FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
FDA
The new article describes in detail the approach the authority applies when reviewing De Novo requests about medical devices utilising novel technologies.
FDA
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
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 current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
