The FDA’s 26 GenAI questions. What the public is saying.

Filings through Sep 17, 2026

FDA GenAI public feedbackAll audiences

95 responses so far to the FDA’s GenAI questions.

Over the first 31 days, industry contributed 57 of 95 submissions (60%), more than all other groups combined. Academia / other contributed the fewest, with 6. There are 31 days remaining before comments close on October 19.

View all submissions ↗

One dot per submission. Hover or tap for details.

Filings through Sep 17, 2026

FDA GenAI public feedbackAll audiences

FDA GenAI feedback over time.

The largest daily total was 14 submissions on August 18, the opening day. The next busiest days were September 4 and September 8, with 9 and 8 submissions respectively. With 31 days remaining, the total stands at 95.

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IndustryCliniciansPublic / patientsAcademia / other

One dot per submission. Hover or tap for details.

Filings through Sep 17, 2026

FDA Q19 · Postmarket performance evaluation

FDA GenAI public feedbackAll audiences

The FDA GenAI questions getting the most attention.

Of the FDA’s 26 questions, these three appear most often across 95 public submissions so far. Counts show references, not agreement; each card also highlights leading recommendations or positions in the coded filings.

How should an AI device be monitored after launch, and what sets the cadence?

41 of 95 filings name it

Most mentioned · 3 of 4 · 21 coded

Repeat performance testing on a schedule14

Reassess after changes or safety signals12

Have clinicians review samples of outputs9

A filing can propose more than one.

FDA Q1 · The two-axis risk framework

Does a two-axis framework, AI device activity and the consequence of relying on an incorrect output, capture the dimensions of risk?

34 of 95 filings name it

Positions · 21 coded

Keep it, but add or change elements20

The framework is insufficient1

Keep the framework as proposed0

FDA Q26 · Agentic devices

What extra oversight does an AI that plans and acts in multiple steps need?

32 of 95 filings name it

Most mentioned · 3 of 7 · 22 coded

Limit or test what the agent is allowed to do13

Keep records that let investigators reconstruct actions13

Require human approval for specified consequential actions12

A filing can propose more than one.

IndustryCliniciansPublic / patientsAcademia / other

Explore all 26 questions ↓

Source: FDA public docket · FDA-2026-N-7874 ↗ · Preliminary analysis

Filings through Sep 17, 2026 · Responses: Sep 13 snapshot · Citing a question does not imply agreement.

Themes across the public feedbackAll audiences

Top themes shaping the FDA GenAI discussion.

A synthesis of the top emerging themes across public submissions. These themes connect several FDA questions and will evolve as new submissions are reviewed. Counts show submissions raising each theme, not agreement.

IndustryCliniciansPublic / patientsAcademia / other

Source: FDA public docket · FDA-2026-N-7874 ↗ · Preliminary analysis

Filings through Sep 17, 2026 · Filings may appear in several themes.

FDA Q1 · The two-axis risk framework

FDA GenAI public feedbackAll audiences

Public feedback on all 26 FDA GenAI questions.

Explore each question and the submissions that discuss it.

IndustryCliniciansPublic / patientsAcademia / other

Assessing clinical riskQ1–Q6

Does a two-axis framework, AI device activity and the consequence of relying on an incorrect output, capture the dimensions of risk?

34 of 95 filings name it

FDA Q2 · The spectrum of device activity

How should the continuum from non-directive to action-directing outputs, and the risk that changes along it, be accounted for?

23 of 95 filings name it

FDA Q3 · When an output becomes directive

When clinical information goes straight to the patient, does the risk change, and what safeguards help without underestimating patients?

25 of 95 filings name it

FDA Q4 · Generalist and specialist users

Should it matter whether the clinician using the AI is a generalist or a specialist?

19 of 95 filings name it

FDA Q5 · Multi-turn conversations that migrate

How is risk assessed when a conversation starts with non-directive information and drifts into action-directing?

