21 CFR Part 807 — Establishment Registration and Device Listing

21 CFR Part 807 sets forth the requirements for establishment registration and medical device listing with the FDA. It mandates that manufacturers, importers, and other establishments involved in the production and distribution of medical devices register annually and list their devices, enabling the FDA to maintain an up-to-date inventory of all marketed devices. The part also covers premarket notification (510(k)) submission requirements.

Overview

Background

Part 807 is administered by the FDA and stems from the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. It was established to create a comprehensive registration and listing system that allows the FDA to identify all establishments involved in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices.

Applicability

This regulation applies to owners or operators of establishments that manufacture, prepare, propagate, compound, assemble, or process medical devices intended for commercial distribution in the United States. Foreign manufacturers who export devices to the U.S. must also comply. Initial importers and specification developers are also subject to these requirements.

Core Principles

Annual establishment registration

Device listing and updates

Premarket notification (510(k)) procedures

Foreign establishment registration

Initial importer obligations

Listing of device activities and classifications

Timely updates for changes in device listing

Registration and listing data accuracy