Panel · Use case · Regulatory
Submission Strategy Red Team.
LiveRed Team ReviewStress-test an FDA submission strategy for an AI software device from regulatory, quality, digital and safety angles.
Submission Strategy Red Team is a ready-made use case for Regulatory. It ships under the Red Team Review template.
For regulatory leads. You get the position under test, a verdict, the challenges by angle, which survive, what would have to be true and where the strategy is weakest. Claims are cited 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
Where does the regulatory submission strategy for an AI-based software medical device fail, before it is sent to FDA?
Who attacks
FDA has issued guidance on what to include in a marketing submission for AI-enabled device software, including a plan for changes after authorization.
| Seat | How it attacks | What it works from |
|---|---|---|
| VP Global Regulatory Strategy | Pathway choice, predicate or classification arguments and the content of the submission.1 | FDA’s guidance for AI-enabled device software functions. |
| Director Quality Assurance | Quality system gaps, software lifecycle and change control.2 | The quality system regulation as it applies to devices. |
| Head of Digital Therapeutics | Whether the performance claims survive real-world use and drift. | Validation and monitoring practice. |
| Head of Pharmacovigilance | Post-market surveillance and how adverse events would be detected and reported. | Device vigilance practice. |
What the red team does
Change is part of the product. An AI model may change after authorization. The red team checks whether the strategy has a plan for changes that FDA can accept, and what it would cost if it does not.1
Quality system readiness. The quality seat tests whether the software development controls match what an inspection would expect.2
Tripwires after launch. The report lists the performance signals that would force a change and how each is monitored.
Recommended length
Standard
Four angles can break this plan. Standard depth gives each a seat, scores the challenges and lists mitigations and tripwires in about four pages.
You can pick another length on the form. The other two stay available.
Assumptions the red team tests
The red team lists the assumptions the plan relies on and says what would break each. Examples for this plan:
- The device is classified at the level the strategy assumes.
- The training data represent the intended population.
- Planned model updates fit within the agreed change plan.
Standards, guidance and sources
Frame
The decision practice behind the memo itself is on the template page.
What gets flagged
Any claim about the final or draft status of a guidance that was not checked, any performance claim from one dataset, and any change not covered by a plan.
What arrives
- The position under test
- Verdict
- The challenges, by angle
- Which challenges survive
- The pre-mortem
- What would have to be true
- Mitigations and tripwires
- Where the position is weakest
What it will not do
It stays adversarial and does not defend the plan. It is a stress test by AI specialists and not a vote of human experts, and the decision stays with you.
It is not regulatory advice and does not predict an FDA decision.
It does not defend the plan. Defenses appear only as the status of an attack.
It does not invent an attack. Each challenge rests on a cited fact or is marked as a gap.
It is not a vote of human experts. Every seat is an AI specialist, and the report says so.
References
- [1] U.S. Food and Drug Administration. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Title known from FDA’s guidance listing; its status and date were not checked on this pass.
- [2] U.S. Food and Drug Administration. Quality Management System Regulation (21 CFR Part 820). Known from FDA’s site; the effective date of the current rule was not checked.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Panel service
Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.
To edit a saved template, open New → Panel → From template, or the library rail on the service form.