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  • 1.  Off-label promotion

    Posted 13-Jun-2013 13:43
    Can a device company physically display a 510k cleared product at a meeting which is not relevant to that cleared product indications? Please share your thoughts. ------------------------------------------- Chandar Thakur Columbia MD United States -------------------------------------------


  • 2.  RE:Off-label promotion

    Posted 13-Jun-2013 19:32
    Interesting question. 

    I would argue that, as long as you restrict your written and verbal statements to the cleared indications, you are technically acceptable.  However, you might attract attention to the fact that your product might be used off-label and, if there are any safety issues associated with that off-label use, FDA has the authority to seek to require that you amend your labeling to make clear that the device should not be used for the off-label use.


    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
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    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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  • 3.  RE:Off-label promotion

    Posted 14-Jun-2013 13:45
    The display itself is an advertisement.  In the purest sense Michael is right.  However a display in an area which is unrelated to the intended use of the product is difficult to explain to a regulatory authority.  One can simply ask "what is the intent of the display?'

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    Robert Schiff PhD, FRAPS, RAC
    President and CEO
    Schiff & Company, Inc.
    West Caldwell NJ
    United States
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  • 4.  RE:Off-label promotion

    Posted 17-Jun-2013 15:39

    Chandar,
    I would add the following 3 points to Michael's argument about being "technically acceptable."
    Is it OK for a manufacturer to display a device at a meeting, where Indications For Use not FDA-cleared for the device are being discussed?

    1. Do consider FDA's use of the "Net Impression" factor (also used by FTC to determine whether the consumer is likely being misled), when evaluating risk communication in a promotional piece, i.e. Net Impression = the message communicated by all elements of the piece as a whole.  Is the whole conveying an accurate and non-misleading impression of the benefits and risks of the promoted product?

       

      REF.: May 2009 FDA Draft Guidance "Presenting Risk Information in Prescription Drug and Medical Device Promotion." (page 4)

    2. Although applied specifically to IVD Devices, do consider how FDA assesses certain marketing practices as "evidence of an intended use that conflicts with [...] labeling." FDA believes that Intended use may be shown by the "circumstances surrounding the distribution of the product." In addition, if a company is further well aware that its device is being used off-label for the indications under discussion in the meeting, FDA will consider this "manufacturer's knowledge", as well as the manufacturer's provision of technical support for such off-label activities, as "EVIDENCE" that the product is intended to be used for such purposes. (The weight of this evidence will vary with the circumstances, and that's when the lawyers get hired.)

       

      REF.: June 2011 FDA Draft Guidance "Commercially Distributed IVD Products labeled for RUO or IUO: Frequently Asked Questions." (page 10, Section B. Question 2)

    3. So, under the guise of being "technically OK", you might say, I'm not providing tech support for off-label uses of my device, and if FDA shows-up at my booth and questions me, I'll say that I had no idea my device was being used off-label for such indications discussed at the conference, and I did not at all intend to mislead conference attendees by displaying my device.  Maybe, you would be better off asking your lawyer to come-up with a good "justification" of why you're displaying your device in such an Off-Label type of environment!

    Regards,

    -------------------------------------------
    Ana Moura, MS, RAC
    Senior Specialist, Regulatory Affairs
    Celera, a Quest Diagnostics Company
    Alameda, CA, United States
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    Original Message


  • 5.  RE:Off-label promotion

    Posted 17-Jun-2013 17:50
    Folks:

    Ana has but the "meat on the bones" to my point.  She gives several  citations as to why you might want to avoid this concept.  Even if one could make the argument that the practice is acceptable, it begs more negative attention than that which is likely to benefit the the exhibitor.

    Michael


    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
    San Diego, CA 92101-4681
    P: +1 619 744 2215
    F: +1 619 923 2648
    C +1 760 815 4762
    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

    Please follow me on LinkedIN and Twitter:
    http://www.linkedin.com/in/michaelswit
    https://twitter.com/FDACounsel

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