FDA
The new article outlines the general considerations associated with the Q-Submission Program to facilitate the process of obtaining feedback from the authority concerning regulatory submissions.
FDA
The new article provides a general overview of the Q-submission process as the relevant legislation prescribes.
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 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.
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