry over 4,000 different parts we relabel/repackage. Currently, we use a very generic Avery label for our product, but with the new rule I was wondering how other companies are handling the new requirement. It seems there are a lot of outside companies needed to make this rule work. We have hired Emergo as our consultant, have purchased new labeling software (that will allow us to have the barcode as well as the human readable symbols), have become a member with the GMDN, are looking into purchasing a third party software for the GUDID submission, and have signed up with GS1 as our accredited agency. My questions are:

    1. Is there a company that can do this all? Print proper labels, be an accredited agency, submit information to the GUDID?

    2. Are there other companies who are experiencing having to hire/bring in a lot of outside companies to make the UDI complaint?

    3. What is the average cost companies are seeing with the new regulation?

    Thank you very much!

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    Lauren Combs
    Quality Assurance Manager
    Grover Beach CA
    United States
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  • 2.  RE: UDI-Medical Device Class II

    Posted 04-May-2016 19:40

    I deal with many small companies in a variety of aspects including a lot of work with UDI.

    There are three legs to UDI implementation, but many companies only consider one or two.

    You must implement UDI on the device labels for all of the appropriate levels.

    You must load, and maintain, GUDID for each base package and primary DI.

    You must update your QMS.

    The last item is significant. The rules for QSR, MDRs, and Corrections and Removals went into effect on Dec. 23, 2013. If you have not yet updated your procedures, you are out of compliance and risk a 483 and a warning letter.

    I’m interested in you comment “we use a very generic Avery label for our product”. This comment, coupled with your statement that you “carry over 4,000 different parts we relabel/repackage” makes we wonder how much of the UDI applies. If you are registered as a relabeler or repackager and list all 4,000 products, then UDI applies to all of them. However, if you are adding your own information to the manufacturer’s label, then UDI may not apply.

    If you are a relabeler or repackager, then QSR applies. This implies you have a DMR and create a DHR. The DHR includes the primary label which is usually the label for the base package and carries the UDI.

    You are right that there are many outside companies potentially involved in UDI. Don’t forget that each one is a supplier, so you must qualify and manage them under 820.50.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 3.  RE: UDI-Medical Device Class II

    Posted 05-May-2016 07:51

    I thought about this question and realized that I should have included the definition of a labeler. Here is one part of the definition, which has an exception for a company that adds information. Your description made me think the exception may apply to your company.

    Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 4.  RE: UDI-Medical Device Class II

    Posted 05-May-2016 09:27
    Lauren,

    In view of your questions, it reminds me of my client in NC.

    I would recommend you please identify and map the UDI requirements applicable for your products with Dan O'Leary and your Emergo consultant.

    Per UDI Final Rule, it states "in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler."

    In other words, what is best to move forward?

    Your firm would also want to communicate with the original manufacturers concerning your UDI/labeling practice. 

    Unless parties (between relabeler/repackers and original (brand name) manufacturers) reach an agreement, private labeling practices may no longer be sustainable under UDI environments.  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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    Original Message


  • 5.  RE: UDI-Medical Device Class II

    Posted 06-May-2016 09:20

    There are companies that can help you with both labeling and GUDID submission, but the Issuing Agency is a separate responsibility and currently limited to GS1, HIBC and ICCBBA. With 4000+ SKUs, you will want to work with a 3rd Party Submitter unless you have an HL7 SPL & XML expert already in-house. If you decide to go with two different companies for labeling and GUDID submission, you will want to ask if the two systems can be integrated so you only have to work with one database. This is one benefit of using a full-service provider. Additionally, some of these companies also provide consultant services or have preferred consultants that they recommend. And as Dan mentioned, do not overlook the impact of UDI compliance on your quality system. UDI is a process and not simply a project, so incorporate it into your quality system as you would any other process your company has.

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    Lena Cordie
    Qualitas Professional Services
    Watertown MN
    United States

    Original Message


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