Q-Submission Guidance

FDA has published a guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on various types of potential or planned medical device submissions. The document says the pre-IDE program was established in 1995 and later evolved to include feedback on PMAs, HDEs, De Novo requests, and 510(k) submissions, as well as to address whether a clinical study requires submission of an IDE.

A 2014 guidance implemented the broader Q-Submission program, FDA says. Under MDUFA 4, FDA and industry agreed to refine the Q-Sub program with changes related to the scheduling of pre-submission meetings and a new performance goal on the timing of FDA feedback for pre-submissions. FDA says the current guidance reflects those changes and clarifies other elements of the Q-Sub program.