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  3. Promotion on use of device, but not medication nor disease
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

Promotion on use of device, but not medication nor disease

Scheduled Pinned Locked Moved PAAB Q&A
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  • NatBourreN Offline
    NatBourreN Offline
    NatBourre
    wrote on last edited by
    #1

    A client has a device that they use in combination with several of their medication products. They want to train HCPs on how to use the device, without ever mentioning any product (no brand, no therapeutic category, no generic names) and no disease states. For example, they would mention to place the device in dominant hand, push this button, wait for click, etc... Does the client need to submit this type of training for PAAB review?

    Natalie Bourré
    Marketing 4 Health Inc.
    Medical Marketing Consultant, Medical Writer
    nat@marketing4health.net

    Yin ManY 1 Reply Last reply
    0
    • NatBourreN NatBourre

      A client has a device that they use in combination with several of their medication products. They want to train HCPs on how to use the device, without ever mentioning any product (no brand, no therapeutic category, no generic names) and no disease states. For example, they would mention to place the device in dominant hand, push this button, wait for click, etc... Does the client need to submit this type of training for PAAB review?

      Yin ManY Offline
      Yin ManY Offline
      Yin Man
      wrote on last edited by
      #2

      @natbourre

      Thanks for your question.

      If the device is a distinct Class I-IV “medical device”, it does not fall within the PAAB scope as defined in code section 1.3 and the definition of a “Health product” per PAAB scope in section 1.8.

      If it is not a Class I-IV “medical device” and is an extension of the corresponding drug product, then the training material, directed to HCPs, would be subject to PAAB review.

      Please also see PAAB Q&A #500 as well as this PAAB Forum post

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