Regulatory Open Forum

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  • 1.  Off-label Promotion

    Posted 14-Jun-2013 13:38

    You can certainly display a 510(k) for a cleared product at a meeting as you know, however, I would be very wary of displaying one where the indications are not cleared. I believe this could be considered off-label use promotion and not taken lightly by the FDA.

    Hope that helps.
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    Denise Hebert
    Regulatory / Medical Specialist
    Beaver-Visitec International, Inc (BVI)
    Waltham MA
    United States
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