Regulatory Open Forum

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  • 1.  Marketing Video

    Posted 30-Dec-2015 17:03

    My company is getting ready to release its first Marketing Video and we do not currently have a process in place to be able to control and release videos.  The video is a surgery using our implants and instruments that is narrated by a surgeon.  I am looking for others input on best way to control a marketing video and what does the FDA require?

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    Bobbi Siddoway
    Regulatory Specialist
    Salt Lake City UT
    United States
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  • 2.  RE: Marketing Video

    Posted 01-Jan-2016 03:33

    There are many ways to handle approvals of marketing materials.  The easiest way is releasing it like any other labeling. This way the content is reviewed/signed-off through your change control system by the appropriate personnel (e.g. Regulatory, Clinical, etc.) without much change to your Quality System. 

    Regarding review of content, I find this useful as to understand what FDA is looking for: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm155480.pdf

    Hope that helps!

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    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA

    Original Message


  • 3.  RE: Marketing Video

    Posted 01-Jan-2016 14:47
    Bobbi,

    Clarisa offered good info.

    If you are willing to further consider, you may refer to the following seminar.


    Quite a few videos on YouTube failed to meet FDA's enforcement policy and perspectives. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 4.  RE: Marketing Video

    Posted 21-Jan-2016 09:08
    Bobbi,

    On Jan 1, 2016, I stated "Quite a few videos on YouTube failed to meet FDA's enforcement policy and perspectives."

    A giant in pharma industry was recently hit with an untitled letter from FDA, dated Jan 14, 2016, for YouTube video.  

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message