What Is FDA FURLS?
FDA FURLS stands for FDA Unified Registration and Listing System. It is part of FDA Industry Systems and is used for important FDA registration and listing activities, including food facility registration, medical device registration and listing, and other FDA industry submissions. Companies must use the correct FDA module, account access, registration number, PIN, and renewal process to keep FDA records accurate.
Common FURLS Tasks
FURLS is the FDA System Behind Many Registration and Listing Filings
FURLS Means Unified Registration and Listing System
FURLS is FDA’s online registration and listing environment used for certain FDA-regulated industries. It is accessed through FDA Industry Systems and connects companies to modules used for specific FDA submissions.
Different Products Use Different Modules
Food facilities commonly use the Food Facility Registration Module, often called FFRM. Medical device companies use the Device Registration and Listing Module, often called DRLM. Other FDA-regulated submissions may use different FDA systems or modules.
Access Errors Can Cause Delays
Lost PINs, incorrect owner/operator access, old consultant accounts, wrong U.S. Agent information, duplicate registrations, or mismatched facility details can delay renewals, updates, imports, customer requests, and FDA communications.
FURLS Is Where FDA Registration Records Are Created and Maintained
FDA FURLS is not a certificate and it is not FDA approval. It is a government online system used to submit, manage, update, and renew certain FDA registrations and listings. A company may use FURLS when registering a food facility, managing a food facility renewal, linking a registration to an account, retrieving a PIN, or submitting medical device establishment registration and listing information.
The most common problem companies face is not simply creating an account. The problem is understanding which module applies, who should control the account, whether the correct facility is registered, whether the PIN is available, whether the U.S. Agent has confirmed the role, whether the DUNS/UFI details match, and whether the registration information matches import and customer documents.
FDA Registration Assistance helps companies navigate FDA FURLS and FDA Industry Systems for food facility registration, U.S. Agent service, renewals, account access issues, device registration and listing support, and registration record corrections.
How FDA FURLS Works
FDA Industry Systems Account
Before using many FDA Registration Modules, a company needs an FDA Industry Systems account. This account allows users to access available FDA systems and modules, including food facility registration and other electronic submissions.
Food Facility Registration Module
The Food Facility Registration Module, often called FFRM, is used for FDA Food Facility Registration. It is where companies can create, update, cancel, renew, link, and manage certain food facility registration records.
Device Registration and Listing Module
Medical device registration and listing information is submitted through FURLS using the Device Registration and Listing Module, or DRLM. Device companies must understand owner/operator access, official correspondent access, establishment registration, device listing, and annual renewal requirements.
Registration Number and PIN
Food facility records often involve a registration number and PIN. The PIN may be needed to access, link, update, or renew a facility registration. Losing control of the PIN or account can create delays during renewals or customer requests.
Subaccounts and Official Correspondents
In device registration, the owner/operator may create subaccounts for official correspondents. This allows another person or consultant to assist with device registration and listing without improperly sharing account credentials.
Updates and Renewals
FURLS is used not only for initial registration, but also for maintaining records. Food registrations may need updates and biennial renewal. Device establishments also have annual registration and listing responsibilities.
