Every foreign establishment that manufactures, prepares, propagates, compounds, assembles, or processes a medical device imported or offered for import into the United States must register annually with FDA and list its devices. Foreign establishments must also designate a US Agent. Registration and listing live in the FURLS/DRLM system; a separate annual establishment registration fee applies to most device types.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • FDA establishment registration is the administrative step that tells FDA who you are, where you manufacture, and what you make — it is not device clearance or approval.
  • The legal basis sits in Section 510 of the Federal Food, Drug, and Cosmetic Act; implementing regulations are in 21 CFR Part 807 .
  • Foreign establishments must designate a US Agent physically located in the United States as a condition of registration.
  • Registration is annual, runs on the federal fiscal year (October 1 – September 30), and is accompanied by an annual establishment registration user fee .
  • Device listing is a separate, linked action: every device produced by the establishment must be listed with its proprietary name, product code, and premarket submission reference (510(k) number, PMA number, or exempt status).
  • Registration alone does not authorize marketing; you still need the correct premarket pathway (510(k), De Novo, PMA, or exemption).

Why this matters

Every year Tibor fields the same call from European founders in January or February: "We just got a letter from our US distributor — FDA says our registration expired. We cannot ship. What do we do?" The fix is usually quick. The lost revenue during the ship-stop rarely is.

Establishment registration is one of the cheapest, simplest, and most commonly mishandled pieces of the US regulatory puzzle for EU manufacturers. It is cheap because the fee is bounded and predictable. It is simple because the data you enter is mostly already in your CE technical file. It is mishandled because founders treat it as a one-time onboarding task — check the box, move on — rather than a recurring obligation with a hard annual deadline and a real enforcement consequence.

This post is the no-nonsense version of what every EU Class I, Class II, and Class III manufacturer shipping to the US needs to do, in what order, for how much.

What FDA actually requires

Section 510 of the Federal Food, Drug, and Cosmetic Act requires owners or operators of establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a device to register annually. 21 CFR Part 807 Subpart B lays out the procedure . Foreign establishments are covered in 21 CFR Part 807 Subpart D, which also requires designation of a US Agent .

Registration happens electronically through the FDA Unified Registration and Listing System (FURLS), specifically the Device Registration and Listing Module (DRLM). You create an FDA account, create an establishment record, designate your US Agent, pay the annual establishment registration fee, and list your devices.

The fee is set annually under the Medical Device User Fee Amendments (MDUFA) cycle. For FY2026 it sits in the low five-figure USD range . Unlike the 510(k) fee, there is no "small business" reduction for establishment registration — the fee is flat and annual.

The MDR parallel (brief)

Under MDR (EU) 2017/745, Article 29 requires registration of manufacturers, authorized representatives, and importers in Eudamed. Article 31 requires submission of information including the SRN. There is no recurring annual fee; the data lives in Eudamed and is updated when facts change. The administrative philosophies are different: FDA runs an annual "re-up" cadence; MDR runs a "notify when changed" cadence. Do not assume one satisfies the other. They do not.

A worked example

A 14-person Austrian startup produces a Class IIa reusable surgical instrument. They CE marked under MDR with a Notified Body in 2024 and started shipping in the EU in early 2025. Their US distributor, identified in mid-2025, wants to start importing in January 2026 after the 510(k) clearance is expected in December 2025.

Here is what has to happen on the FDA registration side, in order:

  1. Appoint a US Agent before anything else. The US Agent must have a physical US address and must be reachable by phone during business hours. The distributor can act as US Agent, but this creates a conflict of interest the founders should think hard about. Many EU startups use an independent US Agent service for 1,000–3,000 USD per year.

  2. Create an FDA account in the FURLS system. One account per company. The account owner is the person responsible for the establishment record — typically the CEO, the regulatory lead, or the PRRC under MDR Article 15 if that person also handles US affairs.

  3. Create the establishment record in DRLM. Enter the legal name, physical manufacturing address (the actual factory, not a PO box), and contact information. Designate the US Agent and confirm that person has accepted the role.

  4. Pay the annual establishment registration fee via the FDA user fee website. The confirmation number links the payment to the establishment record. No fee, no active registration.

  5. List the devices under the establishment. For each device you need: the proprietary name, the model or catalogue number, the FDA product code (three-letter code from the product classification database), and the premarket submission reference. For the Austrian startup's Class IIa instrument, the product code is likely a "G" or "H" prefix code — pull it from FDA's product classification database, not from memory.

