Anonymous
Themes it raises
5 of the 21 themes in the docket.
Whether human oversight is real oversightFDA Q3, Q4, Q14, Q20, Q21, Q26
Whether the user can judge the outputFDA Q3, Q4
Devices that plan and take actionsFDA Q26
Watching the device after it shipsFDA Q19, Q20
Who is accountable when something goes wrongFDA Q21
Machine-assisted draft, pending human review. The original submission is linked below. Read the filing on regulations.gov ↗
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