HSA
The new article clarifies the scope of information to be included in the submission to ensure all the essential matters are adequately addressed, the submission is complete, and the authority has all the necessary information to make the regulatory decision.
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.
