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# Guidance on Device Q-Submission Program
- URL: https://www.fdaweb.com/guidance-on-device-q-submission-program/
- Published: 2019-05-06T12:00:00.000Z
- Updated: 2026-09-15T01:24:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144032

FDA has made available a [final guidance](https://www.fda.gov/media/114034/download?ref=fdaweb.com) entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document provides an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA about potential or planned medical device IDEs, PMAs, BLAs, HDEs, De Novo marketing requests, and 510(k)s, among other submissions. The guidance was mandated as part of the Medical Device User Fee Amendments of 2017, where industry and the agency 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.