Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

United States · Last verified: 2026-09-08

Number

21 CFR 807

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

器械场地注册与产品列名：境内与境外企业的注册/列名程序和豁免；Subpart E 为 510(k) 上市前通告程序，含实质等同性判定与内容要求。

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