FDA Establishment Registration & Device Listing: Complete Compliance Guide

FDA Establishment Registration and Device Listing: Two Distinct Requirements You Must Get Right

FDA establishment registration and device listing are separate but connected obligations under 21 CFR Part 807. Registration identifies your facility to the FDA. Listing identifies your specific products. Both use the FDA Unified Registration and Listing System (FURLS) through the Device Registration and Listing Module (DRLM), and both carry real enforcement consequences for non-compliance — including warning letters, import detention, and misbranding determinations.

In July 2025, the FDA issued a warning letter to O3UV, LLC for failing to complete its annual establishment registration and device listing for FY 2025. The agency confirmed the company manufactured autohemotherapy and EBOO devices and found the devices were misbranded under section 502(o) of the FD&C Act because they were manufactured in an unregistered establishment. This is not a theoretical risk — it happens regularly.

For FY 2026 (October 1, 2025 through September 30, 2026), the annual establishment registration fee is $11,423 — a 23.1% increase from FY 2025. This guide covers everything: who must register, how to register, device listing requirements, the payment process, annual renewal deadlines, small business waivers, and the mistakes that trigger enforcement.

What Is Establishment Registration

Legal Basis

Establishment registration is required under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implemented through 21 CFR Part 807, Subpart B. Registration provides the FDA with the location of medical device establishments and the devices manufactured at those locations. The FDA uses this information to prepare for and respond to public health emergencies, plan inspections, and track the device supply chain.

Registration does not denote FDA clearance or approval of an establishment or its products. It is a separate compliance requirement from premarket submissions (510(k), PMA, De Novo).

Who Must Register

Registration is role-specific: each organization involved in manufacturing, specification development, sterilization, repackaging, or initial importation must register independently based on the activities it performs. A single company with multiple facilities must register each facility separately and pay the annual fee for each.

Foreign Establishments: US Agent Requirement

Foreign establishments must designate a US Agent as part of the registration process. The US Agent must live or maintain a place of business in the United States and acts as the FDA's point of contact for communications. The US Agent does not have authority to act on behalf of the establishment for registration or listing purposes but must be available to assist the FDA in scheduling inspections and facilitating communications.

What Is Device Listing

Device listing identifies each specific device an establishment places into US commercial distribution. While registration answers "who are you," listing answers "what do you make."

Required Listing Information

Each listed device must include:

• Proprietary name(s) used in US commercial distribution
• Classification regulation number (e.g., 21 CFR 880.2920)
• Product code (e.g., KGI)
• Premarket submission number, if applicable (510(k), De Novo, PMA, PDP, or HDE number)
• Activities performed by the establishment for each device (manufacture, sterilize, package, etc.)

Intended use and indications are not required fields for listing, and manufacturing site details belong in registration, not the device listing.

When Listing Is Required

A device that requires marketing authorization must wait until clearance or approval is received before listing. A device may not be promoted as "FDA approved" simply because it has been listed.

The FURLS/DRLM System

System Architecture

All registration and listing is submitted electronically through the FDA Unified Registration and Listing System (FURLS), specifically the Device Registration and Listing Module (DRLM), unless a waiver from electronic submission has been granted.

The FURLS account ID and password are separate from the DFUF payment website credentials. A trusted manager with authority to designate sub-accounts should create the FURLS account.

Account Setup for New Establishments

1. Access the FURLS portal through the CDRH website
2. Create a new FURLS account with an account ID and password
3. Designate authorized users with appropriate access levels
4. Only create a new account if your company does not already have one — duplicate accounts cause compliance problems

Step-by-Step Registration and Listing Process

Step 1: Determine Your Requirements

• Classify your device and identify the correct product code
• Determine if premarket submission is required
• Confirm whether your establishment type requires registration, listing, or both
• Foreign companies: appoint a US Agent

Step 2: Pay the Annual Registration Fee

Critical timing: Do not pay the FY fee before October 1 for annual renewal. Early payments apply to the previous fiscal year and cannot be used for the current renewal cycle. Each registered facility requires its own separate PCN.

Step 3: Register the Establishment in FURLS/DRLM

1. Log into FURLS with your account ID and password
2. Navigate to the Device Registration and Listing Module (DRLM)
3. Select "Register a New Facility" (initial) or "Annual Registration" (renewal)
4. Enter establishment information (name, address, ownership, activities)
5. Enter the PIN and PCN from your fee payment
6. Submit registration
7. Print the confirmation screen with your registration number and expiration date

Step 4: List Devices

1. From the DRLM main menu, select device listing
2. Enter each device with its proprietary name, product code, and classification
3. Include premarket submission number (510(k), PMA, etc.) if applicable
4. Specify activities performed on each device
5. Submit listing
6. Review and verify all information

Registration is not considered complete until the PIN and PCN have been applied to a registration in the FURLS/DRLM database.

FY 2026 Fee Schedule and Small Business Relief

Current Fees (FY 2026: October 1, 2025 – September 30, 2026)

The annual establishment registration fee has no small business discount. However, for FY 2026, the FDA may grant a waiver of the registration fee (excluding initial registration) to small businesses that meet all three criteria:

1. Gross receipts and sales of $1 million or less (including affiliates)
2. Demonstration of financial hardship (e.g., active bankruptcy)
3. Proof of prior year's payment of the registration fee

This waiver must be requested through the Small Business Determination (SBD) Program and is granted at the FDA's discretion.

