Support for demo device instructions

[Username]

Hello, what kind of support would be required to support the instructions for a demo device (e.g., inhaler or self-injector)? Would a letter from medical confirming that these instructions are accurate for the demo deice suffice?

[Jennifer Carroll]

Good Morning @username

To set the context of the response, please see Q&A 500 . If the copy falls outside of the scope of the PAAB code, we can provide an advisory response on content. To support instructions for a demo device, we could consider a letter from medical confirming that the instructions are accurate per how they would counsel an HCP should they contact medical for directions on use. No copy should contradict the product labelling or package insert and clinical conclusions should not be inferred.