Medical Devices; Reports of Corrections and Removals

United States · Last verified: 2026-09-08

Number

21 CFR 806

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

器械"纠正与移除"报告：制造商和进口商为降低健康风险而采取的现场纠正或产品移除，须向 FDA 报告并保存记录（与 Part 7 自愿召回配套）。

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