FDA Proposes Swapping 'Gender' for 'Sex' in Drug and Device Rules
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Table of Contents
The Food and Drug Administration has published a proposed rule that would replace the word “gender” with “sex” throughout roughly two dozen of its regulations. The changes cover rules for drug and medical device labeling, clinical trial reporting, infant formula standards, and the composition of ethics review boards. The agency also plans to make minor editorial tweaks to improve readability.
Why it matters: This is an administrative update that aligns FDA regulations with a presidential directive. It does not change safety standards, approval processes, or compliance requirements for manufacturers. The practical effect is limited to the specific words used in FDA rulebooks and official guidance documents.
Who it affects
- FDA staff and contractors who draft, edit, or enforce regulations
This is a proposed rule from the FDA published in the Federal Register; it is not yet in effect and may change based on public comments.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document