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
EU
The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.
Canada
The article highlights the critical points of managing new submissions related to the products intended to be placed on the Canadian market.
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