Milan Toma
Themes it raises
8 of the 21 themes in the docket.
Whether benchmark results prove anythingFDA Q9, Q10, Q16
Trading premarket certainty for postmarket monitoringFDA Q18
Watching the device after it shipsFDA Q19, Q20
Judging devices the way clinicians are credentialedFDA Q7, Q8
Equity, access and under-resourced settingsFDA Q3, Q13, Q21
Controlling a device that keeps changingFDA Q22, Q23, Q24, Q25
How this fits rules that already existFDA Q8, Q9, Q16, Q25
What counts as a reportable eventFDA Q19, Q20
Machine-assisted draft, pending human review. The original submission is linked below. Read the filing on regulations.gov ↗
This filing was submitted by a member of the public. We publish our analysis here and link to the submission rather than reproducing it, and this page is not indexed by search engines. Read the full submission on regulations.gov ↗