Anonymous
Themes it raises
11 of the 21 themes in the docket.
What makes a function high riskFDA Q1, Q2, Q5
Harm from an output that was not wrongFDA Q1, Q2
Trading premarket certainty for postmarket monitoringFDA Q18
Watching the device after it shipsFDA Q19, Q20
What the rules cost sponsors and the marketNot asked by the FDA
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
How this fits rules that already existFDA Q8, Q9, Q16, Q25
Whether benchmark results prove anythingFDA Q9, Q10, Q16
Proving the device works in real careFDA Q11, Q12, Q13, Q14, Q15
Privacy and protection of patient dataNot asked by the FDA
Judging devices the way clinicians are credentialedFDA Q7, Q8
FDA questions it names
Questions this filing names by number.
Q18 · Trading premarket certainty for postmarket monitoringQ24 · Third-party foundation model changesQ25 · Foundation Model Master Files
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