Sergey Morev
Themes it raises
6 of the 21 themes in the docket.
Devices that plan and take actionsFDA Q26
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
Security, dependencies and what happens when they failFDA Q1, Q9, Q24
Whether benchmark results prove anythingFDA Q9, Q10, Q16
Proving the device works in real careFDA Q11, Q12, Q13, Q14, Q15
Watching the device after it shipsFDA Q19, Q20
FDA questions it names
Questions this filing names by number.
Q1 · The two-axis risk frameworkQ9 · The benchmarking structureQ10 · Benchmark contamination and saturationQ18 · Trading premarket certainty for postmarket monitoringQ19 · Postmarket performance evaluationQ22 · Re-benchmarking after a modificationQ23 · PCCPs for GenAI devicesQ24 · Third-party foundation model changesQ26 · Agentic devices
Machine-assisted draft, pending human review. The original submission is linked below. Read the filing on regulations.gov ↗
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