Anonymous
Themes it raises
5 of the 21 themes in the docket.
Judging devices the way clinicians are credentialedFDA Q7, Q8
How this fits rules that already existFDA Q8, Q9, Q16, Q25
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
What the rules cost sponsors and the marketNot asked by the FDA
Whether the user can judge the outputFDA Q3, Q4
Machine-assisted draft, pending human review. The original submission is linked below. Read the filing on regulations.gov ↗
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