Medical Device Reporting

United States · Last verified: 2026-09-08

Number

21 CFR 803

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

MDR 医疗器械不良事件报告制度：规定制造商、进口商和使用单位对死亡、严重伤害及故障事件的可报告性判定、报告时限、格式与后续补充报告。

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