Demystifying the FDA Q-Sub Process for Human Factors Deliverables
Mar 11, 2025
Demystifying the FDA Q-Sub Process for Human Factors Deliverables
For medical device manufacturers (Sponsors), navigating FDA's Q-Submission (Q-Sub) process to secure FDA input on proposed Human Factors Validation Studies or other Human Factors Engineering (HFE) deliverables can seem daunting. However, when used strategically, this voluntary process can provide invaluable feedback before your formal submission. This article breaks down some important concepts related to the Q-Sub process for HFE deliverables and offers practical guidance for obtaining maximum benefit during this time of flux at FDA.
Understanding the Q-Sub Process
The Q-Sub program provides manufacturers an opportunity to engage with CDRH or CBER through informal meetings and/or written correspondence before formal device submissions. Notably, Q-Subs are not used for communications with CDER. These communications are governed by a different FDA Guidance. [4] For Human Factors, this interaction is particularly valuable as it can help confirm if the agency agrees with your testing approach or justification and identify potential concerns well in advance of the final regulatory submission with FDA.
The process typically follows these key steps:
1. Pre-submission Planning
Define the goals of the FDA interaction.
Identify specific questions and topics requiring FDA input.
Gather and prepare relevant documentation and preliminary data.
Determine the optimal timing in your development cycle based on expected response times.
2. Q-Sub Preparation
Draft a comprehensive Q-sub package, including Q-sub coversheet.
Include background information to help FDA understand the purpose of the Q-sub (e.g., a new or updated Human Factors Validation Protocol review, a justification for why you can leverage Human Factors Validation testing for a previous product or from one user group for another).
Prepare key documentation you want reviewed (e.g., Protocol, Use-Related Risk Analysis, Moderator's Script, IFU).
Identify key subject matter expert(s) (e.g., human factors) from FDA that need to be in attendance at a meeting (review).
Present your position with supporting reasoning.
Clearly articulate your questions to FDA in order to confirm agreement with your proposed approach.
3. FDA Review Period
FDA assigns appropriate reviewers.
FDA and Sponsor agree on meeting time/date, as applicable – see Table 1 below for typical timelines.
Internal FDA review and discussion.
Preparation and delivery of written feedback from FDA, if applicable.
4. FDA Meeting (if applicable)
FDA and Sponsor hold a 1-hour meeting for discussion of FDA feedback.
Sponsor provides draft meeting minutes to FDA within 15 days.
FDA provides feedback on minutes.
FDA and Sponsor agree on finalized minutes.
5. Feedback Integration
Consideration and integration of FDA feedback into your Human Factors deliverable and/or program, as appropriate.
Table 1: Expected Typical Timelines Presented in FDA Guidance
* Timelines were gathered from FDA Guidance. [1, 2, 3]
Navigating Current Regulatory Uncertainty
In the current climate of regulatory evolution at the FDA, manufacturers should approach Q-Subs with additional strategic considerations:
Timeline Adjustments
Build extra buffer time into your development schedule to manage potential changes in the regulatory landscape.
Anticipate potential delays in FDA response times. From what we have seen and heard, they are currently trying to adhere to timelines presented in their guidance [1]; however, there may be further delays since staff are prioritizing Medical Device User Fee and Modernization Act (MDUFMA) paid activities. Depending on how each division’s resourcing has been impacted and the current review load, accelerated timelines granted for Sprint discussions in the Breakthrough and STeP programs described in guidance [2, 3] may be impacted more greatly.
Plan for possible follow-up interactions if all of your questions are not addressed.
Strategic Communication
Frame Q-Sub questions to explicitly acknowledge areas of uncertainty. Avoid unnecessary questions that may divert the focus away from important points for FDA feedback.
Maintain regular communication with your review division before and after the Q-Sub.
Information Gathering
Stay informed about recent similar product reviews and publicly available information.
Monitor changes in FDA priorities, changes in personnel or guidance, and industry trends.
Network with industry peers about their recent regulatory experiences.
Documentation Practices
Document all FDA interactions thoroughly and promptly.
Maintain comprehensive records of all advice received.
Create clear traceability between FDA feedback and your implementation actions.
These practices can help you navigate this period of regulatory flux.
Conclusion
The Q-Sub process represents a valuable opportunity to gain FDA insight before formal submission. While it requires significant preparation, the potential to identify and address concerns early in development can save substantial time and resources. By following this structured approach and thorough preparation, teams can maximize the benefits of the Q-Sub process for their Human Factors programs.
Remember that while the Q-Sub process is voluntary, it's particularly valuable for novel devices, complex use environments, or when proposing approaches that deviate from standard FDA Guidance. The investment in preparation and engagement with the FDA through this process can smooth the path to eventual approval.
In our next article, we'll explore key topics that benefit from FDA pre-review and provide preparation checklists for your team.
References:
FDA Guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” June 2,2023.
FDA Guidance, “Breakthrough Devices Program,” Sept 15, 2023.
FDA. Guidance, “Safer Technologies Program for Medical Devices,” Jan 6, 2021.
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. Guidance for Industry (Draft). FDA. September 2023
