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 provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.
FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
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.
