Ezequiel Méndez Romero
Themes it raises
3 of the 21 themes in the docket.
Records that let investigators reconstruct an eventFDA Q19, Q21, Q24, Q26
Watching the device after it shipsFDA Q19, Q20
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 ↗
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 ↗