FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
FDA
The new article highlights the aspects related to the review process itself.
FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
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.
