Postmarket Surveillance

United States · Last verified: 2026-09-08

Number

21 CFR 822

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

上市后监督（FD&C 法 522 条）：FDA 下达上市后监督命令的情形、企业提交监督计划、FDA 审查与批准、执行责任、豁免与记录报告。

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