The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
560 - As follow-up to Questions 291/328/500, would medical device (class II)-sponsored advertising be subject to PAAB review, if comparisons were made between the medical device and a non-medical (drug-containing) device?
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It is our understanding that you wish to compare features of a drug-delivery system for a class II medical device and a drug-delivery system which is not classified as a medical device. The latter cannot be presented as a stand-alone device, but must be presented in the context of the drug & device. Although it may be possible to make non-therapeutic comparisons of the device features, the content is subject to the PAAB code provisions.
