Xiangyu Guo (Independent Researcher)
Themes it raises
7 of the 21 themes in the docket.
Watching the device after it shipsFDA Q19, Q20
Who is accountable when something goes wrongFDA Q21
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
Devices that plan and take actionsFDA Q26
Whether human oversight is real oversightFDA Q3, Q4, Q14, Q20, Q21, Q26
Records that let investigators reconstruct an eventFDA Q19, Q21, Q24, Q26
How this fits rules that already existFDA Q8, Q9, Q16, Q25
FDA questions it names
Questions this filing names by number.
Q19 · Postmarket performance evaluationQ21 · Clinicians, institutions and societiesQ22 · Re-benchmarking after a modificationQ26 · Agentic devices
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?
Supports with conditions
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?
Supports with conditions
Autonomy acceptedThe highest level this filing accepts
Low-consequence work: Informs
High-consequence work: Directs
High-consequence work: Directs
Machine-assisted draft, pending human review. The original submission is linked below. Read the filing on regulations.gov ↗
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