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  • 1.  Unique Device Identifiers

    Posted 07-Oct-2019 05:30

    Hi All.

    I am hoping to submit our Technical File to the FDA at the end of the year and was wondering people could guide around how the UDI works! I believe there are three agencies accredited to do this. I may have mis-read somewhere but I believe the UDI cannot be attained until we have received clearance, am I correct with my thinking?

    Does anyone have any tips for this process, easy things that could be forgotten when applying for the first time?

    Thanks

    James



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    James
    Head of QARA
    UK
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  • 2.  RE: Unique Device Identifiers

    Posted 07-Oct-2019 18:02
      |   view attached
    The US has 3 issuing agencies (GS1, HIBC, ICCBBA). You can assign a Device Identifier (DI) after registering with an issuing agency, and the Production Identifer (PI) can be determined later, but before you start printing labels. You are not able to submit to the GUDID until you have a 510k, submission number, product code, etc. from the FDA. Attached is a list checklist of sorts of actions that need to be done when implementing UDI in the US. This is under revision for the EU process.

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    Lena Cordie-Bancroft
    Victoria MN
    United States
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    Original Message


  • 3.  RE: Unique Device Identifiers

    Posted 08-Oct-2019 02:47

    Thanks Lena, this helps. Just to clarify though :-)

    We had a pre-sub where a Q number was given, will this be a different when we do the actual submission? If not, I could use this to get the UDI now? If the number is different, which I expect, I can register with HIBC for example but will not be able to get the unique number (PI)

    Thanks



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    James
    Head of QARA
    UK
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    Original Message


  • 4.  RE: Unique Device Identifiers

    Posted 08-Oct-2019 08:08
    James,

    There is lots of helpful information FDA has published on UDI including a nice guidance/FAQ document here https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.  The process of obtaining numbers for UDI is not necessarily handled by the FDA - they only have the GUDID database.  You would obtain a Device Identifier number through one of the Issuing Agencies.  Then you would gather all of the product information needed for database entry.  Then you would create an account on the GUDID system under your company.  Once that is done, you would enter all of the relevant information in the GUDID system.  There is really no "submission" you just log in the system and keep information in the GUDID up to date.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Unique Device Identifiers

    Posted 08-Oct-2019 12:30
    Hi James,
    I would strongly recommend GS1 as your vendor of choice for UDI. Their web-portal is intuitive, utility for barcode and UDI generation is self-serve and there is no formal contracting - you pay up front for what you plan to use. Please check out their relevant documentation surrounding UDI here:
    - https://www.gs1.org/sites/default/files/docs/healthcare/a3-ready_for_udi-bd.pdf
    - https://www.gs1us.org/DesktopModules/Bring2mind/DMX/Download.aspx?Command=Core_Download&EntryId=390&language=en-US&PortalId=0&TabId=134
    - https://www.gs1us.org/DesktopModules/Bring2mind/DMX/Download.aspx?Command=Core_Download&EntryId=632&language=en-US&PortalId=0&TabId=134

    You may also be interested in some FDA trainings here:
    - http://fda.yorkcast.com/webcast/Play/3e1557a3ba4a4de1aac3d07bf8cdf0ee1d
    - http://fda.yorkcast.com/webcast/Play/c3f1d47f147e4865937b6a0f8f1dcdc21d
    - http://fda.yorkcast.com/webcast/Play/455307461f76415ead204eeb03dedad61d

    This guidance is also helpful:
    - https://www.fda.gov/media/89222/download

    Its great you are starting this now. The earlier the better as it does take some time to wrap your head around how the process works, identifying the right personnel within your organization to help see this through, and all items that will need their own UDI. I would suggest querying the GUDID database for products that share the same product code as your device, including your predicate device (assuming you are traveling down the 510k pathway) to get a sense of what to expect. 

    Lastly, you can generate your UDI(s) now so long as you have assurance of the final packaging will not change upon market clearance within the US (even if it does change, the amendment could be fairly straightforward just be sure you have a process in place for managing this once the product is launched). It is the registration of your UDI(s) with the US' GUDID that will need wait until a) your facility is a registered establishment (https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee) and b) you have approval of the product and the product is listed under you registration.

    Best of luck,
    Danni

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    Danielle Briggeman MS
    Clinical & Regulatory Affairs Manager
    Portland ME
    United States
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    Original Message


  • 6.  RE: Unique Device Identifiers

    Posted 09-Oct-2019 03:35
    Thanks all, this information is very very welcome.

    @Danni - I had looked at the three and was already thinking that GS1 was looking the best option and like you have said, much more of an intuitive ​website. This is our first FDA submission and yes we are going down the 510(k) route so a big learning curve, especially as my background is QA and not RA! The UDI should be quite straight forward as we are a software company developing one product, hopefully nice and easy but this is probably wishful thinking from me! 

    If you have any pearls of wisdom that you have learnt over the years, please feel free to let me know :-).

    Thanks
    James

    ------------------------------
    James
    Head of QARA
    UK
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    Original Message


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