Regulatory Open Forum

 View Only

  • 1.  UDI Barcodes for Kits

    Posted 05-Nov-2014 12:41
    Good Afternoon Everyone,

    Question for those out there that are in the process of amending labeling for the new UDI requirements.  We are a class II IVD reagent manufacturer.  Our new product is supplied as a kit of 3 vials of controls.  The kit has a master lot number and the three vials contained in the kit have the master lot plus one extra digit (to distinguish them).  Currently, the barcode is setup with the lot number so that the end user can scan into their instrument system to know which vial they are using.  My question is, do each of the 3 vials need a UDI or will a UDI for the kit as a whole suffice?  (The kit is a small box with the 3 vials enclosed). 

    Any help is greatly appreciated.  Thanks!

    -------------------------------------------
    Ryan Gilmore
    Director, Regulatory Affairs and Quality
    Chapel Hill NC
    United States
    -------------------------------------------


  • 2.  RE: UDI Barcodes for Kits

    Posted 05-Nov-2014 21:21

    You can have one UDI for the kit. The primary element on the kit is the Device Identifier. You would also use optional production identifiers, such as the lot number and expiration date for the kit. The vials in the kit don't need a UDI.

     

    You don't assign the numbers; you contract with accredited agency who will tell you how to form the numbers and the allowable format for the data carrier, i.e., the bar code. Currently, there are three accredited agencies. There is the quite real possibility that the data carrier you currently use for your bar lot number is not in the format required by the accredited agency.

     

    Don't forget to change the human readable date format on the label.

     

    There are two other major elements. You will have to populate the CDRH GUDID and you have to update many of your procedures. The procedure updates were due Dec. 23, 2013. The label changes and GUDID for a "straight forward" Class 2 device should be complete by September 24, 2016.

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


    Original Message


  • 3.  RE: UDI Barcodes for Kits

    Posted 06-Nov-2014 03:41
    Hello Ryan,

    I have the same experience as Dan.
    A consultant of us contacted FDA with a similar question. The answer of FDA was as follows:

    "Q: Can a package containing more than one identical products only have one UDI, without having the individual products identified? Or, should all individual products in the package have a UDI? (background information: the products cannot be used without the information contained in the box, IVD products)
    A: In general, the FDA rule requires that each device package of every convenience kit carries a UDI.  As long as the label of the kit shows a UDI, devices contained within a convenience kit are exempt from UDI.

    IVD's must have a UDI. In terms of what is inside, are the "products" truly "identical"?  If so are each individually considered a "medical device"?  If so, could they each be marketed and sold in the US individually?  If the answer is yes to ALL of them, they need individual UDIs when sold individually but not when sold as a "kit" (IVD)."

    I hope this helps Ryan.


    -------------------------------------------
    Paul Kooijmans
    Regulatory Affairs manager
    Eurotrol B.V.
    Ede
    Netherlands
    -------------------------------------------






  • 4.  RE: UDI Barcodes for Kits

    Posted 06-Nov-2014 15:36
    Hi Ryan,
    This is from GUDID guidance document: Section 10.4

    10.4 IVD Kits

     

    IVD kits should follow the rules listed below:

     

    1. The manufacturer of the IVD Kit is responsible for identifying it with a UDI including both UDI-DI and UDI-PI,

       

    2. Medical device contents of IVD Kits should have a UDI Carrier on their packaging or on the device itself,
      1. The IVD Kit is a device and all aspects of this guidance that is relevant apply to it. If an IVD Kit does not include any components which on their own are considered medical devices the only UDI is the UDI of the kit itself;
      2. Reagents used in automated systems bear barcodes necessary for their handling and identification by the automated systems. This does not constitute a UDI;
      3. Individual single-use medical devices packaged within an IVD Kit, whose uses are generally known to the persons by whom they are intended to be used, and which are not intended for individual use outside the context of the IVD Kit do not require their own UDI Carrier;
      4. Medical devices that are normally exempted from having a UDI Carrier on the relevant level of packaging do not need to have a UDI Carrier when placed within an IVD Kit.

         

    3. Placement of UDI on IVD Kits:

       

      1. The IVD Kit UDI is generally affixed to the outside of the packaging;
      2. The UDI must be readable or in the case of AIDC scan able, whether placed on the outside of the IVD Kit package or inside a transparent package.
    Hope it is helpful.

    -------------------------------------------
    Chandar Thakur PHD, RAC
    Sr Regulatory Affairs Scientist
    USAMMDA
    United States
    -------------------------------------------


    Original Message