Regulatory Open Forum

 View Only
  • 1.  IVD IMMUNOASSAY Immediate Container (POuch

    This message was posted by a user wishing to remain anonymous
    Posted 05-Apr-2023 07:47
    This message was posted by a user wishing to remain anonymous

    I hope you are doing well. Healgen RA is currently reviewing several IFUs and labels for add-to-file submission. 
    I am seeking your opinion on the FDA's requirements of labeling content for the immediate container or pouch. FDA's guidance on the Immediate container for IMMUNOASSAY products is not very clear. Mostly like FDA considers IMMUNOASSAY under the REAGENT labeling category.  
    The following two FDA links I provided got me more confused. 
    In Vitro Diagnostic Device Labeling Requirements
    U.S. Food and Drug Administration remove preview
    In Vitro Diagnostic Device Labeling Requirements
    Please note: as of October 1, 2002, FDA charges User Fees for review of Premarket Notification 510(k)s and Premarket Approvals In vitro diagnostic products (IVD's) are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
    View this on U.S. Food and Drug Administration >


    Ecfr remove preview
    The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. We recommend you directly contact the agency responsible for the content in question.
    View this on Ecfr >

    My interpretation of IVD labeling regulation is that the Immediate container (pouch) must contain the following-

    - The established and proprietary names of the product
    - manufacturer /distributor information
    - Intended use
    - statement "For In Vitro Diagnostic Use" or IVD symbol
    - Lot 
    - Expiry 
    - Storage condition 

    Private label customers are unwilling to include any information except for Catalog Number, Lot, and Expiry on the POUCH of 510k pregnancy tests or DOA tests. However, the outer package (BOX) will contain all the necessary information required by FDA. 

    Could you please suggest if myinterpretation is correct? 

  • 2.  RE: IVD IMMUNOASSAY Immediate Container (POuch

    Posted 06-Apr-2023 07:56

    Hello Anon,

    There are requirements from 21 CFR 801 and 21 CFR 809 for labelling and specific to labelling IVD medical devices which while the regulation contains requirements, there are some interpretations made.  You are correct in your list, those information should be on "labelling" but the US FDA does not necessarily differentiate levels of packaging including immediate container, pouch, box, carton, etc.  In some cases, the immediate container may not have the available space to list all of the information.  The information on labelling also depends strongly on how the product is packaged and then used by the actual user.  In the example of a pregnancy test, I often see the immediate container (the pouch containing the IVD plastic strip test) containing those three items: catalogue number, lot number, and expiration date (and now often the UDI).  Because often pregnancy "cartons" have 1 to 3 tests, all of the other information available to the user would be on the carton box.  Meaning the user would often not throw out the carton box until they have consumed all of the tests.  It would be recommended to clearly document the rationale and reasons for how information is placed on each level of packaging for the product.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs