General Enforcement Regulations

United States · Last verified: 2026-09-08

Number

21 CFR 1

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

FDA 通用执法规定，其中与器械相关的包括一般标签要求、电子进口申报、进出口条款（如出口证书与出口产品要求）等；食品专属分部不适用于器械。

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