Brief · Use case · Regulatory

Regulatory Pathway Decision.

LiveDecision Memo

Choose between a 510(k), a De Novo request and waiting for more evidence, with each route scored on cost, time, evidence burden and risk, and the one fact that would change the answer.

DeciderChief regulatory officer

Needed by30 April 2027

Routes scored3

Criteria5

ExpertVP Global Regulatory Strategy

LengthComprehensive

Regulatory Pathway Decision is a ready-made use case for Regulatory. It ships under the Decision Memo template.

For regulatory and product leads facing a pathway choice that is expensive to reverse. The memo states the decision, names who decides, scores the routes side by side, charts the ranking and tests the recommendation against a pre-mortem. Fees and review goals are cited to their sources 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

Which US premarket pathway for an AI-based software as a medical device that flags diabetic retinopathy from retinal images: a 510(k) against a predicate, a De Novo request, or delaying to generate more evidence?

The three routes on the table

The memo scores each route on the same five criteria, so the choice rests on your constraints and not on habit.

Route	What it asks of you	It fits when	FDA user fee, fiscal year 2027
510(k) against a predicate	Show that the device is substantially equivalent to a legally marketed predicate. FDA must issue an order finding equivalence before you can market.^{1U.S. Food and Drug Administration. Premarket Notification 510(k). Page last updated 22 August 2024.,2U.S. Food and Drug Administration. How to Find and Effectively Use Predicate Devices. Content current as of 4 September 2018.}	A legally marketed device with the same intended use exists, and your technology is the same or raises no new questions of safety and effectiveness.	$28,653 standard; $7,163 small business
De Novo request	Ask FDA to classify a novel device under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act. If granted, the device can serve as a predicate for later 510(k) submissions.^{3U.S. Food and Drug Administration. De Novo Classification Request. Page last updated 30 September 2025.}	The device is novel and there is no legally marketed predicate to compare it with.	$191,020 standard; $47,755 small business
Delay to generate more evidence	Hold the submission, generate the evidence, then choose a route. Nothing is filed, so no FDA fee is paid.	The evidence you hold would not carry either route, or the predicate question is still open. The memo prices the delay in time, runway and competitive position.	None until you file

Fiscal year 2027 runs from 1 October 2026 to 30 September 2027. FDA fees change each year, so check the schedule for the year you file.^{4U.S. Food and Drug Administration. Medical Device User Fee Amendments (MDUFA): Fees. Fiscal year 2027 amounts.}

What the memo does with them

A predicate check, not a guess. The memo says where it searched and what it found. FDA advises choosing the primary predicate closest to your device in indications for use and technological characteristics, and searching its 510(k) database by product code. The memo also looks at FDA’s list of authorized AI-enabled devices. When no defensible predicate turns up, it says so, and what that does to the 510(k) option.^{2U.S. Food and Drug Administration. How to Find and Effectively Use Predicate Devices. Content current as of 4 September 2018.,8U.S. Food and Drug Administration. List of Artificial Intelligence-Enabled Medical Devices. Updated periodically; FDA reports more than 1,600 authorized devices as of September 2026.}

Five criteria, scored the same way for all three routes. Cost, time to decision, evidence burden, regulatory risk and commercial risk. Fees are cited to FDA’s schedule and review times to FDA’s report on its review goals. The scores themselves are analyst judgment, and the memo labels them that way.^{4U.S. Food and Drug Administration. Medical Device User Fee Amendments (MDUFA): Fees. Fiscal year 2027 amounts.,5U.S. Food and Drug Administration. Performance Report to Congress: Medical Device User Fee Amendments, fiscal year 2025.}

The software checks. For an AI-enabled function the memo reads FDA’s January 2025 draft guidance on lifecycle management and marketing submissions, and its final guidance on predetermined change control plans, which let a manufacturer specify planned model changes in the submission. It says plainly that the lifecycle guidance is still a draft.^{6U.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.,7U.S. Food and Drug Administration. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Final guidance, December 2024.}

The software’s risk, in IMDRF terms. The memo describes the software’s risk using the IMDRF framework for software as a medical device, so the regulatory case and the risk case use the same vocabulary.^{9International Medical Device Regulators Forum. Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. IMDRF/SaMD WG/N12, 2014.}

How it could fail. The pre-mortem probes the failures this decision tends to invite: the predicate is challenged late, the evidence you hold is not what FDA asks for, the AI model changes before clearance, or the submission window closes while you generate evidence. Each gets an early warning and an owner.

