Saurabh Sharma
Themes it raises
3 of the 21 themes in the docket.
Watching the device after it shipsFDA Q19, Q20
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
How this fits rules that already existFDA Q8, Q9, Q16, Q25
FDA questions it names
Questions this filing names by number.
Q24 · 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?
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: 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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