BfArM
The new article highlights the key points related to the studies to be carried out to demonstrate a positive supply effect.
BfArM
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
FDA
The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
