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# FDA Guide on Requesting Feedback on Device Submissions
- URL: https://www.fdaweb.com/fda-guide-on-requesting-feedback-on-device-submissions/
- Published: 2017-10-02T12:00:00.000Z
- Updated: 2026-09-14T22:53:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139762

FDA has made available a [guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf?ref=fdaweb.com) on “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.” The document provides an overview of the mechanisms available to applicants to request feedback from the agency a potential medical device submission. It covers information regarding the logistics for submission, receipt, tracking, and the review of suchrequests. FDA says that the requests for feedback will now be collectively referred to as “Q-Submissions” or “Q-Subs.” Additionally, the guidance provides clear recommendations for applicants regarding the appropriate preparation for, and conduct of, meetings with agency staff.