Regulatory Open Forum

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  • 1.  disclaimer in an advert

    Posted 30-Aug-2017 02:33
    Hi,
    we have planned an advert in the US. Do we need the following disclaimer (currently used in our brochures)?
    Federal Law (USA) restricts this device to sale by or on the order of a physician. Read and understand operation manual before use.

    Is their any clear guidance on that?

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    Frank Wilmerstaedt
    Hamburg
    Germany
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  • 2.  RE: disclaimer in an advert

    Posted 31-Aug-2017 08:29
    ​Hi Frank.

    My understanding (and I am by no means an expert on this topic) is that any time a product is meant to be available to the final "consumer" by prescription only (for sale by or on the order of a physician) I believe that all advertisements in the US will require this disclaimer generally.  I will however be very interested to learn if my understanding is correct or if it is over-simplified.

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    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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    Original Message


  • 3.  RE: disclaimer in an advert

    Posted 01-Sep-2017 04:46
    The disclaimer is fine, but there are many other requirements within the regulations and guidance to which you must adhere to ensure the advertisement is truthful, not misleading and fairly balanced.   If it is targeted as a direct-to-consumer there are additional expectations FDA has of you.  

    Mark DuVal, J.D., FRAPS
    DuVal & Associates, P.A.

    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 4.  RE: disclaimer in an advert

    Posted 03-Sep-2017 21:30
    Hi Frank,

    Your disclaimer could be slightly different depending on the device and the levels of risk (Class II or III). A PMA device would require a brief statement of use/indications and warnings, etc.

    A reminder ad would not contain a disclaimer.

    And Yes, it's confusing!


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    Carol Cooper, MS RAC
    Principal
    CM Cooper & Associates
    Libertyville IL
    United States
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    Original Message


  • 5.  RE: disclaimer in an advert

    Posted 05-Sep-2017 03:03
    ​Hello Frank,
    tis is e material I'm studying to understand Labeling requirements in the US. couldn't find a clear overview. the current goal has been to map minimum content against the specific asset (e.g. marking, IFU, packaging, adverts, ...)
    Happy to share results when done.
    Cheers,
    Cate

    https://accessgudid.nlm.nih.gov/ UDI
    https://www.federalregister.gov/documents/2016/06/15/2016-13989/use-of-symbols-in-labeling symbols
    https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095308.pdf  Labeling for Medical Devices 
    https://www.ecfr.gov/cgi-bin/text-idx?SID=8e904e6b7619c1acc6a7bb3b5d9b279b&mc=true&tpl=/ecfrbrowse/Title21/21cfr801_main_02.tpl Medical Device lableing


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    Caterina Puddu
    Malmesbury
    United Kingdom
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    Original Message


  • 6.  RE: disclaimer in an advert

    Posted 06-Sep-2017 08:03
    Thanks to all of you for your advise and comments.

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    Frank Wilmerstaedt
    Hamburg, Germany
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    Original Message


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