US · FDA Establishment Registration & Device Listing
FDA Registration & Device Listing for Foreign Manufacturers
We guide foreign medical-device manufacturers through FDA establishment registration and device listing in FURLS/DRLM, including U.S. Agent designation and confirmation and the annual Oct 1–Dec 31 update cycle. The result: your establishment is properly registered and your devices are listed before they are imported into the U.S.—and you keep that status current year after year.
Foreign establishment registration
Device listing before import
U.S. Agent designation & 10-day confirmation
Annual Oct–Dec update cadence
What This Service Is About
If you manufacture medical devices outside the U.S. and want to place them on the U.S. market, you must register your establishment and list your devices with FDA. This is done in FDA’s online system FURLS/DRLM (Device Registration & Listing Module), and it must be maintained every year between October 1 and December 31. We help you plan what to register and list, designate a single U.S. Agent, complete the DRLM entries, and keep everything updated on schedule—without implying “FDA approval,” which registration and listing are not.
What You Will Receive
We focus on operational outcomes that make your registration, listings, and U.S. Agent setup clear and auditable.
Registration & Listing Plan (Foreign Establishment)
- Overview of which entities must register (foreign establishment view) and which devices must be listed.
- Roles and responsibilities between your team, U.S. Agent, and any internal stakeholders.
- Timeline for initial registration/listing (within 30 days of starting device operations) and the recurring Oct 1–Dec 31 annual update window.
U.S. Agent Workflow
- Step-by-step process to designate exactly one U.S. Agent, including required contact details.
- Template language for appointment/confirmation so expectations are clear.
- Highlight of the 10-business-day confirmation rule: what the U.S. Agent must do and what happens if they do not confirm.
DRLM Walkthrough (FURLS/DRLM)
- Field-by-field guidance for the Device Registration & Listing Module (we advise; you hold and control the account).
- Practical notes so establishment details, device listings, and U.S. Agent information are consistent.
- Cross-check of entries against your internal product list and regulatory strategy.
Annual Cycle Checklist
- Oct–Dec annual review steps to confirm establishment data, device listings, and U.S. Agent details.
- Reminders to complete user-fee obligations where applicable.
- Simple calendar and task list to keep the annual update from slipping.
Listing Hygiene Worksheet
- Concise worksheet to track device identifiers, product codes, and listing numbers.
- Change-log section to note near-term updates (new models, retired SKUs, code corrections) so listings stay aligned with reality.
How the Service Works
We turn FDA’s registration and listing requirements into a clear, repeatable process for your team.
Discovery
- Confirm which legal entities are “establishments” in FDA’s terms and which devices are in scope.
- Review your current FDA status (if any) and upcoming milestones.
U.S. Agent Designation & Confirmation Plan
- Define or validate your U.S. Agent choice (a U.S.-based contact that facilitates FDA communications).
- Prepare language and steps for adding the U.S. Agent in DRLM, including how they will complete the required confirmation within 10 business days.
DRLM Entries & Initial Registration/Listing
- Walk through the FURLS/DRLM fields for establishment registration and device listing (you retain account access and submit data).
- Align listings with device identifiers, product codes, and import plans; ensure devices are listed and made at a registered establishment before import.
Annual Oct–Dec Cadence
- Set up an annual Oct 1–Dec 31 review and update routine so registrations and listings stay active.
- Provide checklists and reminders for contact changes, new or retired devices, and any required updates to your U.S. Agent information.
What We Need From You
We keep your effort focused on the facts only you can provide.
- Foreign establishment details (legal name, address, role) and access to your FURLS/DRLM account.
- Proposed U.S. Agent details (name, address, phone, email) or a request to use a separate U.S. Agent service.
- List of devices to be placed on the U.S. market, including identifiers and intended product codes where known.
- Current registration/listing status (if any) and any upcoming U.S. launch or update dates.
- Internal contacts for escalation and decision-making (e.g., who approves listings, who responds to FDA notices).
Consulting and documentation only. You control your FURLS/DRLM account, submit all data, and pay FDA user fees where applicable. FDA registration and listing do not mean your device is approved or cleared.
FREQUENTLY ASKED QUESTIONS
Yes. A foreign establishment that imports or offers devices for import into the U.S. must designate exactly one U.S. Agent and provide their contact details in the registration.
After you designate the U.S. Agent, they must confirm within 10 business days. If they do not, the system cancels the association and you must amend your registration to correct it.
You must complete initial registration and listing within 30 days of starting device operations for the U.S. market. After that, you must review and update registration and listing every year during the Oct 1–Dec 31 annual registration window.
No. A device made by a foreign establishment may not be imported or offered for import unless the establishment is registered and the device is listed.
No. Being “registered” or “listed” does not mean FDA has approved, cleared, or endorsed your device. It only means your establishment and devices appear in FDA’s databases as required.
FURLS is FDA’s Unified Registration and Listing System. DRLM (Device Registration & Listing Module) is the specific module in FURLS used to submit establishment registrations and device listings.
The annual registration window is the period from October 1 to December 31 each year when all active establishments must review and update their registration and listing information to remain current.
Make Your U.S. Entry Clean and Compliant
If you are a non-U.S. manufacturer placing devices on the U.S. market, registering your establishment, listing your devices, and designating a U.S. Agent are not optional—they are prerequisites. We help you understand what must be registered and listed, set up a compliant U.S. Agent workflow with the 10-day confirmation, guide your DRLM entries, and lock in an annual Oct–Dec routine so your status stays active and defensible.
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