Jackson Richard
Themes it raises
3 of the 21 themes in the docket.
Whether the user can judge the outputFDA Q3, Q4
What makes a function high riskFDA Q1, Q2, Q5
Judging devices the way clinicians are credentialedFDA Q7, Q8
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 ↗