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.
FDA
The new article provides a general overview of the Q-submission process as the relevant legislation prescribes.
FDA
The new article describes potential questions to be discussed with the authority in the context of the Q-Submission Program interactions.
FDA
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
FDA
The new article further elaborates on the scope of documentation to be provided concerning cybersecurity devices intended to be marketed and used in the US.
