FDA Title 21 Sex and Gender Terminology
Current understanding
To be populated as evidence accumulates.
Evidence log
- 2026-08-03 — Modification of Certain Terminology in Title 21; Reopening of the Comment Period: FDA reopened the comment period on the proposed rule to remove or replace ‘gender’ with ‘sex’ throughout Title 21 CFR to implement EO 14168, giving stakeholders additional time to submit input before finalization. (novelty: 2)
Open questions
Related
Contributing findings
Modification of Certain Terminology in Title 21; Reopening of the Comment Period
03-aug-2026
novelty 2
per-area 2
introduces