21 CFR Part 801 — Labeling

21 CFR Part 801 establishes the general labeling requirements for medical devices marketed in the United States. It specifies the information that must appear on device labels and labeling, including intended use, adequate directions for use, and warnings necessary for safe and effective use.

Overview

Background

Part 801 is maintained by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. It codifies the labeling provisions that apply to all medical devices, ensuring that labeling is truthful, non-misleading, and provides the information healthcare professionals and users need.

Applicability

This regulation applies to all manufacturers, repackagers, relabelers, and distributors of medical devices marketed in the United States. It covers both prescription and over-the-counter devices and defines requirements for labels, labeling, user instructions, and promotional materials.

Core Principles

Adequate directions for use

Truthful and non-misleading labeling

Intended use identification

Required cautionary statements

Prescription device labeling requirements

Prominence and conspicuousness of required information

Name and place of business on labels

Exemptions from adequate directions for use