How to handle an APS that includes exempt medical device messages and HCP messages that require PAAB review
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Based on previous replies regarding Class III medical devices we are aware that PAAB does not review pieces that are limited to the device itself and the advertising of such devices is governed by MedTech Canada (formerly MEDEC), however I am wondering if we wanted to include information about a medical device in an APS along with messages that PAAB has previosuly reviewed and approved would the new APS need to be submitted to PAAB if the new content is limited to advertising the device, which is outside PAAB's scope? Furthermore if PAAB would need to review this message, what type of support is requires for messages relating to device as they don't have a PM to reference, or would PAAB not require any reference?
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Hi @smurcar
The addition of such content would prompt a new review as you are changing the piece.
While Class I-IV medical devices do not fall under the scope of PAAB review, the piece in question combines drug-related content and device-specific content. Any change to the former OR the latter would trigger the requirement for re-assessment. Changes in the device-specific content could potentially impair acceptability of the previously approved drug content through various contextual or linkage factors. Based on the information provided in the question, some of the key focuses of our review might include:
- Whether the added content is indeed device-specific.
- Whether the drug-related and device-specific content are separate and distinct from each other. For example, the device-specific content must not impact the meaning/interpretation of the drug content through context or linkage.
- Whether the device-specific content suggests therapeutic outcomes or contains promotional claims for the drug brand. For example, if the claim was to state “Drug Brand X: pain free injections with S-pen”, we would question the link between the drug brand and “pain” in the absence of support. For copy to be considered “device” claims, it should be limited to the device and not positioned as a feature of the drug brand.
As the assessment is largely contextual in nature, references are not typically required for the Class I-IV medical device-specific content. Particularly as the manufacturer is solely responsible for ensuring that the medical device claims adhere with all applicable marketing rules and regulations. The reviewer will request references, on an as needed basis, wherever this content could potentially relate to the drug product.