FDA FURLS Modules and What They Are Used For
| FDA System or Module | Common Use | Who Uses It | Common Mistake |
|---|---|---|---|
| FDA Industry Systems | Main account access point for FDA electronic industry submissions. | Food facilities, importers, device companies, consultants, and other FDA-regulated businesses. | Creating multiple accounts and losing track of which one controls the registration. |
| FURLS | FDA Unified Registration and Listing System used for certain registration and listing submissions. | Companies that must submit FDA registration or listing information through applicable modules. | Thinking FURLS itself is a certificate or proof of FDA approval. |
| FFRM | Food Facility Registration Module for food facility registration, updates, renewals, linking, and PIN-related tasks. | Domestic and foreign food facilities that manufacture, process, pack, or hold food for U.S. consumption. | Using the wrong facility address or failing to maintain U.S. Agent and DUNS/UFI details. |
| DRLM | Device Registration and Listing Module for medical device establishment registration and device listing. | Medical device manufacturers, specification developers, initial importers, relabelers, repackers, and other device establishments. | Paying a device user fee but not completing registration and listing correctly in DRLM. |
| Account Management | Used to create accounts, manage access, create subaccounts, and control who can make submissions. | Owners, operators, official correspondents, and authorized support providers. | Sharing login credentials instead of creating proper subaccount access when appropriate. |
| PIN Retrieval / Linking | Used to recover or connect food facility registration records to the correct account. | Facilities that lost account access, changed consultants, changed U.S. Agent, or need renewal access. | Waiting until renewal deadline or shipment issue before retrieving access. |
How FURLS is used for FDA Food Facility Registration
For food facilities, FURLS is most commonly discussed in connection with the Food Facility Registration Module. FDA’s online food facility registration process allows companies to create and manage food facility registration records. Foreign food facilities must also identify a U.S. Agent, and FDA may require confirmation of the U.S. Agent relationship.
Official FDA Resources for FURLS and Registration Systems
Companies should use official FDA systems and instructions when managing FDA registrations. FDA provides guidance for Food Facility Registration, FDA Industry Systems account creation, and medical device registration and listing.
FDA Industry Systems and Food Registration
FDA Industry Systems is the entry point for FDA electronic submissions, including food facility registration. FDA also provides online registration instructions for food facilities.
FDA Device Registration and Listing
FDA explains that medical device registration and listing information is submitted through FURLS using the Device Registration and Listing Module.
What Can Go Wrong with FURLS Access or Registration Records?
FURLS issues often become urgent during renewal season, when a shipment is delayed, when a customer requests proof of registration, when a broker asks for facility details, or when a company changes consultants or U.S. Agent. Access and accuracy matter because the registration record must support real business activity.
Common FURLS Mistakes Companies Make
Assuming FURLS Registration means FDA Approval
FDA registration through FURLS does not mean FDA approved the product, facility, label, claims, ingredients, device, drug, or shipment. Companies should avoid using registration as proof of FDA approval.
Losing Control of the FDA Account
Companies often lose access when a former employee, broker, or consultant created the original account. This can create problems during renewal, updates, PIN retrieval, or customer documentation requests.
Using The Wrong Module
Food, device, drug, cosmetic, and other FDA-regulated products do not all use the same registration process. Selecting the wrong system or module can create incomplete or incorrect compliance records.
Waiting Until Renewal Deadline
Renewal periods can become stressful when the PIN is missing, account access is lost, the U.S. Agent changed, or facility information does not match. Access should be confirmed before deadlines approach.
When Should a Company Fix FURLS Access or Registration issues?
Companies should fix FURLS access, registration, and listing issues before renewal deadlines, imports, customer audits, Amazon or retailer document requests, device annual registration, U.S. Agent changes, ownership changes, or facility address updates.
Need Help with FDA FURLS, Registration, or Account Access?
FDA Registration Assistance helps companies with FDA FURLS, FDA Industry Systems, Food Facility Registration, U.S. Agent service, DUNS/UFI support, food facility renewals, PIN and access issues, medical device registration and listing, registration updates, and compliance documentation.
FDA Registration Assistance is located in Miami, Florida, USA and assists companies nationwide and internationally. We have helped 1,000+ companies across 135+ countries with 15+ years of combined regulatory experience. Contact us at info@fdaregistrationassistance.com.
Frequently Asked Questions About FDA FURLS
1. What does FDA FURLS mean?
FDA FURLS means FDA Unified Registration and Listing System. It is used for certain FDA registration and listing submissions through FDA Industry Systems.
2. Is FURLS the same as FDA Industry Systems?
FURLS is part of the broader FDA Industry Systems environment. FDA Industry Systems is the access point for multiple FDA electronic submissions and account management functions.
3. What is FURLS used for?
FURLS is used for certain FDA registration and listing activities, including Food Facility Registration through FFRM and medical device registration and listing through DRLM.
