Promotion on use of device, but not medication nor disease
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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?
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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
