What Is FDA Device Registration and Listing? Complete 2025 Guide
- Beng Ee Lim
- 13 hours ago
- 5 min read
FDA device registration and listing is a mandatory annual process where medical device companies register their facilities and list their specific products with FDA. Registration identifies WHO makes devices, while listing identifies WHAT devices are made. Both are required before commercial distribution in the US.
This guide covers requirements, deadlines, fees, and step-by-step compliance to help you avoid delays and maintain market access.
What Is FDA Device Registration and Listing?
FDA device registration and listing are two separate but connected requirements under 21 CFR Part 807. Many companies confuse these processes, but understanding the distinction is critical for compliance.
Establishment Registration identifies your facility to FDA. It declares who is responsible for manufacturing, processing, or distributing medical devices. Think of it as registering your business identity with FDA.
Device Listing identifies your specific products. It declares exactly what devices you're manufacturing or distributing, including product codes, brand names, and submission numbers.
Both processes use FDA's Unified Registration and Listing System (FURLS) through the Device Registration and Listing Module (DRLM).
Who Must Register and List with FDA?
Registration and listing requirements apply to any person engaged in device activities intended for US distribution, including:
Domestic Companies:
Manufacturers of medical devices
Contract manufacturers and sterilizers
Repackagers and relabelers
Specification developers
Foreign Companies:
Device manufacturers exporting to the US
Contract manufacturers serving US companies
Initial importers of foreign devices
Key Point:Â Foreign manufacturers must appoint a US Agent before registration. This agent serves as FDA's primary contact and must be available during US business hours.
Even companies that only develop specifications while outsourcing manufacturing must register if their devices will be sold in the US.
Registration vs. Listing: Key Differences
Aspect | Registration | Listing |
Purpose | Identifies WHO (facility/company) | Identifies WHAT (specific devices) |
Scope | One per establishment | One per device type |
Information Required | Facility details, ownership, activities | Product codes, brand names, submission numbers |
Annual Fee | $9,280 (FY 2025) | Included in registration fee |
Timing | Before commercial distribution begins | Before each device enters market |
When You Must Register and List
Initial Registration Timing: Registration and listing must be submitted within 30 days of beginning device activities or commercial distribution. For foreign establishments, registration must be completed before exporting products to the US.
Important:Â If a device needs 510(k), De Novo, PMA, PDP, or HDE, you cannot list it until FDA clears/approves/grants the submission.
Annual Renewal Requirements: All registrations must be renewed annually between October 1 and December 31, regardless of when you initially registered. This aligns with FDA's fiscal year (October 1 - September 30).
Missing the December 31 deadline results in expired registration and loss of market access until re-registration is completed.
FDA Registration and Listing Fees for 2025
Annual Registration Fee:Â $9,280 (FY 2025)
This fee applies to all registered establishments regardless of company size. There are no small business exemptions or fee reductions.
Payment Process:
Pay the annual establishment fee in the Device Facility User Fee (DFUF)Â website.
You’ll receive a Payment Identification Number (PIN) and, once payment posts, a Payment Confirmation Number (PCN) by email.
In FURLS → DRLM, enter both PIN and PCN to complete registration.
Registration cannot be completed without a valid PIN and PCN for the correct fiscal year.
Fee Payment Timing:Â Don't pay before October 1 for renewal, as early payments apply to the previous fiscal year and cannot be used for the current renewal.
Step-by-Step Registration Process
Step 1: Determine Your Requirements
Classify your device and identify product codes
Determine if premarket submission is required
Appoint US Agent (foreign companies only)
Step 2: Gather Required Information
Facility details and ownership structure
Manufacturing activities performed
Device information including brand names
Premarket submission numbers (if applicable)
Step 3: Access FURLS System
Create FDA account through FURLS portal
Navigate to Device Registration and Listing Module
Step 4: Complete Registration
Enter establishment information
Submit registration form with PCN
Step 5: Complete Device Listings
List each device with required details
Include product codes and proprietary names
Specify activities performed on each device
Common Registration and Listing Mistakes
Misclassifying Your Device
Using incorrect product codes leads to wrong regulatory pathways and potential delays. Verify classification through FDA's device database or consider a 513(g) classification request.
Incomplete Device Information
Missing proprietary names, incorrect submission numbers, or incomplete activity descriptions can trigger FDA review delays.
Missing Renewal Deadlines
Failing to renew between October 1 and December 31 results in expired registration. Late renewals require complete re-registration with new registration numbers.
US Agent Issues (Foreign Companies)
Appointing an inappropriate US Agent or failing to maintain current contact information creates compliance gaps. US Agents must be available during business hours and knowledgeable about your devices.
Documentation Problems
Maintaining incomplete records or failing to update changes promptly can complicate FDA inspections and audits.
Foreign Manufacturer Requirements
Foreign establishments have additional requirements beyond domestic companies:
US Agent Appointment
Every foreign establishment must appoint a US Agent who:
Resides or maintains place of business in the US
Is available during normal business hours
Can communicate in English
Is knowledgeable about device registration and listing
Pre-Export Registration
Foreign facilities must register before any device may be imported or offered for import into the United States.
Communication Requirements
All FDA correspondence goes through the designated US Agent, making this appointment critical for maintaining compliance.
Annual Renewal Process
Renewal Timeline:
October 1: Renewal period opens
Early November: Recommended completion timing
December 31: Final deadline (11:59 PM)
Renewal Requirements:
Review and update facility information
Verify device listings remain current
Pay annual fee and obtain new PCN
Submit renewal through FURLS system
System Considerations: FDA's renewal system experiences heavy traffic in December. Complete renewals early to avoid technical issues and processing delays.
Registration vs. FDA Approval
Critical Distinction:Â Registration and listing do NOT constitute FDA approval or clearance.
Companies cannot market devices as "FDA approved" or "FDA cleared" based solely on registration. These terms apply only to devices that have received:
Registration simply notifies FDA of your facility and products. Marketing claims must reflect actual regulatory status.
Maintaining Ongoing Compliance
Update Requirements:
Changes must be reported within 30 days for:
Ownership or facility location changes
New devices entering commercial distribution
Discontinued devices
Manufacturing activity changes
Record Keeping:
Maintain comprehensive documentation including:
Registration certificates and correspondence
Payment confirmations and receipts
Device listing details and updates
US Agent agreements (foreign companies)
Quality Management System: Registration establishes FDA oversight, making Quality Management System (QMS) compliance under 21 CFR Part 820 essential for continued market access.
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Frequently Asked Questions
How much does FDA device registration cost?
The annual registration fee is $9,280 for FY 2025, with no exemptions based on company size.
When do I need to register with FDA?
Within 30 days of beginning device manufacturing, processing, or commercial distribution activities.
What happens if I miss the renewal deadline?
Registration expires, prohibiting commercial distribution until re-registration is completed with a new registration number.
Can I register before getting 510(k) clearance?
You can register your establishment, but cannot list devices requiring premarket submission until FDA grants clearance or approval.
Do I need separate registrations for multiple facilities?
Yes, each facility performing device activities requires separate registration.
How long does registration take?
Initial registration with complete documentation typically processes within days. Complex submissions may take longer.