FDA Draft Guidance on Section 524B: Specific Aspects
The new article provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.
The new article provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.
The article highlights the critical points related to the regulatory status of certain software products.
The new article provides an in-depth overview of the problems identified and solutions proposed by the authority, together with the questions to be answered by the key stakeholders.
The article provides a general overview of the revised guidance document and highlights the key points related to the existing legal framework.
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.
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