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  • 1.  UDI for accessories

    Posted 22-Mar-2018 19:23

    Hi,

     

    What happens if the manufacturer of the accessories for our devices does not agree to put on their UDI for the accessories ? Do we ( device manufacturer) then put on our UDI , but then that means we become the legal manufacturer /labeller of the accessories?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

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  • 2.  RE: UDI for accessories

    Posted 23-Mar-2018 03:13
    Rashmi,

    Ahh the complicated world of regulatory and UDI !  My first question is do you really need a UDI on the accessory?  While in the strictest sense it probably needs UDI and you have probably determined it needs a UDI.  You could look at it for a justification for not doing UDI.  Though in my experience accessories usually need UDI since they are used with the device or needed with the device - so good tracking ability is also needed.

    So to answer your question, I do not believe it would make you the legal manufacturer of the accessory if you were to add only a UDI label to final package.  Would you be the UDI Labeler by FDA definition? Yes.  Would you be considered a re-labeler by FDA definition? Maybe.  If the manufacturer of the accessory is not going to put a UDI on the product, then I would say you can, just making sure you are following all the UDI requirements for getting DI, entering into the GUDID, and being aware of any changes to the accessory.  And of course document all this, reason for you putting the UDI on, when the UDI is put on, how the UDI is put on, and how packaging, labelling, and quality are controlled.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: UDI for accessories

    Posted 23-Mar-2018 22:26
    ​Hi Richard ,

    The accessory can be supplied separately from the device and is a reusable device (class II)  so it becomes necessary to have the UDI on, especially if there's an adverse event , it could become an issue, not to have one . The GUDID details would be pertaining to us and not the accessory manufacturer .So then the labelling also needs to change accordingly  as Manufactured for ... and not manufacturer name ...? But then we become liable in case of an adverse event , isn't it?

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    RashmiAdelaideAustralia
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    Original Message


  • 4.  RE: UDI for accessories

    Posted 25-Mar-2018 05:18
    Rashmi,

    In my experience, there are quite a few accessories that need UDI, as you explain it is necessary from a regulatory, traceability, and other standpoint.  To answer your question, my own personal thoughts, because you are not necessarily changing anything beyond adding a UDI label, I would not worry too much about the Manufactured By and Manufactured For.  However, because you are adding a label that falls directly under a regulation, i.e. 21 CFR 801 and 830, you should make sure your listing is covered as a re-labeller, just to be on the safe side.  The Manufactured By and Manufactured For really depends on the actual device itself.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 5.  RE: UDI for accessories

    Posted 26-Mar-2018 09:24
    Dear Rashmi,

    Agreed, a Class II accessory needs UDI. Another consideration is if the accessory was submitted as part of the 510(k), and if it was specifically included in the instructions for use for your device, it is additional support that UDI is required.

    Pertaining to legal manufacturer and who would apply the UDI label and manage GUDID, it depends on the relationship between the two companies, who owns the design, how complaints and medical device reporting is handled, and how the accessory is labeled today. Without knowing all the specific details, it's hard to give an exact answer. The relationship of the companies is clarified on the label. From 21 CFR 801.1 (c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as "Manufacture for device; such as, "Manufactured for __", "Distributed by__", or any other wording that expresses the facts. (e) If a person manufactures, packs or distributes a device at a place other than his principal place of business, that label may state the principal place of business in lieu of the actual place where such device was manufactured or packed or is to be is distributed, unless such statement would be misleading.

    There is also an FDA helpdesk for additional support, you can ask them about your specific scenario. https://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/ucm368904.htm.



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    Julie Warren
    Regulatory Technical Specialist
    Newark DE
    United States
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    Original Message


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