Pre-Submission

Context and purpose

A Pre-Submission, Pre-Sub for short, is a voluntary written request to the US regulatory authority FDA. With it, a manufacturer obtains feedback on specific questions before a planned submission. The basis is the guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”. The version dated May 29, 2025 is the relevant one; it replaces the version of June 2023 (as of October 2026). Like all FDA guidances, it contains only non-binding recommendations.

Q-Submission, Q-Sub for short, is the umbrella term for the system the FDA uses to track the various forms of interaction with manufacturers. Besides the Pre-Sub, it includes Study Risk Determinations and Informational Meetings, among others.

A Pre-Sub can relate to various later submissions, for example a 510(k) Premarket Notification, a De Novo request, a PMA application, or an Investigational Device Exemption (IDE) application for a clinical study. According to the guidance, the feedback is meant to guide product development and the preparation of the submission. In the FDA's experience, feedback works best when it is obtained before planned studies are conducted. For usability engineering, this means: the right time is before human factors validation, not after it.

Process: written feedback and meeting

When submitting the request, the manufacturer chooses between two forms of feedback: written feedback only, or written feedback followed by a meeting. The meeting usually takes place virtually; an in-person meeting is possible on request. It is normally limited to one hour.

The process consists of five steps:

• Submission: The request is submitted electronically in English. An electronic template called PreSTAR is available for Pre-Subs. Its use is voluntary (as of October 2026).
• Acceptance review: The FDA uses a checklist to determine whether the request is suitable as a Pre-Sub and complete. For PreSTAR, a technical screening takes the place of this step. If something is missing, the request is put on hold (Refuse to Accept). After the missing items are provided, the count starts again at day 0.
• Written feedback: The FDA answers the questions in writing by email.
• Meeting: If a meeting was requested, the discussion is based on the written feedback. If the feedback already answers all questions, the manufacturer can cancel the meeting.
• Minutes: The minutes of the meeting (meeting minutes) are prepared by the manufacturer, not by the FDA. The manufacturer submits them as an amendment to the Pre-Sub.

New information that the manufacturer submits between the feedback and the meeting is generally not commented on by the FDA, because there is not enough time for a thorough review. A further Pre-Sub as a supplement serves this purpose.

Timelines under the Q-Submission guidance

The guidance names timelines the FDA aims to meet. These are based on MDUFA V, the Medical Device User Fee Amendments of 2022. Days are counted as calendar days from the start of the review clock (as of October 2026):

• Acceptance review or technical screening: within 15 days.
• Agreement on a meeting date: within 30 days. If this does not succeed, an FDA manager gets in touch by day 40.
• Written feedback without a meeting: within 70 days.
• Written feedback with a meeting: at least 5 days before the meeting and no later than day 70.
• Meeting: by agreement, typically between day 70 and day 75.
• Draft minutes from the manufacturer: within 15 days after the meeting. If the FDA changes the draft, it sends back its version within 30 days. This version becomes final 15 days later unless the manufacturer objects.

For project planning, this means: between an accepted request and the written response, up to 70 days, that is ten weeks, can pass. This lead time should be planned in before recruitment and test dates.

Content and suitable questions

Besides contact details and the desired form of feedback, a Pre-Sub mainly contains: purpose and desired outcome, a device description, the proposed indications for use, the regulatory history, the planned follow-on submission, background material, and specific questions. As background material, the guidance mentions, for example, literature, technical drawings, drafts of the labeling, videos, and revised protocols.

The FDA recommends a clear limit: no more than three to four substantive topics and a total of seven to ten questions, including sub-questions. If there are too many topics, the FDA can ask for prioritization and refer less urgent topics to a later Pre-Sub.

Suitable questions present a specific proposal with a rationale and ask whether the FDA considers it appropriate. The FDA does not design studies. According to the guidance, unsuitable questions are open-ended requests for “further feedback”, a request to dictate a study design, questions about the outcome of a later submission, and requests for a formal regulatory decision. Whether a particular product qualifies as a predicate device, on the other hand, can be the subject of a Pre-Sub. Questions about classification belong in a separate request under Section 513(g) of the Federal Food, Drug, and Cosmetic Act, the US law governing food, drugs, and medical devices.

