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  • 1.  Research Use Only (RUO)

    Posted 01-Aug-2012 16:44

    With the proper disclaimer: "For Research Use Only. Not for use in diagnostic procedures," can a company exhibit RUO products at a booth at trade shows in the United States? Or would that be giving the false impression that the product is being sold for IVD use?


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    Dana Tasic JD
    Senior Regulatory Affairs Associate
    Los Altos CA
    United States
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  • 2.  RE:Research Use Only (RUO)

    Posted 02-Aug-2012 10:45
    Dana:

    In response to "can a company exhibit RUO products at a booth at trade shows in the United States? Or would that be giving the false impression that the product is being sold for IVD use?"

    Yes!  I am inferring that you may have a flyer listing your products with "RUO" and "Not for use in diagnostic procedures."

    PLEASE consider the following as my "Cautionary Notes" or "DON'Ts" if you will.    

    Labeling goes far beyond what we normally perceive including "words" or "acts."  "Intent" can be shown by "words" or "acts" too.  

    The following four (4) examples may/can reveal "evidence of intent" to promote your RUOs for IVD purposes. 

    - In your booth, if you say "our products are RUOs, but they work well in clinical samples and/or perform better than other similar IVD products." 
    - If you list your RUO products right next to an equivalent/similar IVD(s) with additional indications (e.g., technically expanding the indications of the said IVDs).
    - If you sell and/or ship RUO products to a clinical laboratory (e.g., CLIA certified).
    - If you present/demonstrate your RUOs in a meeting only for clinical folks and labs, knowing they don't do/perform any research.  
    Etc.
     
    DOs

    -Our RUO products are for Research Use Only and Not for IVD purposes.
    -We do NOT sell our RUO products to a clinical lab.  
    -We sell ASRs to a clinical lab(s) (CLIA certified) with proof of certification.
    -If and when we learn "our RUO products" are about to be used for IVD purposes, we IMMEDIATELY cease selling and/or shipping and take an action (e.g., corrective action).
    -If proper and necessary with documented justification, we even request the return of our RUO products for a refund for violating our "LABELING."  


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    www.RegulatoryDoctor.com
    Floyd VA
    United States
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