Device Listing

Device Listing is an FDA requirement under 21 CFR Part 807 Subpart E that requires manufacturers and initial distributors to provide FDA with a list of all devices they have in commercial distribution. Device listing is separate from but related to establishment registration and is managed through FDA's Unified Registration and Listing System (FURLS).

Legal requirement:
- Required under 21 CFR 807.20
- Applies to manufacturers and initial distributors
- Covers devices in commercial distribution
- Must be updated regularly
- Separate requirement from establishment registration

Who must list devices:

Domestic manufacturers:
- Must list all devices manufactured at registered establishment
- Includes contract manufacturers
- Applies to all device classes (I, II, III)

Foreign manufacturers:
- Must list devices exported to USA
- Listing done by U.S. agent or importer
- Initial distributor may list if manufacturer doesn't

Initial distributors (importers):
- Must list if foreign manufacturer doesn't list
- Becomes owner's responsibility after import

FURLS system:
The FDA Unified Registration and Listing System (FURLS) is the electronic system for:
- Establishment registration
- Device listing
- U.S. agent designation
- Official correspondent designation
Replaced previous paper and CD-ROM submission methods

Information required for device listing:

1. Device identification:
- Proprietary (brand) name
- Common or usual name
- Classification name
- Device class (I, II, or III)

2. Product codes:
- FDA product code (3-letter code)
- Identifies device type
- Determines regulatory requirements

3. Premarket submission:
- 510(k) number (if applicable)
- PMA number (if applicable)
- De Novo number (if applicable)
- Exemption status (if applicable)

4. Commercial distribution status:
- Whether device is in commercial distribution
- GMPs applicable (yes/no)
- Contract manufacturer information (if applicable)

5. Additional information:
- Package types and sizes
- Whether device is imported
- Whether device is exported

Timing requirements:

Initial listing:
- Within 30 days of first commercial distribution
- At time of establishment registration for new manufacturers
- Before first shipment for new devices

Annual renewal:
- October 1 through December 31 each year
- Must update even if no changes
- Failure to renew may result in delisting

Updates required:
- New devices added to listing within 30 days
- Discontinued devices should be updated
- Changes to premarket status (new 510(k), etc.)

Proprietary vs. common name:

Proprietary name:
- Brand name or trademark
- Company's commercial name for device
- May be multiple proprietary names for same device

Common or usual name:
- Generic name describing device
- Not trademarked
- Understandable to healthcare professionals

Classification name:
- Official FDA regulatory classification
- Identifies device type per 21 CFR 862-892

Relationship to establishment registration:

Establishment registration:
- Registers the facility/location
- Required before device listing
- Annual renewal required

Device listing:
- Lists specific products made at facility
- Tied to registered establishment
- Identifies what is manufactured where

Both are required - you cannot list devices without first registering the establishment.

Exemptions from listing:

Devices exempt from listing requirements:
- Devices for export only (some exceptions)
- Custom devices (made to individual order)
- Investigational devices not yet in commercial distribution
- Components or parts intended for further manufacturing
- Devices manufactured for internal use only

Device listing fees:
As of 2024, FDA device listing is free - there is no fee for submitting or updating device listings (unlike establishment registration which has an annual fee).

Public accessibility:

Information available to public:
- Proprietary and common names
- Device classification
- Product code
- Premarket submission numbers
- Manufacturer/distributor information

Searchable databases:
- FDA Device Listing Database
- FDA 510(k) Database
- FDA PMA Database
- Manufacturer's name and products visible

Consequences of non-listing:

Failure to properly list devices may result in:
- Warning letters from FDA
- Devices deemed misbranded
- Import detention
- Inability to legally market device
- Enforcement actions
- Potential product recalls

Changes requiring listing updates:

New device:
- Different intended use
- Different technological characteristics
- New brand name
- Different model number

Device modifications:
- Change in premarket status (new 510(k) cleared)
- Change in classification
- Change in product code

Ownership/business changes:
- Change in manufacturer
- Change in initial distributor
- Acquisition or merger
- Change in establishment location

Discontinued devices:
- Device no longer commercially distributed
- Should be marked as discontinued
- Removal from listing not automatic

Device listing for combination products:

Devices that are combination products (drug-device, biologic-device):
- Lead center determines listing requirements
- Device constituent may require device listing
- Drug or biologic constituent has separate listing requirements
- Consult FDA Office of Combination Products

Contract manufacturing:

Contract manufacturer responsibilities:
- Must register establishment
- Must list devices they manufacture
- List devices under own establishment number
- Indicate contracted/OEM manufacturing

Brand label holder:
- Also lists same devices
- Under their establishment number
- Identifies contract manufacturer in listing

Same device appears in listings for both contract manufacturer and brand owner.

Import and export considerations:

Imported devices:
- Foreign manufacturer should list via U.S. agent
- Or initial distributor (importer) lists devices
- Must indicate device is imported

Exported devices:
- Generally exempt from listing if for export only
- Exception: devices also sold in U.S. must be listed
- Export-only drugs have different rules

U.S. Agent role:
- Can submit device listing on behalf of foreign manufacturer
- Named in FURLS system
- Receives FDA communications

Common mistakes:

• Confusing establishment registration with device listing
• Missing 30-day deadline for new devices
• Not updating annual listing during October-December
• Incorrect product code selection
• Missing 510(k) numbers
• Not updating when devices discontinued
• Listing components instead of finished devices
• Not listing all device variations/models

Best practices:

• Maintain internal database of all devices
• Assign person responsible for FURLS updates
• Calendar reminders for annual renewal period
• Document all listing submissions
• Regular audits to ensure accuracy
• Train relevant personnel on requirements
• Review FDA product code classification
• Coordinate with contract manufacturers
• Update promptly when changes occur

FURLS system access:

Account setup:
- Create FDA Industry Systems account
- Verify email address
- Designate official correspondent
- Assign FURLS administrator

User roles:
- Official correspondent (highest authority)
- FURLS administrator (manages listings)
- Additional users as needed
- Security credentials required

Relationship to other FDA databases:

Device listing feeds into:
- FDA Device Registration and Listing Database (public)
- FDA Establishment Inventory (internal)
- Import screening systems
- Recall databases
- Post-market surveillance systems

Accurate device listing ensures proper FDA oversight and enables the agency to identify manufacturers quickly in case of safety issues, recalls, or other post-market events.