Human factors in the Pre-Submission

For human factors engineering, the Pre-Sub is the instrument named by the FDA itself. In the FDA human factors guidance (“Applying Human Factors and Usability Engineering to Medical Devices”, version dated August 3, 2026), the FDA encourages manufacturers to submit a draft of the test protocol before conducting the test. This allows it to assess whether the planned methods are acceptable. It expressly names the Pre-Submission as the route for this.

Appendix 2 of the Q-Submission guidance lists example questions on human factors. In essence, they read:

• Is the attached test protocol suitable for collecting safety data for the later submission?
• Is the plan for the use-related risk analysis (URRA) appropriate, and does the FDA see additional critical tasks that should be considered?
• Is the recruitment plan for the participants in the human factors validation appropriate?

This yields typical topics that can be agreed with the FDA in advance:

• Critical tasks: IEC 62366-1 works with hazard-related use scenarios, the FDA with critical tasks (FDA term). Because the FDA expects all critical tasks to be performed in the validation, it is worthwhile to present the list and its derivation from the risk analysis early.
• Number of participants and user groups: As a rule, the human factors guidance calls for at least 15 participants per distinguishable user group. Whether the groups are properly delineated and the sample reflects the representative users is a suitable question for the recruitment plan.
• Participants outside the US: According to the human factors guidance, participants should live in the US. The FDA reviews exceptions case by case on the basis of a sound rationale that takes into account the differences from conditions in the US. Anyone who wants to test in Europe, for example, should submit this rationale in advance in a Pre-Sub. The Q-Submission guidance generally recommends considering submitting the entire protocol for studies conducted outside the US that are meant to support a submission.
• Scope of the human factors data: The guidance “Content of Human Factors Information in Medical Device Marketing Submissions” (final version dated May 29, 2026) describes when a rationale can suffice instead of new validation data. If it is unclear whether such a rationale holds up, the FDA recommends obtaining feedback through a Pre-Sub.

The FDA's human factors validation corresponds in its position in the process to the summative evaluation under IEC 62366-1, but is not identical to it. Anyone planning one study for both markets can turn the differences into specific questions. It helps to supply your own proposal with a rationale for each question, for example the derivation of the user groups from the user profile.

What a Pre-Submission does not provide

A Pre-Sub is not a preliminary review. The guidance makes clear that it is neither a preliminary review of the planned submission nor of the data it contains. Results of a human factors validation that has already been conducted therefore cannot be confirmed in advance. What is possible, however, is a targeted question on interpreting preliminary results that are hard to interpret, or on the planned handling of them in the submission.

The feedback is also not a commitment. Review of a Pre-Sub does not guarantee a favorable decision, and further questions may arise with the later submission. Topics that were not asked about in the Pre-Sub may still require evidence later. However, the FDA intends not to change its feedback as long as the later submission is consistent with the information in the Pre-Sub and no significant new findings on safety or effectiveness are available. If the manufacturer substantially changes the intended use, technology, or labeling, the FDA may adjust its feedback. For usability engineering this is relevant because the instructions for use are also part of the labeling.

If the feedback on the study design is more than one year old and the study has not yet begun, the FDA recommends asking whether the advice still applies. If the manufacturer deviates from the feedback, it should explain this in the submission. The submission should list earlier Q-Subs and describe how the feedback was implemented. For the human factors documentation, it makes sense to establish this reference in the HFE/UE report as well.

Frequently asked questions (FAQ)

Sources

• FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices
• FDA Guidance: Content of Human Factors Information in Medical Device Marketing Submissions
• IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
• FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• FDA: eSTAR Program

Related terms

• Human factors validation testing
• FDA human factors guidance
• Critical task
• Use-related risk analysis (URRA)
• Representative users
• HFE/UE report (human factors report)
• Summative usability evaluation

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