Brief · Use case · Regulatory
SaMD Authorization Outlook.
LiveOutlookProject whether an AI diabetic retinopathy screening device gets FDA marketing authorization within 18 months, with a likelihood, range and signposts.
SaMD Authorization Outlook is a ready-made use case for Regulatory. It ships under the Outlook template.
For regulatory leads sizing a timeline. You get the projected event, horizon and resolution test, the base rate from comparable authorizations, a central path with a range, scenarios and early signposts. 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
Will an AI-based software as a medical device for diabetic retinopathy screening obtain FDA marketing authorization within 18 months, and how likely is it?
What the outlook examines
FDA publishes the clocks it works to, so the outlook starts from those clocks and adds the time a sponsor controls.
| Part of the outlook | What it asks | Where it looks |
|---|---|---|
| The agency’s own goals | 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. The total-time goal for 510(k)s received in fiscal years 2025 to 2027 is 112 calendar days.1 | The MDUFA performance goals and procedures. |
| The route | Whether a predicate exists decides between a 510(k) and a De Novo request, and the choice changes the clock.2,3 | FDA’s 510(k) and De Novo pages. |
| The reference class | What FDA reports about its performance against its goals, and how many AI-enabled devices it has authorized: more than 1,600 as of September 2026.4,5 | FDA’s performance report and its list of AI-enabled devices. |
What the outlook does
FDA days are not calendar days. The goals count the days a submission is with FDA and not the time it waits for the sponsor. The outlook adds the sponsor’s time to FDA’s time and says what share of the 18 months each might take.1
A base rate from FDA’s own record. FDA reports its performance against its goals each year. The outlook uses the performance report as the reference class for review time, and says that it concerns FDA’s time and not whether a particular submission succeeds.4
The category exists. FDA lists more than 1,600 authorized AI-enabled devices and says the list is not exhaustive. That shows the pathway is in use, not that any one submission will succeed.5
Resolution. The question resolves when FDA records a decision for the device in its 510(k) or De Novo database, within 18 months of the stated start date.2,3
Recommended length
Standard
One path dominates the question. Standard carries the projection, the base rate, the path, the drivers and the signposts in about 1,200 words.
You can pick another length on the form. The other two stay available.
Assumptions the outlook checks
The outlook states the assumptions its likelihood rests on and names the weakest one. Examples for this question:
- A predicate exists, or the sponsor files a De Novo request without losing time.
- The submission is accepted for review without a refusal to accept.
- The evidence the sponsor holds is the evidence FDA will ask for.
Standards, guidance and sources
FDA clocks and records
- MDUFA performance goals and procedures, fiscal years 2023 through 2027.1
- FDA, Premarket Notification 510(k) and De Novo Classification Request pages.2,3
- FDA, Performance Report to Congress on the medical device user fee program, fiscal year 2025.4
- FDA, List of Artificial Intelligence-Enabled Medical Devices.5
The decision practice behind the memo itself is on the template page.
What gets flagged
Any step whose duration is on the sponsor’s side, any dependency on a predicate that has not been confirmed, and any use of FDA’s goals as a prediction for one submission.
What arrives
- The projection
- Starting point and base rate
- What is already in motion
- The most likely path
- Scenarios
- What would change it
- Signposts
- Confidence, and where it is weakest
What it will not do
It does not predict with certainty or recommend an action. The likelihood carries a range, confidence is stated separately, and a Decision Memo uses the outlook as an input.
It does not predict FDA’s decision, only the timing and likelihood on stated assumptions.
It does not predict with certainty. A likelihood is a statement about the evidence, with a range, and the outlook says how sure it is separately.
It does not make a base rate from nothing. Where no reference class exists, the base rate table says so and the likelihood is labeled analyst judgment.
It does not recommend an action. A Decision Memo takes the outlook as an input.
References
- [1] U.S. Food and Drug Administration. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027. Read on 9 October 2026.
- [2] U.S. Food and Drug Administration. Premarket Notification 510(k). Page last updated 22 August 2024.
- [3] U.S. Food and Drug Administration. De Novo Classification Request. Page last updated 30 September 2025.
- [4] U.S. Food and Drug Administration. Performance Report to Congress: Medical Device User Fee Amendments, fiscal year 2025. Opening text read on 9 October 2026; no figures from it are quoted.
- [5] U.S. Food and Drug Administration. List of Artificial Intelligence-Enabled Medical Devices. FDA reports more than 1,600 authorized devices as of September 2026. FDA says the list is not exhaustive.
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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