Medical Device Registration and Listing: Complete FDA Guide

Overview of Device Registration and Listing

FDA medical device establishment registration and device listing are two distinct but related requirements under 21 CFR Part 807. Establishment registration tells FDA who is making devices and where, while device listing tells FDA what devices are being made. Both are legally required before devices can be commercially distributed in the United States.

These requirements apply to the full spectrum of medical devices — from Class I bandages and tongue depressors to Class III implantable cardiac devices. The registration and listing process is managed through FDA's FURLS system, specifically the Device Registration and Listing Module (DRLM).

For official instructions, see FDA's Device Registration and Listing page.

Who Must Register

The following entities must register their establishments with FDA:

• Manufacturers: Entities that make finished devices or components
• Contract manufacturers: Entities that manufacture devices on behalf of another company (specification developers)
• Repackers and relabelers: Entities that repackage or relabel devices
• Specification developers: Entities that initiate specifications for devices manufactured by contract manufacturers
• Initial importers: The first US entity that imports a device into the United States
• Foreign manufacturers: Non-US entities that manufacture devices exported to the US

Who Is Exempt

• Licensed practitioners who manufacture devices solely for use in their practice
• Entities that exclusively manufacture devices for export and not for US distribution
• Entities that distribute but do not manufacture, repack, relabel, or import devices
• Component manufacturers whose components are not finished devices

Understanding Device Classification

Before registering and listing your devices, you must understand how FDA classifies medical devices. Classification determines the regulatory requirements that apply to your device beyond basic registration and listing.

You can find the classification of your device using FDA's Product Classification Database or Assurentry's product code lookup tool. Each device classification includes a product code, regulation number, and submission type.

The FURLS/DRLM Registration Process

Medical device establishment registration is completed electronically through FDA's Unified Registration and Listing System (FURLS), specifically the Device Registration and Listing Module (DRLM). Here are the steps:

Step 1: Create an FDA Account

Visit FDA Industry Systems and create an account. You will need to provide your name, email, and organization details.

Step 2: Access DRLM

Log into FURLS and navigate to the Device Registration and Listing Module. Select "Establishment Registration" to begin a new registration.

Step 3: Enter Establishment Information

• Official establishment name and physical address
• Owner/operator name and contact information
• Establishment type (manufacturer, contract manufacturer, repacker, etc.)
• US Agent information (required for foreign establishments)

Step 4: Pay the Annual Registration Fee

Unlike food facility registration, medical device establishment registration requires an annual fee. For FY 2026, the annual establishment registration fee is published by FDA in the Federal Register. Payment must be made through FDA's user fee payment system before registration can be completed.

Step 5: Submit and Save Your Registration Number

After submission and fee payment, FDA assigns an FDA Establishment Identifier (FEI) number and an Owner/Operator number. Save these — you will need them for device listing, 510(k) submissions, and annual renewal.

Device Listing Requirements

After registering your establishment, you must list every device you manufacture, repack, relabel, or import through DRLM. Device listing requires the following information for each device:

• Proprietary name: The brand or trade name of the device
• Common/usual name: The generic descriptor
• FDA product code: The three-letter code from FDA's classification database
• Device class: Class I, II, or III
• Premarket submission number: 510(k), PMA, De Novo, or exempt
• Manufacturing establishments: All establishments involved in the manufacture of the device

Listing Updates

Device listings must be updated when you add new devices, discontinue devices, or change any listing information. FDA also requires that listings be reviewed and confirmed during the annual registration renewal period. For more on premarket submissions, see our 510(k) Guide.

Annual Registration Renewal and Fees

Medical device establishment registrations must be renewed annually between October 1 and December 31. The annual registration fee must also be paid during this period.

Renewal Steps

• Log into FURLS/DRLM during the renewal window
• Review and update all establishment and device listing information
• Pay the annual registration fee through FDA's payment system
• Submit the renewal

Consequences of Non-Renewal

• Expired registrations are published on FDA's website, visible to customers and partners
• Foreign establishments with expired registrations may face import refusal
• Domestic establishments face potential enforcement action, including warning letters
• Distributors and hospitals may require current registration as a procurement condition