Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

In which section of the ICH Common Technical Document will the overview of clinical data appear?

Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?