Fee Trends

The 23.1% increase for FY 2026 reflects the MDUFA V revenue adjustment. Unlike other FDA fees, the registration fee is a flat rate with no proration and no small business reduction.

Annual Renewal: October 1 – December 31

Renewal Process

Annual renewal is mandatory under 21 CFR 807.22(b)(1). There are no grace periods and no extensions. The process:

1. Pay the fee: Access DFUF and pay the annual registration fee (on or after October 1)
2. Wait for PCN: Allow several days for payment processing and PCN delivery
3. Log into FURLS/DRLM: Select "Annual Registration"
4. Review all information: Verify establishment details, update any changes
5. Update device listings: Add new devices, inactivate discontinued ones, correct errors
6. Submit: Complete the renewal submission with valid PIN/PCN
7. Confirm: Print the renewal confirmation with new expiration date

Even if nothing has changed, you must click through and confirm registration each year. Failure to renew by December 31 means your registration lapses.

Consequences of Lapsed Registration

Common Registration and Listing Mistakes

Mistake 1: Paying the Fee Too Early

Paying before October 1 for annual renewal means your payment applies to the previous fiscal year. The PCN cannot be used for the current year's renewal. This is one of the most common errors and wastes significant money.

Mistake 2: Confusing Registration with Approval

Registration and listing do not mean your device is FDA-approved or FDA-cleared. Listing is not a premarket review. Companies that market devices as "FDA approved" based solely on listing face enforcement action.

Mistake 3: Missing the Renewal Window

The October 1 to December 31 window is firm. Even FDA system outages (as happened in late 2024 when the system went offline temporarily) do not extend the deadline. The regulatory clock does not stop.

Mistake 4: Incorrect Establishment Type Classification

Misclassifying your establishment type leads to incorrect obligations. For example, initial importers must register but are not required to list devices. Repackagers must both register and list. Understanding your exact role is essential.

Mistake 5: Duplicate FURLS Accounts

Creating a new FURLS account when one already exists creates confusion and compliance problems. Always check with your organization before creating a new account.

Mistake 6: Failing to Update Device Listings

Device listings must be kept current. Adding new devices, removing discontinued products, and correcting errors should happen promptly, not just during annual renewal.

Registration vs. Listing vs. Premarket Submissions: Key Differences

Practical Compliance Checklist

For New Establishments

• Determine establishment type and applicable obligations
• Appoint US Agent (if foreign establishment)
• Obtain product codes for all devices
• Complete premarket submissions and receive clearance/approval (if required)
• Access DFUF and pay registration fee
• Receive PIN and PCN
• Create FURLS account (or verify existing one)
• Register establishment in DRLM
• List all devices with required information
• Print and file confirmation documents

For Annual Renewal

• Calendar the October 1 – December 31 renewal window
• Pay the annual registration fee in DFUF on or after October 1
• Wait for PIN and PCN confirmation
• Review and update establishment information in FURLS/DRLM
• Add new devices, remove discontinued products
• Submit annual renewal with valid PIN/PCN
• Print renewal confirmation with new expiration date
• Verify US Agent information is current (foreign establishments)

For Establishments with Changes

• Update registration within 30 days of any change in ownership, location, or activities
• List new devices before commercial distribution
• Inactivate listings for discontinued devices
• Report changes to US Agent promptly
• Maintain documentation of all updates

FAQ

Do I need to register before submitting a 510(k)?

No. Establishment registration is not required before submitting a premarket application. You register and list after you begin commercial distribution. However, you must register within 30 days of starting covered operations.

Is the annual registration fee prorated?

No. The $11,423 fee (FY 2026) is a flat annual fee regardless of when during the fiscal year you register. There is no discount for partial-year registration and no small business reduction.

What happens if I miss the December 31 renewal deadline?

Your registration lapses. Foreign establishments face import detention. All devices from the unregistered establishment are considered misbranded under section 502(o). You must re-register and pay a new fee.

Do initial importers need to list devices?

No. Initial importers must register their establishment but are exempt from device listing requirements. They must register and pay the annual fee.

Can one FURLS account manage multiple facilities?

Yes. A FURLS account can manage multiple registered facilities through sub-accounts. Each facility requires its own registration, its own PIN/PCN, and its own annual fee payment.

How long does payment processing take before I receive my PCN?

Typically several business days. The FDA recommends paying well in advance of the December 31 deadline. Credit card payments may take a few extra days to clear.

Is there a penalty for late payment?

There is no specific late penalty, but your registration becomes inactive if not renewed by December 31. An inactive registration means you cannot legally import or distribute devices.

Can I use last year's PIN/PCN for this year's renewal?

No. Each fiscal year requires a new fee payment and a new PIN/PCN. The PIN/PCN from the previous year cannot be applied to the current renewal.

What if my device is Class I and 510(k)-exempt?

You still must register your establishment and list the device. The exemption is from the premarket notification requirement, not from registration and listing.

How does the QMSR (effective February 2, 2026) affect registration?

The Quality Management System Regulation (QMSR) does not directly change registration and listing requirements. However, QMSR compliance is considered during facility inspections, and unregistered establishments cannot be inspected through the normal process, which compounds compliance failures.

Where can I get help with registration and listing?

Contact the FDA Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or (800) 638-2041 for general device questions. For registration-specific assistance, email reglist@cdrh.fda.gov or call 301-796-7400.