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.