Completing FDA Establishment Registration and Device Listing

Summary: The FDA requires all medical device establishments to complete the establishment registration and device listing electronically through the FDA Unified Registration and Listing System (FURLS) using the Device Registration and Listing Module (DRLM). Registration isn’t complete until the annual establishment fee is paid, and all relevant device information is listed.

Establishments must also keep their information current—updating FURLS whenever a new device is introduced, a manufacturing location changes, or a product is withdrawn or reinstated. For foreign manufacturers, appointing a qualified U.S. Agent is mandatory to ensure prompt and effective communication with the FDA.

Submitting Establishment Registration & Device Listing via FURLS

All medical device registrations and listings must be submitted electronically through the FDA Unified Registration and Listing System (FURLS), using the Device Registration and Listing Module (DRLM).

To begin, create a FURLS account, designate an official correspondent, and pay applicable fees. Link to FURLS Access. To check on FURLS account access, contact the registration and listing office at reglist@cdrh.fda.gov.

Annual Registration User Fee

Each registered establishment must pay an annual, non-refundable registration fee. Registration is not complete until payment is received.

• The fiscal year 2026 fee (October 1, 2025 – September 30, 2026) is $11,423.
• All establishments must pay this fee; however, starting in FY 2026, qualifying small businesses may be eligible for a waiver.
• Payment is processed electronically through the Device Facility User Fee (DFUF) system.
• Although small businesses may receive fee reductions for certain submissions (e.g., 510(k) or PMA), no discount applies to the annual establishment registration.

Payment: Manufacturers pay fees electronically through the FDA’s Device Facility User Fee (DFUF) system. Small businesses can qualify for reduced fees of 510(k), PMA, and other submissions, but no discount applies to establishment registration.

Updating Establishment Registration and Device Listing

Owners and operators can log in to FURLS at any time during the year to update their registration and device listing information as changes occur. For example, updates may include:

• Introducing a new device into commercial distribution
• Modifying details about an existing device, such as its manufacturing location
• Removing a device from commercial distribution—or resuming its distribution

Medical device establishment registration follows the FDA’s fiscal year, which runs from October 1 to September 30. However, the FDA considers each registration active through the end of the calendar year.

U.S. Agent Requirement for Foreign Firms

Whenever a foreign establishment manufactures a medical device for import into the United States, U.S. FDA regulations require the facility to designate a United States Agent. This Agent then serves as the FDA’s official liaison with the foreign establishment.

Because FDA communications may be time‑sensitive, the U.S. Agent must:

• Be physically located in the United States—maintaining a valid U.S. address (not a P.O. box or answering service) and available during normal business hours.
• Develop a strong understanding of FDA medical device regulations and actively advise foreign establishments on compliance matters.
• Assist in FDA communications, respond to questions about the foreign establishment’s device imports, and help coordinate inspections.
• Act as the recipient for FDA notices when direct contact with the foreign establishment isn’t feasible, since receiving these notices counts as contacting the facility directly.

Furthermore, appointing an independent U.S. Agent—rather than a trading partner or distributor—helps avoid conflicts of interest and ensures unbiased, reliable regulatory support.

Under Title 21 CFR Part 807, foreign establishments that manufacture, prepare, process, compound, or package medical devices for the U.S. market must follow this requirement.

Contact Information for Assistance

For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at Phone: 301-796-7400 or email: reglist@cdrh.fda.gov

For assistance with policy or detention issues, please contact the Registration and Listing Staff at Phone: 301-976-7400 or Email: device.reg@fda.hhs.gov

To register a medical device establishment with the US FDA, follow the steps outlined in the checklist below.

Conclusion

Accurate and timely establishment registration demonstrates your company’s commitment to quality and regulatory compliance. By maintaining active registration, paying annual fees, and designating the right U.S. Agent, manufacturers can avoid delays, prevent compliance risks, and sustain uninterrupted access to the U.S. market. Read EnPak LLC’s blog Understanding U.S. FDA Medical Device Establishment Registration.

EnPak LLC supports manufacturers through every step of the registration and listing process—ensuring your compliance documentation is accurate, current, and audit-ready. Learn more about our services.

Additional Resources

FDA Device Registration and Listing
Who Must Register, List and Pay the Fee
When to Register and List
Establishment Registration and Device Listing
Definitions of Establishment Activities
FURLS System Access
Title 21 CFR Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices