Labeling

United States · Last verified: 2026-09-08

Number

21 CFR 801

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

器械标签总规定：一般标签要求、UDI 标签要求、OTC 器械标签、"充分使用说明"豁免及其他豁免，并对部分特定器械（如助听器、隐形眼镜）设专项标签要求。

Source: U.S. Food and Drug Administration (public domain)