FDA Establishment Registration

FDA Establishment Registration is a fundamental compliance requirement under 21 CFR Part 807, requiring every domestic and foreign establishment engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for commercial distribution in the United States to register annually with the FDA.

Regulatory basis:

21 CFR Part 807 - Establishment Registration and Device Listing:
This regulation establishes the requirements for registration of device establishments and listing of devices with the FDA. Registration ensures FDA knows who is making medical devices and where they are located, enabling effective oversight and inspection planning.

FURLS - FDA Unified Registration and Listing System:
FDA's electronic system for establishment registration and device listing. FURLS replaced the older DRLS system and provides a centralized platform for manufacturers, importers, and initial distributors to fulfill registration and listing obligations.

Who must register:

Domestic establishments:
- Device manufacturers (all classes)
- Contract manufacturers
- Repackagers and relabelers
- Specification developers (in certain cases)
- Reprocessors of single-use devices
- Initial importers (U.S. receiving point for foreign devices)

Foreign establishments:
All foreign facilities that export devices to the United States must:
- Register their establishment with FDA
- Designate a U.S. Agent for FDA communications
- List all devices manufactured at that facility
- Maintain current registration annually

When registration is required:

Initial registration:
Must be completed before:
- Beginning manufacturing operations
- Importing devices into the United States
- Introducing devices into interstate commerce

Timing: Registration must be submitted at least 5 days before devices are introduced into U.S. commerce, though FDA recommends submitting earlier to avoid delays.

Annual registration renewal:

October 1 - December 31 deadline:
All registered establishments must:
- Renew registration annually between October 1 and December 31
- Update any changes to establishment information
- Verify device listing information is current
- Pay applicable user fees (for certain establishments)

Failure to renew by December 31 results in automatic cancellation of registration.

Registration fees:

Fee structure (subject to annual adjustment):
- Initial registration - Currently exempt from fees
- Annual renewal - Most establishments exempt
- Foreign establishments - Generally exempt
- User fees - Apply to certain submission types (510(k), PMA), not registration itself

Exception: Small businesses and certain establishment types may qualify for fee waivers or exemptions.

Information required for registration:

Establishment information:
- Official establishment name and trade names
- Physical address and mailing address
- Owner/operator name and contact information
- Type of ownership (corporation, partnership, individual)
- Business trading activity (manufacturer, importer, etc.)
- Registration number (assigned by FDA after initial submission)

Foreign establishment additional requirements:
- U.S. Agent designation with full contact information
- U.S. Agent acceptance of designation
- Country of establishment location
- Preferred language for FDA communications

U.S. Agent requirements for foreign establishments:

Who can be a U.S. Agent:
- Individual residing or maintaining place of business in U.S.
- U.S. business entity
- Cannot be the foreign establishment itself
- May represent multiple foreign establishments

U.S. Agent responsibilities:
- Serve as communication link between FDA and foreign establishment
- Receive and respond to FDA communications
- Assist FDA in scheduling inspections
- Available during normal business hours
- Does not need technical knowledge of devices

Important: U.S. Agent does not need to be involved in device distribution or sales - role is purely regulatory communication.

Device listing obligations:

Registration and device listing are interconnected:
- All registered establishments must list devices they manufacture
- Device listing includes product codes, device names, and classification
- Listing must be updated when new devices introduced
- Listing must be updated within 30 days of changes
- Separate requirement from registration but submitted through FURLS

Registration changes and updates:

Required updates within 30 days:
- Change of establishment name or address
- Change of owner or operator
- Change of U.S. Agent (foreign establishments)
- Change in business trading activities
- Addition of new device types

No fee for updates: Changes to existing registrations do not incur additional fees.

Registration cancellation:

When to cancel:
- Establishment ceases all device activities
- Permanent closure of facility
- Transfer of operations to another location
- Business dissolution

Voluntary cancellation: Must submit cancellation request through FURLS before automatic annual expiration.

Consequences of non-registration:

Enforcement actions:
- Devices considered misbranded under Section 502(o) of FD&C Act
- Subject to import refusal at U.S. borders
- Warning letters and regulatory actions
- Potential product seizures
- Injunctions and prosecution for continued violations
- Inability to legally market devices in U.S.

Import alerts: Foreign establishments without proper registration may be placed on import alert, resulting in automatic detention of shipments at U.S. ports of entry.

Registration vs. other FDA requirements:

Registration does NOT:
- Constitute FDA approval or endorsement
- Satisfy premarket submission requirements (510(k), PMA)
- Replace QSR compliance obligations
- Exempt from Medical Device Reporting (MDR)
- Substitute for unique device identification (UDI) requirements

Registration IS:
- A separate compliance requirement
- Mandatory regardless of device class
- Required before premarket submissions
- Subject to annual renewal
- Essential for legal U.S. marketing

Inspection implications:

Routine inspections:
Registered establishments are subject to FDA inspections:
- Domestic facilities - biennial inspection cycle (risk-based)
- Foreign facilities - FDA can request inspection through U.S. Agent
- Failure to register prevents FDA from conducting surveillance
- Registration information used to prioritize inspection targets

Common registration mistakes to avoid:

Incomplete information:
- Missing or incorrect physical address
- Inadequate owner/operator details
- Invalid U.S. Agent contact information
- Failure to list all device types manufactured

Timing errors:
- Registering too late (after commercial distribution begun)
- Missing annual renewal deadline (October 1 - December 31)
- Not updating changes within 30 days
- Delayed initial registration before device listing

Misunderstanding scope:
- Thinking registration equals FDA approval
- Assuming contract manufacturers don't need registration
- Believing only manufacturers of Class III devices must register
- Not registering specification developers when required

FURLS system specifics:

Electronic submission requirements:
- All registrations must be submitted electronically through FURLS
- Paper submissions no longer accepted (except in rare circumstances)
- SPL (Structured Product Labeling) format for device listing
- Digital certificates may be required for submission

Account management:
- Establishments need to create FURLS account
- Username and password credentials required
- Security questions for account recovery
- Multiple users can access same establishment account

Registration and international markets:

Mutual recognition:
Some countries may:
- Accept FDA registration as supporting evidence
- Require similar establishment registration in their jurisdictions
- Use MDSAP audits to satisfy both FDA and local requirements
- Reference FDA registration in Free Sales Certificates

Not equivalent to:
- EU Authorized Representative registration
- Brazilian ANVISA registration (AFE)
- Canadian MDEL
- Australian TGA registration

Each jurisdiction has separate establishment registration requirements.

FDA Establishment Registration is a critical foundational requirement for all device manufacturers and importers operating in the U.S. market. Compliance ensures regulatory visibility, enables FDA oversight, and is legally required for device distribution in the United States.