Institutional Review Boards

United States · Last verified: 2026-09-08

Number

21 CFR 56

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

IRB 伦理审查委员会：IRB 的组成、职能与运作、加快审查、记录与报告要求，以及不合规时的行政处理；器械临床试验须经 IRB 审查批准。

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