EU
The article provides a general overview of the approach to be followed when creating a clinical investigation plan for medical devices.
EU
The new article outlines the scope of general information to be covered by a clinical investigation plan a party responsible for the inquiry should prepare.
EU
The new article describes the way study benefits and objectives should be reflected in a clinical investigation plan.
EU
The new article provides additional clarifications regarding study design and data management aspects.
FDA
The new article outlines the general considerations associated with the Q-Submission Program to facilitate the process of obtaining feedback from the authority concerning regulatory submissions.
