FDA
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
FDA
The new article further elaborates on the scope of documentation to be provided concerning cybersecurity devices intended to be marketed and used in the US.
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.
FDA
The new article describes in detail the aspects of the different types of interactions with the authority within the Q-Submission concept, emphasizing their specific features and use cases
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