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.
United States
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
