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.
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
United States
The article describes in detail the approach to be applied with respect to non-clinical bench testing medical devices should undergo in order to collect necessary safety data to support the relevant claims included in the premarket submission.
