Brief · Use case · Regulatory
Device Pathway Comparison.
LiveComparisonCompare 510(k), De Novo and PMA for a new AI software device on eligibility, evidence, review goal, fee and claim limits.
Device Pathway Comparison is a ready-made use case for Regulatory. It ships under the Comparison template.
For regulatory leads choosing how to approach the FDA. You get the pathways and criteria stated first, one sourced table, where the pathways differ most and where figures are not like-for-like. Cells are cited to FDA documents 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
How do the 510(k), De Novo and premarket approval pathways compare for a new AI-enabled software medical device on eligibility, evidence expected, review goal, user fee and typical limits on the claim?
What is compared
The comparison uses FDA’s own program pages, so each cell is FDA’s statement and carries its date.
| Pathway | What it asks for | Where its cells come from |
|---|---|---|
| 510(k) | A device shown to be substantially equivalent to a legally marketed predicate: the same intended use, and the same technology or different technology that raises no new questions of safety and effectiveness.1,2,4 | FDA’s 510(k) page and its advice on predicates. Standard fee for FY 2027: $28,653. |
| De Novo | A request to classify a novel device with no legally marketed predicate, under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act. A granted device can serve as a predicate for later 510(k)s.3,4 | FDA’s De Novo page. Standard fee for FY 2027: $191,020. |
| Premarket approval | FDA’s most stringent review, for high-risk Class III devices. The standard is sufficient valid scientific evidence that the device is safe and effective for its intended use.5,4 | FDA’s PMA page. Standard fee for FY 2027: $636,732. |
What the comparison does
Eligibility as FDA states it. A 510(k) turns on a predicate, a De Novo request on the absence of one, and a PMA on the device’s risk class. The comparison puts each condition in its own cell and says what happens to a device that falls between them.1,3,5
Fees from FDA’s schedule, with their dates. FDA’s fee schedule for fiscal year 2027, which runs from 1 October 2026 to 30 September 2027, gives standard and small business fees for each route. The comparison cites the schedule and says the figures change every year.4
Review goals and limits on the claim. Review goals are FDA targets, not guarantees, and the comparison says where the figure it cites comes from. Limits on the claim are read from the program pages and from cleared labeling, and a limit with no source is a gap.1,3,5
AI-enabled software. The comparison notes whether FDA’s January 2025 draft guidance on AI-enabled device software functions affects what each pathway expects, and says plainly that it is a draft.6
Recommended length
Standard
Three pathways on five criteria fit a single table, with where they differ most. Standard carries that in about 1,200 words.
You can pick another length on the form. The other two stay available.
Assumptions the comparison checks
The comparison states the assumptions that make the cells comparable and says where they fail. Examples for this subject:
- The device is software with a medical purpose and is regulated as a device.
- The fee year in the comparison matches the year of submission.
- FDA’s program pages cited are current.
Standards, guidance and sources
FDA pathways
Fees and AI guidance
The decision practice behind the memo itself is on the template page.
What gets flagged
Any review goal or timeline that is not tied to a current FDA source, the pathway most likely to fit a device with an uncertain predicate, and where the fee year differs from the submission year.
What arrives
- What is compared, and on what criteria
- The comparison
- Where the difference matters
- Where they do not differ
- Caveats on comparability
What it will not do
It does not recommend an item. A comparison shows how the items differ and where they do not; if you need a recommendation, run a Decision Memo on the same items.
It does not determine your device’s classification or eligibility. FDA does.
It does not recommend an item. A comparison shows differences; a Decision Memo recommends.
It does not handle more than five items. Beyond five, the table stops being readable and a Landscape or a Scan is the better template.
It does not invent a cell. A cell without a source is a gap, and the caveats say how many there are.
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. Premarket Approval (PMA). Page last updated 16 May 2019.
- [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.
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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