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.Research by
The FDA’s 26 GenAI questions.What the public is saying.
Public feedback on the regulation of generative AI-enabled medical devices.
Filings through Sep 16, 2026
FDA GenAI public feedbackAll audiences
95 responses so far to the FDA’s GenAI questions.
Over the first 30 days, industry contributed 57 of 95 submissions (60%), more than all other groups combined. Academia / other contributed the fewest, with 6. There are 32 days remaining before comments close on October 19.
Filings through Sep 16, 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 32 days remaining, the total stands at 95.
All audiences
IndustryCliniciansPublic / patientsAcademia / other
Filings through Sep 16, 2026
FDA GenAI public feedbackAll audiences
The FDA GenAI questions most often cited.
Postmarket monitoring, risk assessment and oversight of AI that plans and acts lead the question counts.
Positions · 21 coded
Keep it, but add or change elements20
The framework is insufficient1
Keep the framework as proposed0
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
Source: FDA public docket · FDA-2026-N-7874 ↗ · Preliminary analysis
Filings through Sep 16, 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 16, 2026 · Filings may appear in several themes.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
Source: FDA public docket · FDA-2026-N-7874 ↗ · Preliminary analysis
Filings through Sep 16, 2026 · Responses: Sep 13 snapshot · Citing a question does not imply agreement.FDA GenAI public feedbackAll audiences
The public submissions behind the FDA GenAI discussion.
Browse the filings, contributors and original source documents.
Filings through Sep 16, 2026
Explore the 26 FDA questions
Counts show coverage among the selected audience, not agreement.