Regulatory Open Forum

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  • 1.  UDI Question

    Posted 22-Jan-2018 16:50
    Are there any new or existing requirements that can be referenced for who must be the UDI labeler in situations where one company owns the device design and regulatory path, but allows a customer to use their own branding on the device. The customer then acts as the distributor of their branded product. In this scenario is there a requirement that the brand owner (customer/distributor) is responsible for UDI?

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    Andrea Curria
    Regulatory Affairs Specialist
    Teleflex Medical
    United States
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  • 2.  RE: UDI Question

    Posted 23-Jan-2018 08:14
    Andrea,

    If you are referring to the US FDA UDI, the responsibility lies with the "labeler" or that entity that is placing the actual label on the device and/or packaging.  Now this does not mean that some other entity can take responsibility such as maintaining the GUDID database or getting the actual DI number.  There may of course be many situations or relationships of companies that should be (must be) described in a contract or agreement about who does what for UDI requirements.

    In your situation, Company A who does design and regulatory pathway and Company B is the customer/distributor, Company B as placing the label on the device would be responsible for UDI.  If indeed they do all packaging and labeling of the finished device.  Now if Company A does the packaging and labeling for Company B, then Company A would be considered the labeler, thus responsible for UDI.  There may be some slight variations or exceptions, but based on your information this sounds like an appropriate method.

    Hope that helps !

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: UDI Question

    Posted 23-Jan-2018 08:46
    I read your question as this is a "private labeled" product, where you spec and manufacture but allow another company to appear to have manufactured it by branding under their name.  If this is the case, the UDI is theirs.  If you are using GTINs, it is simple to understand that whomever owns the GTIN is UDI responsible. 

    From FDA website:  

    What is a Labeler? The labeler is responsible for compliance with the UDI requirements. The UDI rule created the term "Labeler", and in 21 CFR 801.3 the labeler is defined as the one who causes a label to be applied to a device, or who causes the label to be replaced or modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label.

    A device manufacturer is usually the labeler, but not always. The term labeler can include contract manufacturers, private label distributors and  convenience kit assemblers, as well as device repackagers or device relabelers. However, distributors who only have their name and contact information added to an existing label may not be considered labelers.

    Hope this helps.



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    D Michelle Williams
    United States
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    Original Message


  • 4.  RE: UDI Question

    Posted 23-Jan-2018 12:07
    From FDA's website:

    A "labeler" is any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. 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. 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.

    Automatic identification and data capture (AIDC) means any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.

    Based on this if your customer only adds their name to the label, the company owning the device design and regulatory approval would be the labeler.



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    Karin Sailor
    Consultant
    SRO, Inc.
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    Original Message


  • 5.  RE: UDI Question

    Posted 24-Jan-2018 09:51
    ​In my experience asking the FDA this same question at various conferences, they have indicated that the roles should be negotiated between the trading partners and agreed upon in the form of a quality agreement. I have also heard responses indicating that the labeler should be the organization which the end user would reach out to in the case of an issue, which leans towards a preference of the Brand owner taking on the  role of the "Labeler" for UDI purposes.

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    Maria V. Vrabie
    Director of Regulatory Affairs
    Hu-Friedy Mfg. Co., LLC
    Chicago, IL
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    Original Message


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