Anonymous
Themes it raises
4 of the 21 themes in the docket.
What makes a function high riskFDA Q1, Q2, Q5
Security, dependencies and what happens when they failFDA Q1, Q9, Q24
How this fits rules that already existFDA Q8, Q9, Q16, Q25
What the rules cost sponsors and the marketNot asked by the FDA
FDA questions it names
Questions this filing names by number.
Q1 · The two-axis risk frameworkQ2 · The spectrum of device activityQ3 · When an output becomes directiveQ4 · Generalist and specialist usersQ5 · Multi-turn conversations that migrateQ6 · Care escalation functions
Machine-assisted draft, pending human review. The original submission is linked below. Read the filing on regulations.gov ↗
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