Brief · Use case · Regulatory
SaMD Submission Plan.
LivePlanPlan the FDA submission and pivotal evidence for an AI diabetic retinopathy device, with the external clocks and the first move.
SaMD Submission Plan is a ready-made use case for Regulatory. It ships under the Plan template.
For regulatory and clinical leads. You get the objective, finish and critical path, the milestones with exit criteria, the agency clocks you cannot control, the gates and what could derail the plan. Durations are cited, marked as estimates or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
What is the plan for the regulatory submission and pivotal evidence generation for an AI-based software medical device that flags diabetic retinopathy, from today to FDA marketing authorization?
The steps of the plan
FDA publishes the clocks it works to. The plan builds its sequence on those clocks and keeps your own work apart from them.
| Step | What it involves | The clock or source |
|---|---|---|
| Ask FDA for feedback | A Q-Submission is voluntary. FDA acknowledges within 15 calendar days and, under its MDUFA V goals, provides written feedback within 70 calendar days of receipt, or five days before a scheduled meeting if that is sooner. FDA recommends only one Q-Submission at a time for a device.1,2 | The MDUFA V performance goals and FDA’s Q-Submission guidance, final May 2025. |
| Generate the pivotal evidence | The evidence plan agreed with FDA and the analysis that supports the claim. This step is yours and has no external clock. | Your own evidence plan; durations marked as estimates. |
| File the submission | A 510(k) against a predicate or a De Novo request. The standard fees for fiscal year 2027 are $28,653 for a 510(k) and $191,020 for a De Novo request.3,4 | FDA’s program pages and fee schedule. |
| FDA review | FDA’s goals are a decision for 95 percent of 510(k) submissions within 90 FDA days and for 70 percent of De Novo requests within 150 FDA days. FDA days count only the time a submission is with the agency. The total-time goal for 510(k)s received in fiscal years 2025 to 2027 is 112 calendar days.1 | The MDUFA V performance goals. |
What the plan does
FDA days are not calendar days. The goals are expressed in FDA days, which exclude the time a submission waits for the sponsor. The plan keeps the two apart, so a request for more information appears as time on your side of the clock.1
Goals are shares, not promises. The MDUFA goals are targets for a share of submissions, not a guarantee for yours. The plan carries contingency and says why.1
The route is a gate. The choice between a 510(k) and a De Novo request depends on whether a predicate exists, so the plan puts the predicate check ahead of the evidence work and says what changes if it fails.3
AI-enabled software adds a document. FDA’s January 2025 draft guidance on AI-enabled device software functions describes what a marketing submission should contain. The plan reads it, says it is a draft, and adds its expectations to the evidence work.5
Recommended length
Comprehensive
Several parties are involved and decisions have to be taken along the way. Comprehensive adds the gates, the responsibility table and the risk map.
You can pick another length on the form. The other two stay available.
Assumptions the plan checks
The plan states the assumptions its dates rest on and says which one would move the finish if it failed. Examples for this plan:
- A predicate exists, or the plan switches to a De Novo request at the gate.
- FDA’s feedback arrives within its stated goal and the evidence plan does not change.
- The submission is accepted without a request for more information.
Standards, guidance and sources
FDA clocks and routes
- MDUFA performance goals and procedures, fiscal years 2023 through 2027.1
- FDA, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, final guidance, May 2025.2
- FDA, Premarket Notification 510(k) and De Novo Classification Request, and the fiscal year 2027 fee schedule.3,4
- FDA draft guidance on AI-enabled device software functions, January 2025.5
The decision practice behind the memo itself is on the template page.
What gets flagged
Any duration that is an estimate, any step whose clock is in FDA days and not calendar days, and the predicate check if it is not complete.
What arrives
- The objective
- The sequence
- Gates and decisions
- Who is needed
- Dependencies and external clocks
- What could derail it
- The first move
What it will not do
It does not promise dates. Each duration is sourced or marked as an estimate, and an unpublished deadline is a gap.
It does not predict FDA’s decision or the date of it.
It does not guarantee the dates. The durations are sourced or marked as estimates, and the plan says which.
It does not invent an agency’s deadlines. A deadline that is not published is a gap.
It does not run the plan. It gives an owner the first move and the criteria for the next gate.
References
- [1] U.S. Food and Drug Administration. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027. Read on 9 October 2026: 510(k) 90 FDA days for 95 percent; De Novo 150 FDA days for 70 percent; pre-submission written feedback within 70 calendar days; 112-day total-time goal for 510(k)s in fiscal years 2025 to 2027.
- [2] U.S. Food and Drug Administration. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Final guidance, May 2025. Status and date as given in FDA’s guidance listings found by search; the guidance text was not read.
- [3] U.S. Food and Drug Administration. Premarket Notification 510(k) and De Novo Classification Request pages. Last updated 22 August 2024 and 30 September 2025. Both pages were read on 9 October 2026.
- [4] U.S. Food and Drug Administration. Medical Device User Fee Amendments (MDUFA): Fees. Fiscal year 2027 amounts. Fees change each fiscal year. Check the page for the year of your submission.
- [5] U.S. Food and Drug Administration. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. Draft guidance, January 2025. Docket FDA-2024-D-4488. Draft, not for implementation. Check whether it has been finalized.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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