Enforcement Policy

United States · Last verified: 2026-09-08

Number

21 CFR 7

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

执法政策：企业自愿召回的定义、召回分级（Class I/II/III）、健康危害评估、召回策略与进展报告、公开召回信息，以及刑事违法条款。

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