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# Q-Submission Guidance
- URL: https://www.fdaweb.com/q-submission-guidance/
- Published: 2021-01-05T12:00:00.000Z
- Updated: 2026-09-14T16:41:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148370

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](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program?utm%5Fmedium=email&utm%5Fsource=govdelivery) 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.