FDA Establishment Registration & Device Listing (FURLS)
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Determine which establishments must register and list, complete FURLS records, and coordinate annual renewal with the foreign establishment’s US Agent.
FDA establishment registration is separate from product authorization
Establishment registration identifies a business location and its regulated activities to the US FDA. Device listing identifies the devices associated with those activities. Neither registration nor listing means FDA has approved a facility or its products. A nonexempt device still needs the applicable 510(k) clearance, De Novo grant or PMA approval before commercial marketing.
Registration depends on what each establishment does. A distributor, importer, manufacturer and US Agent do not automatically have identical duties. Use FDA’s activity-based registration, listing and fee chart to evaluate every site.
Who must register, list and pay?
| Establishment activity | Registration | Device listing | Annual establishment fee |
|---|---|---|---|
| Finished-device manufacturer or specification developer | Generally required | Required | Generally required |
| Contract manufacturer or contract sterilizer of finished devices | Required | Required | Required |
| Repackager or relabeler | Generally required | Required | Generally required |
| Initial importer | Required | Identifies the foreign manufacturers; does not separately list their devices | Required |
| Domestic distributor that neither imports nor performs another regulated manufacturing activity | Generally exempt | Generally exempt | Generally exempt |
| US Agent acting only as the communications contact | The agent role alone does not trigger registration | No listing merely for acting as agent | No establishment fee merely for acting as agent |
These are common cases, not the entire exemption framework. Export-only activities, custom devices, components and other special circumstances need their own assessment. Exemption from premarket notification does not by itself exempt a manufacturer from registration or listing.
FY 2027 fee and annual renewal
The FDA fee schedule sets the annual establishment registration fee at US$13,785 for October 1, 2026–September 30, 2027. This government fee is separate from a consultant’s or US Agent’s service charge. Payment alone does not complete registration. A qualifying small business may apply for a financial-hardship waiver of the annual fee; it is not an automatic discount and does not cover initial registration.
Annual registration renewal runs from October 1 through December 31. FDA’s timing instructions distinguish initial registration from renewal: foreign establishments must register before exporting to the United States, and domestic initial importers before importing. Other initial registrations generally follow the specified 30-day activity rule. Do not use that period as permission to import before registration.
FURLS and DRLM submission checklist
- Confirm the legal owner/operator, physical establishments and activities. Check for an existing account before creating duplicate records.
- Pay the applicable fee through the Device Facility User Fee system and retain the payment identifiers.
- Use FDA Industry Systems to enter the Device Registration and Listing Module (DRLM). FURLS is the account environment; DRLM manages device registration and listing.
- Confirm the official correspondent, required facility identifiers, contact details and activities. For a foreign establishment, designate a US Agent and complete FDA’s consent verification.
- Associate devices with the correct product codes and marketing submission numbers, or document the applicable exemption. Confirm proprietary names and manufacturer/importer relationships.
- Submit and certify the completed record, save confirmation and verify the public registration/listing record after processing. Set reminders for renewal and required changes.
An owner/operator number, establishment registration number and FDA Establishment Identifier (FEI) serve different purposes. Do not describe the FEI as a newly issued seven-digit product approval. Likewise, UDI and GUDID obligations are separate from the DRLM device listing.
Responsibilities after registration
Give the official correspondent controlled account access and a clear approval process for updates. The US Agent is FDA’s US communications contact for the foreign establishment; it is not automatically the submission correspondent, initial importer or adverse-event reporter. Changes to establishment information, listing updates and annual certification should follow the applicable FDA instructions rather than one blanket deadline for every event.
Before the first shipment, check registration, device authorization, listing, labeling, importer arrangements and QMSR compliance together. Maintain complaint escalation and Medical Device Reporting procedures after launch. Pure Global can coordinate the administrative work while the manufacturer retains responsibility for accurate records and lawful marketing.
Coordinate the separate UDI and GUDID data workflow with the device listing and final labels.
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Plan your device registration, local representation and ongoing compliance with Pure Global.
Frequently asked questions
No. The payment must be followed by a completed electronic registration or renewal in DRLM. Retain the submission confirmation and verify the establishment record; a payment receipt is not FDA marketing authorization.
No. A domestic distributor with no importing or covered manufacturing activity is generally exempt. An initial importer, relabeler or other establishment with regulated activities may have registration and fee obligations. Assess actual activities using FDA’s chart.
Often yes. Premarket-notification exemption and establishment-registration exemption are separate questions. Confirm the product code’s exemption limitations, the establishment’s activity and all remaining general controls before supplying the device.
There is no automatic reduced establishment fee simply because a company qualifies for reduced submission fees. FDA may grant a qualifying financial-hardship annual-fee waiver under its program; initial registration is excluded.
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When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
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