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    Demonstration Kit

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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    • K
      KEOCA last edited by

      Demo syringes (with no active drug or placebo liquid) will be given to hcps who request to do their own injection training with patients rather than utilize the Patient Support Program to do so. The demo syringes will have a sticker that includes the brand name but identifies the syringe as a demo, for training purposes only. The syringe will come in a box with the brand name, which again will identify the syringe as a demo for training purposes only. The box will also include instructions of how to operate the demo syringe and these instructions were provided by the manufacturer of the demo syringe. This syringe is used by many other products so the instructions of how to operate the demo model (activation/ how to reset) will not be unique to the branded product. Does this box with its demo syringe and instructions require PAAB review? Our team is split on this and we would appreciate clarification. If this project does require PAAB review do we submit pdfs of the components as one file or as a series of related files? Thank you!

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @KEOCA last edited by

        HI @keoca

        This would be considered a service-oriented vehicle and would be subject to review as it is part of the HCP-patient interaction in the context of the brand. It could likely be submitted as one file.

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