Regulation of Combination Products

United States · Last verified: 2026-09-08

Number

21 CFR 4

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

组合产品监管：Subpart A 规定组合产品 cGMP，允许以器械 QMS 或药品 cGMP 为基础加上对方体系的特定条款实现简化合规；Subpart B 规定组合产品的上市后安全性报告。

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