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
United States
The article highlights the critical points of the regulatory approach concerning specific medical devices intended to be marketed and used in the Philippines.
FDA
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
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