Anonymous
What they argued
RecovryAI’s one-line reading of the filing.
Supports two-axis calibration, competency model; flexible PCCPs 'without burdensome supplemental clearances'; MAFs; streamlined HCP-supervised pathways.
Themes it raises
6 of the 21 themes in the docket.
What makes a function high riskFDA Q1, Q2, Q5
Judging devices the way clinicians are credentialedFDA Q7, Q8
Whether benchmark results prove anythingFDA Q9, Q10, Q16
Watching the device after it shipsFDA Q19, Q20
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
What the rules cost sponsors and the marketNot asked by the FDA
FDA questions it names
Questions this filing names by number.
Q1 · The two-axis risk frameworkQ7 · The competency-based approachQ18 · Trading premarket certainty for postmarket monitoringQ25 · Foundation Model Master Files
Coded positions
Where a position was recorded question by question.
Q25Would voluntary Foundation Model Master Files be practical, and useful in premarket review?
Use voluntary foundation-model master files
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?
No position stated
Proportionate evidenceShould evidence requirements scale with clinical risk rather than a uniform high bar?
Supports
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?
Supports
Change controlCan devices on third-party foundation models be maintained under pre-specified change control?
Supports
Autonomy acceptedThe highest level this filing accepts
Low-consequence work: Not stated
High-consequence work: Not stated
High-consequence work: Not stated
Read and coded by RecovryAI readers, September 12, 2026. The original submission is linked below. Read the filing on regulations.gov ↗
This filing was submitted by a member of the public. We publish our analysis here and link to the submission rather than reproducing it, and this page is not indexed by search engines. Read the full submission on regulations.gov ↗