Product Jurisdiction

United States · Last verified: 2026-09-08

Number

21 CFR 3

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

产品管辖权：组合产品"主要作用方式"（PMOA）的判定原则，以及通过指定申请（RFD）确定由 CDRH、CDER 还是 CBER 主审的程序。

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