By- Elle Winn (Mittal Consulting)

FDA Revamps Q-Sub Process with New Guidance and Digital Submission Template

On May 29, 2025, the U.S. Food and Drug Administration (FDA) released two significant guidances related to the Q-Submission (Q-Sub) Program for medical devices. These include the finalized guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” and a new draft guidance “Electronic Submission Template for Medical Device Q-Submissions.” These two guidances offer important information and clarity on the Q-Submission program and provide insight into upcoming changes that all medical device developers should be aware of.

Finalized Q-Sub Guidance: A Comprehensive Resource

The finalized Q-Sub guidance provides a detailed overview of the various Q-Submission types, including Pre-Submissions (Pre-Subs), Submission Issue Requests (SIRs), Study Risk Determinations, Informational Meetings, PMA Day 100 Meetings, and others. This document replaces earlier versions and reflects FDA’s continued efforts to streamline the feedback process for device development and regulatory strategy discussions.

Importantly, the guidance outlines key considerations for initiating a Q-Sub and walks sponsors through the entire Q-Sub process, from request generation to FDA review. One of the most helpful aspects of the guidance is its set of appendices, which provide clear examples and templates. These include acceptance criteria for Pre-Subs, sample Pre-Sub questions, and example meeting minutes—each offering critical insights that can improve the quality and clarity of sponsor submissions.

For those who are familiar with the draft Q-sub guidance from March 2024, there are not many big changes to be aware of. However, a noteworthy change in this final version is FDA’s clarification on meeting recordings. While FDA may record Q-Sub meetings for internal purposes, sponsors and other non-FDA attendees are explicitly prohibited from recording any audio or visuals.

Draft Guidance on eSTAR for Q-Subs: Moving Toward Mandatory Electronic Submissions

In tandem with the finalized Q-sub guidance, FDA also released a new draft guidance focused on the use of the electronic Submission Template and Resource (eSTAR) for Q-Submissions. This document, though brief, signals a major shift in how Pre-Subs will be submitted to the Agency.

Initially, use of the eSTAR template will be voluntary during a one-year transition period following the finalization of the draft guidance. After this period, however, use of eSTAR for Pre-Subs will become mandatory. The eSTAR template is designed to streamline submission generation through a structured format that includes logic-based prompts, dropdown menus, text boxes, and attachment fields.

Currently, the eSTAR template is focused on Pre-Subs (referred to as the PreSTAR). The guidance provides a quick overview of included sections within the PreSTAR, including:

• Indicating which submission type is being used (pre-submission)
• Cover letter, letter of references
• Applicant and correspondent details
• Discussion of prior regulatory interactions
• Consensus standards
• Submission goals
• Product description
• Proposed indications for use
• Device classification
• Labeling
• Literature references
• Pre-submission questions
• Related amendments

While FDA has not identified any instances where the eSTAR requirements for Q-Subs will be waived at this point, FDA has noted that some pre-sub components may be eligible for exceptions from the eSTAR requirement for Q-Subs, including responses to additional information requests and a variety of amendments.

Conclusion

Together, these guidances mark an important evolution in FDA’s Q-Submission Program. By finalizing the broader Q-Sub process guidance and introducing the structured eSTAR format, FDA is providing sponsors with additional clarity on the expectations and processes involved in the Q-Sub program. Additionally, continued development of the Q-Sub program demonstrates FDA’s intention to continue utilizing Q-Submissions which has been a question for many stakeholders during recent changes in FDA and HHS under the new administration. Overall, becoming familiar with these updated guidances can help ensure successful and compliant interactions with the Agency through Q-Subs moving forward.