22 of 95 filings name it

FDA Q6 · Care escalation functions

How should under-escalation be weighed against over-escalation?

27 of 95 filings name it

Demonstrating clinical competenceQ7–Q17

FDA Q7 · The competency-based approach

Is the two-step approach, benchmark the AI, then confirm it in clinical use, the right way to evaluate these devices?

23 of 95 filings name it

FDA Q8 · Mapping the risk grid to evidence

Should an AI device’s position on the risk map help decide how much evidence it must bring before market?

15 of 95 filings name it

FDA Q9 · The benchmarking structure

Do the ten benchmark competencies, from clinical knowledge to generalizability, add up to enough evidence of safety and effectiveness?

31 of 95 filings name it

FDA Q10 · Benchmark contamination and saturation

How can a benchmark score be shown to predict real-world behavior?

26 of 95 filings name it

FDA Q11 · Clinical confirmation without a prospective trial

When can a device be confirmed without a prospective clinical study, and what earns that lighter path?

26 of 95 filings name it

FDA Q12 · Statistically meaningful performance

How do you get statistically meaningful performance numbers when synthetic inputs are mixed with real ones?

21 of 95 filings name it

FDA Q13 · Synthetic data

Where is synthetic data good enough, and where is it not?

22 of 95 filings name it

FDA Q14 · Comparators and acceptance criteria

For open-ended AI outputs, who is the performance comparator: a clinician panel, generalists, specialists, or the human-AI team?

25 of 95 filings name it

FDA Q15 · Performance against usual care

Could the AI be measured against what would have happened without it: unaided judgment, a delayed specialist, or no intervention?

23 of 95 filings name it

FDA Q16 · Independent third parties

What role should independent third parties play?

26 of 95 filings name it

FDA Q17 · Devices with many functions

Does the approach still work for devices built on other model architectures, such as multimodal vision-language models and world models?

12 of 95 filings name it

Monitoring after launchQ18–Q24

FDA Q18 · Trading premarket certainty for postmarket monitoring

Can greater premarket uncertainty about a GenAI device’s benefit-risk profile be accepted through greater reliance on postmarket monitoring?

29 of 95 filings name it

FDA Q19 · Postmarket performance evaluation

How should an AI device be monitored after launch, and what sets the cadence?

41 of 95 filings name it

FDA Q20 · Machine-based supervisory agents

Could AI supervisory agents help carry out postmarket monitoring?

27 of 95 filings name it

FDA Q21 · Clinicians, institutions and societies

What roles should clinicians and institutions play in monitoring, without diluting manufacturer accountability?

27 of 95 filings name it

FDA Q22 · Re-benchmarking after a modification

With the premarket competency assessment as the baseline, which post-deployment changes need re-evaluation, and how much?

29 of 95 filings name it

FDA Q23 · PCCPs for GenAI devices

How can a change-control plan cover changes that cannot be fully specified in advance?

21 of 95 filings name it

FDA Q24 · Third-party foundation model changes

When the foundation model’s developer changes the model, how does the device maker detect it and respond, so safety and effectiveness are not compromised?

30 of 95 filings name it

Source: FDA public docket · FDA-2026-N-7874 ↗ · Preliminary analysis

Filings through Sep 17, 2026 · Responses: Sep 13 snapshot · Citing a question does not imply agreement.

Who’s saying what?

All audiences shown for comparison.

Provisional mapping: industry includes startups, large companies and consultants; practitioners includes clinicians and health systems. Academia is shown separately. Filings are not a representative population survey.

The conditions matter.

How much autonomy is accepted?

Highest accepted autonomy, compared across two consequence levels.

Autonomy →

Two debates worth watching.

Two themes drawn from the FDA’s questions.

FDA GenAI public feedbackAll audiences

The public submissions behind the FDA GenAI discussion.

Browse the filings, contributors and original source documents.

Filings through Sep 17, 2026