Anonymous
Themes it raises
12 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
Proving the device works in real careFDA Q11, Q12, Q13, Q14, Q15
Trading premarket certainty for postmarket monitoringFDA Q18
Watching the device after it shipsFDA Q19, Q20
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
Records that let investigators reconstruct an eventFDA Q19, Q21, Q24, Q26
What counts as a reportable eventFDA Q19, Q20
How this fits rules that already existFDA Q8, Q9, Q16, Q25
Whether human oversight is real oversightFDA Q3, Q4, Q14, Q20, Q21, Q26
Who is accountable when something goes wrongFDA Q21
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