Unauthorized Use of Content on this Site: 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 correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
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?
-
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.
