Introduction of The Q-Submission Program by FDA
On May 15, 2020, CMDE released an introduction of the Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program issued by FDA on May 7, 2020. This guideline issued by FDA is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the FDA regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Premarket Notification (510(k)) Submissions, etc. CMDE is willing to learn from international advanced experience and working methods to improve the communication efficiency and shorten the evaluation time in the medical device evaluation process in China.
