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Robert Lacroix

IndustryConsultantFiled August 20, 2026291 wordsFDA-2026-N-7874-0022

What they argued

RecovryAI’s one-line reading of the filing.

'Bar has to be higher for AI that replaces doctors' decisions'; demands off switch and doctor-level liability; nothing on evidence or change control.

Themes it raises

1 of the 21 themes in the docket, each with the passage we counted, verbatim.
Who is accountable when something goes wrongFDA Q21
“A ChatGPT style medical disclaimer caveat is not acceptable; the device must own their decisions and be held accountable for them the same as a doctor is with their decisions.”

Across the five cross-cutting questions

RecovryAI’s reading of the whole filing. Silence is never counted as opposition.
Patient-facing autonomyShould FDA permit patient-facing AI to act with meaningful autonomy within a defined scope?
Opposes
Proportionate evidenceShould evidence requirements scale with clinical risk rather than a uniform high bar?
No position stated
Postmarket relianceCan strong postmarket monitoring justify accepting more premarket uncertainty?
No position stated
Competency evaluationCan a device be evaluated on competency benchmarks and clinical confirmation against clinicians?
No position stated
Change controlCan devices on third-party foundation models be maintained under pre-specified change control?
No position stated
Autonomy acceptedThe highest level this filing accepts
Low-consequence work: Not stated
High-consequence work: Not stated
Read and coded by RecovryAI readers, September 12, 2026. The source text and highlighted passages appear below. Read the filing on regulations.gov ↗

The comment as filed

Comment submitted on regulations.gov. Passages we counted are highlighted.

RE: Feedback for Considerations for the Regulation of Generative AI-Enabled Medical Devices; Reference Docket ID: FDA-2026-N-7874

Thank you for this opportunity.

The key in developing actionable regulation of generative AI-enabled devices is a legal consequence structure for failures to both the device and specifically the owners/developers/sellers of the device.

This is Especially important when considering Agentic-AI that functions autonomously.

In a nutshell this regulation must work to ensure accuracy in all medical decisions from a device with no consciousness that never went to medical school, and cannot lose their medical license.

A ChatGPT style medical disclaimer caveat is not acceptable; the device must own their decisions and be held accountable for them the same as a doctor is with their decisions.

The regulation requires two enforceable guiding principles:
1.An Off Switch - as in the switch that turned off “Commander Data in Star Trek the Next Generation”.
2.Doctor Level Accountability – to the owners/developers/sellers of the device in that there are known legal guidelines if their device fails for patients to ensure that they are “on the hook” with both personal liability, and the loss of medical licenses when appropriate.

These principles allow the consequences of failure to be known “up-front” so that the development of the device includes them. Twenty plus years in the industry across the development and improvement of hundreds medical devices has taught me that it is always more expensive to fix issues after the FDA gets involved.

At the end of the day, the bar has to be higher for the people pursuing AI that replaces doctor’s decisions. Or, they can go to medical school and get licensed to practice medicine so that they too can make medical decisions for patients directly.

Respectfully,

Robert Lacroix
Executive Director
LTC - Healthcare, Diagnostics & Life Science

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