Recommended length

Comprehensive

The decision is expensive to reverse, and the predicate and fee assumptions carry the answer. Comprehensive adds the table that tests each assumption.

You can pick another length on the form. The other two stay available.

Assumptions the memo tests

A Comprehensive memo lists the assumptions that carry the answer, each with a test and a date. A Standard memo carries the main ones in its section on what would change the answer. Examples for this decision:

A legally marketed device with the same intended use exists.
The performance evidence you hold is the evidence FDA will ask for.
The review timeline fits the submission window you set for 30 April 2027.
The commercial case holds if a route takes longer than planned.

Standards, guidance and sources

FDA pathways

The 510(k) program: substantial equivalence to a legally marketed predicate, and the content of a submission.^{1U.S. Food and Drug Administration. Premarket Notification 510(k). Page last updated 22 August 2024.}
FDA’s advice on finding and using predicate devices.^{2U.S. Food and Drug Administration. How to Find and Effectively Use Predicate Devices. Content current as of 4 September 2018.}
The De Novo classification request, under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.^{3U.S. Food and Drug Administration. De Novo Classification Request. Page last updated 30 September 2025.}

Fees and timing

FDA’s published user fee schedule for fiscal year 2027.^{4U.S. Food and Drug Administration. Medical Device User Fee Amendments (MDUFA): Fees. Fiscal year 2027 amounts.}
FDA’s performance report to Congress on its medical device review goals, fiscal year 2025.^{5U.S. Food and Drug Administration. Performance Report to Congress: Medical Device User Fee Amendments, fiscal year 2025.}

AI and software guidance

Draft guidance on AI-enabled device software functions: lifecycle management and marketing submission recommendations, January 2025. It is a draft and does not yet bind FDA or sponsors.^{6U.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.}
Final guidance on marketing submission recommendations for a predetermined change control plan for AI-enabled device software functions.^{7U.S. Food and Drug Administration. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Final guidance, December 2024.}
FDA’s list of authorized AI-enabled medical devices, which FDA says is not exhaustive.^{8U.S. Food and Drug Administration. List of Artificial Intelligence-Enabled Medical Devices. Updated periodically; FDA reports more than 1,600 authorized devices as of September 2026.}

Risk framework

IMDRF categorization of software as a medical device by the significance of the information it provides and the healthcare situation.^{9International Medical Device Regulators Forum. Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. IMDRF/SaMD WG/N12, 2014.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Whether a defensible predicate exists, every fee and review time that is not tied to a current FDA source, and the one fact that would move the recommendation.

What arrives

Decision requested
Recommendation
Context and framing
Options considered
Why this option wins
What must be true
What would change the answer
Risks and the pre-mortem
Path and what we do not know

What it will not do

It does not tell you whether your device qualifies for a route, and it does not predict what FDA will decide. FDA makes that determination. The memo sets out the evidence for and against each route.

It does not replace regulatory counsel or a conversation with FDA.

It does not make the decision. The named decider does.

Scores and weights are analyst judgment from an AI specialist, not measurements. They show how the options compare on the criteria you chose; change the weights and the ranking can change.

It is one specialist’s answer. When you need several specialists to disagree in the open, run a Panel.

Facts the specialist could not source appear as gaps. Regulatory fees, review goals, reference prices and probabilities are cited to their sources or left open. Check any figure you will act on against its primary source.

References

[1] U.S. Food and Drug Administration. Premarket Notification 510(k). Page last updated 22 August 2024.
[2] U.S. Food and Drug Administration. How to Find and Effectively Use Predicate Devices. Content current as of 4 September 2018.
[3] U.S. Food and Drug Administration. De Novo Classification Request. Page last updated 30 September 2025.
[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. Performance Report to Congress: Medical Device User Fee Amendments, fiscal year 2025.
[6] 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.
[7] U.S. Food and Drug Administration. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Final guidance, December 2024. Summarized from FDA’s announcement and webinar pages; read the guidance for its content requirements.
[8] U.S. Food and Drug Administration. List of Artificial Intelligence-Enabled Medical Devices. Updated periodically; FDA reports more than 1,600 authorized devices as of September 2026. FDA says the list is not exhaustive.
[9] International Medical Device Regulators Forum. Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. IMDRF/SaMD WG/N12, 2014. IMDRF has said it intends to revise this document.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

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