Qiong Liu
Themes it raises
5 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
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
Harm from an output that was not wrongFDA Q1, Q2
FDA questions it names
Questions this filing names by number.
Q1 · The two-axis risk frameworkQ5 · Multi-turn conversations that migrateQ6 · Care escalation functionsQ7 · The competency-based approachQ9 · The benchmarking structureQ10 · Benchmark contamination and saturationQ16 · Independent third partiesQ19 · Postmarket performance evaluationQ22 · Re-benchmarking after a modificationQ24 · Third-party foundation model changes
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 with conditions
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 with conditions
Change controlCan devices on third-party foundation models be maintained under pre-specified change control?
Supports with conditions
Autonomy acceptedThe highest level this filing accepts
Low-consequence work: Not stated
High-consequence work: Not stated
High-consequence work: Not stated
Machine-assisted draft, pending human review. The original submission is linked below. Read the filing on regulations.gov ↗
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