Investigational Device Exemptions

United States · Last verified: 2026-09-08

Number

21 CFR 812

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

IDE 试验用器械豁免：临床研究用器械的显著风险/非显著风险判定、IDE 申请与 FDA 处理、申办者与研究者职责、IRB 审查、记录与报告。

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