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  • 1.  Changing Product Name symbol from Trademark to Registered

    Posted 05-Apr-2018 13:07
    Dear all,

    I would like to know if you have experience changing a product name symbol from TM to (R), is this a change that needs to be submitted to the notified body as a significant change?

    I appreciate your advice.

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    Natalia Soto
    QA/RA Superintendent
    Alajuela
    Costa Rica
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  • 2.  RE: Changing Product Name symbol from Trademark to Registered

    Posted 05-Apr-2018 17:55
    It does not need to be submitted to the FDA.

    I'm not 100% about other agencies.

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    Michael Nilo
    Network Regulatory Partners
    Portland OR
    United States
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    Original Message


  • 3.  RE: Changing Product Name symbol from Trademark to Registered

    Posted 05-Apr-2018 19:57
    Edited by Lin Wu 05-Apr-2018 19:58
    Had an experience for a 510(k) product, such change was filed internally as No File Decision (NFD) or some company call it Letter to File (LTF), it's a labeling change documented per the flow chart of FDA guidance "modification to an existing 510(k)", it flows to internal documentation.


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    Lin Wu, RAC
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    Original Message


  • 4.  RE: Changing Product Name symbol from Trademark to Registered

    Posted 06-Apr-2018 05:50
    No, this does not require NB notification. This is a marketing change to the label that does not impact the device’s compliance with the ERs.

    Thanks,
    Melinda

    Please excuse any typos or brevity.
    Sent from my iPhone.


    Original Message


  • 5.  RE: Changing Product Name symbol from Trademark to Registered

    Posted 06-Apr-2018 04:57
    As far as I know, this would not require notification to a Notified Body because it does not technically change the known Trade Name or Brand Name of the device.  Now of course the impact of this can be a lot changing all of the labeling, IFUs, and marketing information, but this can be done over a period of time.  In my opinion you would only need to notify if you were changing the actual Trade Name of the device.  Just make sure to document your decision and process internally as others mentioned in a "Note to File".

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 6.  RE: Changing Product Name symbol from Trademark to Registered

    Posted 06-Apr-2018 16:46
    The change in trademark status does not trigger reporting obligations for the reasons others have mentioned, and I typically see it added to the list of changes to be made when some other business process change does trigger new regulatory filings.   

    When things go well with a brand, the name should switch from TM to registered trademark, which shows that you've proven to the USPTO that your use meets the requirements for your mark to be registered.   The regulatory agencies only care about changes that might affect safety, quality, etc.


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    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
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    Original Message


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