4. What is FFRM?
FFRM means Food Facility Registration Module. It is the FURLS module used for FDA Food Facility Registration, updates, renewals, linking, and related food registration tasks.
5. What is DRLM?
DRLM means Device Registration and Listing Module. It is the FURLS module used for FDA medical device establishment registration and device listing.
6. Does FURLS registration mean FDA Approval?
No. FDA registration or listing through FURLS does not mean FDA approved, cleared, certified, or endorsed the product, facility, label, device, food, drug, or shipment.
7. Do Food Facilities use FURLS?
Yes. Food facilities commonly use the FURLS Food Facility Registration Module to create and manage FDA Food Facility Registration records.
8. Do Medical Device companies use FURLS?
Yes. Medical device registration and listing information is submitted through FURLS using the Device Registration and Listing Module.
9. What is an FDA Account ID?
An FDA account ID is used to access FDA Industry Systems. The account may control registration records, submissions, updates, and module access depending on the user role.
10. What is a Food Facility Registration PIN?
A registration PIN is used with food facility registration records. It may be needed to access, link, update, or renew a food facility registration.
11. Can I retrieve a lost FDA Food Facility PIN?
FDA provides PIN retrieval options for food facility registrations. If account access is complicated or the registration was created by another party, professional help may be needed to organize the process.
12. Can I link an existing registration to a new FDA account?
FDA provides functions for managing and linking registrations among accounts in certain situations. The process depends on account access, registration details, and PIN information.
13. What happens if my old consultant controls my FURLS account?
If a former consultant controls access, you may have trouble updating or renewing the registration. The company should recover proper access or link the registration to the correct account before deadlines or import issues arise.
14. Do Foreign Food Facilities need a U.S. Agent in FURLS?
Yes. Foreign food facilities that must register with FDA generally identify a U.S. Agent in the food facility registration record. FDA may require U.S. Agent confirmation.
15. What is the role of DUNS or UFI in FURLS?
FDA Food Facility Registration requires a Unique Facility Identifier, and DUNS is commonly used. The UFI information should match the facility’s legal name and physical address.
16. When do Food Facilities Renew Registration in FURLS?
FDA Food Facility Registrations must be renewed during FDA’s biennial renewal period between October 1 and December 31 of each even-numbered year.
17. When do Nedical Device Companies Update FURLS?
Medical device establishments generally manage annual registration and listing updates through DRLM. Device companies should also update information when establishment or listing information changes.
18. Is FURLS used to pay the Medical Device User Fee?
Medical device registration and listing are handled through DRLM in FURLS, but device user fee payment is handled separately through FDA’s device user fee payment process. Both steps may be needed.
19. Can a registration be updated after submission?
Yes. Many registration records can be updated when required information changes. Companies should update FDA records when facility details, contacts, U.S. Agent information, product categories, or listing information changes.
20. Can FDA Registration Assistance help with FURLS?
Yes. FDA Registration Assistance helps companies with FDA Industry Systems, FURLS, food facility registration, U.S. Agent service, DUNS/UFI support, medical device registration, listing support, renewals, and account access issues.
21. Can FURLS issues affect imports?
Yes. If facility registration information is missing, expired, inaccurate, or inconsistent with shipment documents, importers and brokers may face delays, document requests, or entry issues.
22. Should I share my FURLS login with a consultant?
Companies should be careful with account access. Where possible, proper account management or subaccount access should be used instead of sharing sensitive credentials unnecessarily.
23. What information should I prepare before using FURLS?
Useful information includes legal facility name, physical address, owner/operator details, emergency contact, U.S. Agent information if foreign, DUNS/UFI details, product categories, and any existing registration number or PIN.
24. Why should companies keep FURLS records current?
Current records help avoid renewal problems, import delays, customer documentation issues, FDA communication gaps, and mismatches between registration information and real business activity.
25. Why work with FDA Registration Assistance?
FDA Registration Assistance has helped 1,000+ companies across 135+ countries with 15+ years of combined regulatory experience. We help companies manage FDA FURLS, registration records, U.S. Agent support, renewals, listing issues, and system access problems.
