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  • 1.  Device Listing Management

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jun-2023 15:02
    This message was posted by a user wishing to remain anonymous

    As a manufacturer of finished devices for OEMs, we struggle with managing Device Listings. Two key examples:

    We may receive an email from our customer to identify the device listing for a specific part number which my organization has never tracked. In response, we ask for the 510K number which correlates to the Device Listing, thus allowing us to provide the Device Listing number.

    Upon release or after shipment of a new release there is a mad rush to establish a device listing. Development lacks appreciate for proactive inclusion to the process to avoid shipment delays.

     QUESTIONS:

    What mechanism do you use to:

    1)      Ensure Device Listings are established prior to shipping newly release products?

    2)      Track device listing to product? (ERP vs Excel for example)

    3)      Share the Device Listing number with the customer? (Ours request a dated pdf from FURLs)

    Thank you for sharing your insights,

    Anonymous Friend



  • 2.  RE: Device Listing Management

    Posted 12-Jun-2023 15:04

    Automation could be an option, implement a centralized database or a Product Lifecycle Management (PLM) system that can store and manage information about your products and their associated device listings.



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Device Listing Management

    Posted 13-Jun-2023 01:50

    Hello Anon,

    Best practices I have seen and put in place is having a procedure/work instruction for managing the FDA establishment and medical device listings.  This procedure is then linked to either/both the design control process and change management process.  Therefore, when there is a change to a product perspective (like Trade Name), new model introduced, or new device introduced, this would be a process followed by quality/regulatory.  Most of the time it is a manual process/manual reminder because the quality system forms would have this information contained, but then someone would actually need to log into the system to update/add.

    A type of medical device listing is then kept such as an Excel spreadsheet (basic) or using a management software (advanced) to keep track of the device listings and current status.  The good thing about medical device listing with US FDA is it does not take that long to enter the information and there is no "approval" process so generally it shows up on the website in a few hours to days.  You could either take a screen shot of the device listing for your customer, provide the link, or have a more formal document which lists the products and the device listing numbers.  In this process of medical device listing management, there are a few ways this could be managed, controlled, and updated.



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


  • 4.  RE: Device Listing Management

    Posted 13-Jun-2023 10:38

    I'll assume this is a 510(k) device.

    There are two process to consider. One is UDI and the other is a 510(k) submission.

    When you make a design change to a device you need to consider whether the change creates a new version or model which means all devices that have specifications, performance, size, and composition, within limits set by the labeler. If so, this will trigger a new UDI-DI. Also, there are 12 attributes in GUDID which, if changed, require a new UDI-DI.

    Also for every change determine if it is significant using the flowcharts and texts in the FDA guidance documents.

    The problem is that a new UDI-DI trigger may not be a new 510(k) trigger. For example, a new size triggers a new UDI-DI but not a new 510(k).



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 5.  RE: Device Listing Management

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jun-2023 09:48
    This message was posted by a user wishing to remain anonymous

    1) I don't sign the shipping authorization until the regulatory steps are complete. More than that, I remind the project manager and the sales team multiple times that there's a step they'll have to plan for or wait for.  And I give them control of the timing -- letting them choose if we should get the listing done a little early or wait until they're just about ready to start shipping and promoting, to help preserve their element of surprise when it appears.

    2) Our ERP isn't that capable. We find it simpler to use Excel.

    3) I write them a letter to communicate our listing number formally (and keep a copy to re-send if their files get scrambled).


    Original Message


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