  6. Link the 510(k) once cleared. Until the 510(k) is cleared, the device cannot lawfully be imported, even if the establishment is registered. Registration is a prerequisite, not a permission.

  7. Renew every October. The renewal window opens October 1 and closes December 31. Miss it and your registration lapses — which means your devices cannot lawfully enter the US until you re-register and re-pay.

Total direct cost for year one: establishment fee + US Agent retainer + a few hours of a regulatory lead's time. Total savings versus the "oh no we are not registered" fire drill in February: substantial.

The Subtract to Ship playbook

1. Register once you have a US go-to-market decision, not before. Paying an annual fee for an establishment you are not yet shipping from is waste. Paying it the month before your first shipment is exactly right.

2. Do not let the distributor be your US Agent. The US Agent is FDA's direct line to you for questions, inspection notices, and warning letters. If that line runs through your commercial partner, you lose information control. Use an independent service. The fee difference is noise.

3. Make renewal part of your annual QMS cycle. Add "FDA establishment registration renewal" to the October agenda of your management review under EN ISO 13485:2016+A11:2021. Do not rely on an individual's memory.

4. List devices precisely. The product code drives which FDA regulations, standards, and guidance apply to your device. A wrong product code is not just a data error — it signals to FDA that you do not understand your own regulatory classification. Use FDA's product classification database and, if in doubt, use a Q-Sub to confirm.

5. Keep Eudamed and FURLS synchronized in spirit, not in copy-paste. The data elements overlap but the systems expect different formats. Do not assume Eudamed entries transfer. Treat them as two separate records of the same truth.

6. Maintain a single source of truth internally. One spreadsheet or eQMS entry that lists: establishment name, address, US Agent name and contract expiry, FURLS account owner, last renewal date, next renewal due date, devices listed, product codes, 510(k) numbers. Nothing more, nothing less.

Reality Check

  1. Do you know whether you are legally required to register with FDA — i.e., are you manufacturing devices that will be imported into the US?
  2. Have you designated a US Agent that is independent from your commercial distributor?
  3. Is your FURLS account owner a current employee with a working email address?
  4. Do you know your annual renewal deadline and which person is accountable for it?
  5. Are your listed product codes the ones FDA uses in its product classification database, or the ones you guessed from similar devices?
  6. Does each listed device have a valid 510(k), De Novo, PMA, or exemption basis?
  7. Is your registration renewal a line item in your annual budget and your management review agenda?
  8. If FDA sent a warning letter to your US Agent tomorrow, would you know within 48 hours?

Frequently Asked Questions

Do I need to register before I have 510(k) clearance? No — and usually you should not. Establishment registration without a cleared device simply means you are paying an annual fee to tell FDA you exist. Register when your commercial launch is within a few months.

Can my EU authorized representative act as US Agent? No. The US Agent must have a physical address in the United States. Your EU authorized representative under MDR Article 11 is a different legal role for a different jurisdiction.

What happens if I miss the annual renewal? Your registration lapses. Devices from that establishment cannot lawfully be imported into the US until you re-register and pay. FDA does not typically fine you for a lapse; the commercial consequence — blocked shipments — is the real penalty.

Is the establishment registration fee refundable? No. Once paid, it is not refundable. Budget it as a fixed annual cost.

Do contract manufacturers need to register separately? Yes. Each establishment in the chain that manufactures, processes, packages, or labels the device for the US market must register and list, including foreign contract manufacturers. This is separate from your MDR supplier controls.

Does registration trigger an FDA inspection? Registration by itself does not trigger an inspection, but it places you in the inspection pool. For Class II and Class III devices, foreign inspections are conducted on a risk-based cadence.

How does this relate to UDI? UDI requirements under 21 CFR Part 801 are separate from establishment registration but linked operationally. The UDI data is submitted to FDA's GUDID database, not FURLS. Both must be current.

Sources

  1. Federal Food, Drug, and Cosmetic Act Section 510. 21 CFR Part 807 Subparts B and D .
  2. FDA FURLS / Device Registration and Listing Module (DRLM) guidance.
  3. Medical Device User Fee Amendments (MDUFA) annual fee schedule .
  4. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 29, Article 31.
  5. 21 CFR Part 801 (Labeling) — UDI requirements .