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  • 1.  Differences in UDI Date formats and Use By information

    Posted 24-Jan-2020 04:20
    Hi All,
     I have some question regards how the expired/lot based products may be traced based on the Use-By Indication.
    https://www.fda.gov/files/udi-label-example_1.jpg
    If, say a product has expired, or is beyond a Use-By date. how would this product be traced to the shipped Lot?. is there a specific check to be made to trace the lot with the UDI?. I see a CAT and LOT label which are not listed as mandatory. Are these traceable to GS1/EUDAMED or Manufacturer supply chain software?.

    Which Standard is applicable for numbering?.
              ISO/IEC 646:1991, Information technology - ISO 7-bit coded character set for information interchange  IMDRF guidance Doc
    Section 6.4 Auto Identification Data Capture (AIDC) representation of UDI
    or
               ISO 8601 DATE AND TIME FORMAT( is this US FDA specific?)

    In another example we have Package and Labels for a Software CD. How would the User know a specific version of software from the UDI. The Listed UDI-DI needs to be on the outer carton/package rather than on the CD Label to know the version being shipped. Shipped Software needs to be identifiable by country/language option.
    Would a Graphic listing this option suffice?.
    Are there any details the Manufacturer has to list?.

    IMDRF Guidance: http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-udi-system-n48-180712.pdf
    Ref:
    1. ICCBA does not list Expiry format
    2. GS1 UDI samples
    3. HIBCC Expiry format  does not list Dates in UDI


    ------------------------------
    Vikram Upadhya
    Tech Lead
    MDD-MDR Transition
    HCL Tech
    India
    ------------------------------


  • 2.  RE: Differences in UDI Date formats and Use By information

    Posted 27-Jan-2020 20:16
    Hi Vikram,

    The UDI is generally comprised of two portions, a fixed 'device identifier' portion and a variable 'production identifier' portion.  The 'production identifier' portion typically includes production information the firm has determined to use for traceability purposes (e.g. lot number, serial number, expiry date, manufacturing date).  The UDI format and requirements are specified by each issuing agency (e.g. GS1). 

    How the UDI is stored will depend on the firm.  It is possible to store UDI is specialized software.  The firm would need to determine how best to implement systems to facilitate product traceability.

    UDI labeling requirements specific to the FDA can be found in the FDA's UDI Final Rule as well as various FDA guidances on UDI (can be found by searching the FDA website).  I believe requirements for software are discussed in these resources.

    I hope this was helpful.


    ------------------------------
    Camille Thorpe, RAC (Canada)
    Toronto, ON
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Differences in UDI Date formats and Use By information

    Posted 28-Jan-2020 06:02
    Hi Camille,
      Good Day and Greetings, 

    Thank you for the details provided. I was looking at the way the 3 Listed references replace existing Labelling and Packaging Standards - in light of EU MDR.
    From what i understand there are 3 primary requirements as Dan pointed out "There are three concepts often convolved: identification, tracking, and tracing."in the Basic UDI-DI thread. 

    The question i had was with tracking and tracing with respect to 
    1) Use By Date - which is documented in the GS1 Label , i note that HIBCC Labels do not have Expiration date easily identifiable.
    2) Tracing the version of software in a Carton - software without opening the package - to list version details - if this is possible with the basic UDI.


    So GS1 Labels are thorough for the Use By/Expiration labels - is the Expiration date needed for devices which have a Use By date - if so would other Labelling agencies change their format?.


    ------------------------------
    Vikram Upadhya
    Tech Lead
    MDD-MDR Transition
    HCL Tech
    India
    ------------------------------

    Original Message


  • 4.  RE: Differences in UDI Date formats and Use By information

    Posted 28-Jan-2020 08:40
    Hello Vikram

    The normal expiration date tag for HIBCC is $$5, although that's not the only option. Here's the standard: https://www.hibcc.org/wp-content/uploads/SLS-2.6-Final.pdf​

    And yes, if your label shows a use-by date, it has to be included in the UDI-PI.

    For a software device, if it's a different version, it gets a different UDI-DI.

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 5.  RE: Differences in UDI Date formats and Use By information

    Posted 29-Jan-2020 02:57
    Good Day Anne,
        I feel we still have some gaps with our current UDI mapping since the release information needs to be Electronic eIFU format. I will refer to the HIBCC resources for more clarification. 

    I would like a comparision between the 3 UDI agencies to know how best to map existing MDD to MDR transition since multiple standards may be applicable- once EUDAMED is live.Please share any relevent and current resources for this decision.

    thank you for the Inputs,




    ------------------------------
    Vikram Upadhya
    Tech Lead
    MDD-MDR Transition
    HCL Tech
    India
    ------------------------------

    Original Message


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