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 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 provides a general overview of the revised guidance document and highlights the key points related to the existing legal framework.
FDA
The new article pays attention to the general questions associated with Q-Submissions that medical device manufacturers may use to request additional feedback from the authority before submitting an actual application for marketing approval.
