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# Updated Draft Q-Submission Guidance
- URL: https://www.fdaweb.com/updated-draft-q-submission-guidance/
- Published: 2024-03-14T12:00:00.000Z
- Updated: 2026-09-14T14:25:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156554

FDA has published an updated draft guidance, *Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program*, giving an overview of the mechanisms available to submitters through which they can request interactions with FDA related to 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-draft-guidance?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the interactions can include written feedback and/or a meeting related to potential or submitted medical device applications.

In an online [post](https://content.govdelivery.com/accounts/USFDA/bulletins/39053b7?ref=fdaweb.com), the agency says the updated draft provides:

information to assist applicants in identifying when an informal communication would generally be appropriate instead of a pre-submission or other Q-Submission type;

- additional information on the scope of Q-Submission types, as well as clarifications to existing policies and procedures;
- content from *Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry*, with no changes to existing policies and procedures for PMA Day-100 meetings; and
- revised examples of common review topics and questions.

Comments on the updated draft will be accepted until 5/14.