Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Promotion on use of device, but not medication nor disease
-
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 -
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?
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
