FDA FY2027 Device Establishment Registration: A Canadian Exporter's Checklist

For Canadian medical device companies that sell into the United States, the last quarter of the year carries a quiet but hard deadline. Between 1 October and 31 December, every establishment that makes or imports devices for the US market has to renew its FDA registration, confirm its device listings, and pay the annual establishment registration fee. For fiscal year 2027 that fee is $13,785, and unlike most FDA device fees there is no small-business discount on it.

Miss the window or skip the payment, and the registration lapses. A lapsed registration is not a paperwork problem you can quietly fix in January. It can make your devices misbranded under United States law and give FDA grounds to refuse them at the border. This guide explains who must register, what the FY2027 fee covers, how the United States agent rule works for Canadian firms, and the steps to renew cleanly before the year ends.

Executive summary

FDA requires every medical device establishment, including foreign manufacturers and the United States importers who bring their devices in, to register and list devices each year. The annual renewal window runs from 1 October to 31 December for the coming fiscal year, under 21 CFR Part 807. The FY2027 annual establishment registration fee is $13,785, set by the Medical Device User Fee Amendments and published in the Federal Register. Foreign establishments must also name a United States agent. A device whose establishment is not registered, or that is not listed, can be treated as misbranded and refused entry to the United States.

What the FY2027 registration renewal is

What it is. FDA establishment registration is the annual process by which a device establishment tells FDA who it is, where it operates, and what devices it handles. Device listing is the companion step that identifies each device in commercial distribution. Why it matters. Registration and listing are what let your devices lawfully enter and stay in the United States market. What to do. Renew both during the 1 October to 31 December window and pay the establishment registration fee. How it affects compliance. FDA uses the registration database to plan inspections and to screen imports, so an accurate, current registration is the backbone of your United States market access.

Registration is handled electronically through FDA's Unified Registration and Listing System. Fiscal year 2027 runs from 1 October 2026 to 30 September 2027, so the renewal you complete this autumn covers that year. This is separate from any 510(k) clearance or PMA approval you already hold. Clearance lets a device onto the market once. Registration and listing keep the establishment and its devices in good standing every year. For the Canadian side of your device obligations, see our guide to what Health Canada expects in a Class III or IV medical device licence application.

Who must register, and the United States agent rule

In short. Both the foreign manufacturer and the United States parties in the supply chain have registration duties, and a foreign establishment cannot register without naming a United States agent.

Canadian companies often assume their United States distributor handles everything. That is a costly assumption. The foreign manufacturer has its own registration and listing obligation, and the roles do not transfer. The table below shows who does what.

Under 21 CFR 807.40, a foreign establishment must submit the name, address and phone number of its United States agent as part of its registration. The agent assists FDA with communications, answers questions about the firm's imported products, and helps schedule inspections. The agent is not the same as an initial importer, although one company can sometimes fill both roles. If you also need to understand how small-business status can cut your other FDA fees, read our article on the FDA small business discount and the CRA certification Canadian device firms miss.

The FY2027 fee, and why there is no small-business break

What it is. A mandatory annual fee that every registered establishment pays to keep its registration active. Why it matters. It is one of the few FDA device fees with no reduced rate for small businesses, so a small Canadian manufacturer pays the same amount as a large one. What to do. Budget the full fee per establishment and pay it before you complete registration.

The establishment registration fee is set each year under section 738 of the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee Amendments of 2022, and published in a Federal Register notice. For FY2027 the fee rose to $13,785. The 510(k) submission fee does have a small-business rate for firms that qualify, but the establishment registration fee does not. Registration is not complete until the fee is paid, so plan the payment early in the window rather than on 31 December.

The 1 October to 31 December renewal window

What it is. Under 21 CFR 807.22, annual registration takes place during the period beginning 1 October and ending 31 December of each fiscal year. Why it matters. The window is fixed and short, and it overlaps a busy holiday period. What to do. Start early, confirm your account access, and do not leave the payment to the final week.

During the window you confirm that your establishment information is correct, verify or update your device listings, and pay the fee. Even if nothing has changed, you still have to complete the annual renewal. An establishment that does not renew by 31 December is no longer registered for the new fiscal year. Canadian firms that rely on a United States agent or a third party to file should confirm, in writing and in advance, who is completing each step and by what date.

Device listing is a separate obligation

What it is. Under 21 CFR 807.20, the owner or operator must list every device in commercial distribution. Why it matters. Registration without accurate listing is incomplete, and an unlisted device can be treated the same as an unregistered one.

Listing identifies each device, its product code, and the activities performed on it. Review your listings during the renewal to remove devices you no longer distribute and to add any new ones. Keep the listing consistent with your 510(k) clearances, your labelling, and the way the device is actually marketed. Inconsistencies between what you listed and what FDA sees in the market are a common trigger for questions and import holds.

What happens if you do not register or pay

What it is. A device from an establishment that is not registered, or a device that is not listed, can be considered misbranded under the Federal Food, Drug, and Cosmetic Act. Why it matters. Misbranded devices can be detained and refused admission to the United States. What to do. Treat registration and the fee payment as a shipping prerequisite, not an afterthought.

For a Canadian exporter, the practical consequence is at the border. FDA screens imports against the registration and listing database. If your establishment shows as unregistered for the current fiscal year, a shipment can be held and refused, which disrupts customers, contracts and cash flow. Reinstating registration mid-year is possible, but it still requires paying the annual fee, and the lost time cannot be recovered. This is why a lapsed registration is far more expensive than the fee that would have prevented it.

How registration connects to inspections and import screening

What it is. The registration database is not a filing cabinet. FDA uses it to plan inspections and to screen every device import at entry. Why it matters. Errors in your registration surface as inspection questions and border holds, not as a quiet correction. What to do. Keep the establishment, agent and listing data accurate all year, not only at renewal.

A Canadian manufacturer that updates a device but never updates its listing, or that moves facilities without changing the registered address, creates a mismatch FDA can see. At entry, the importer's filing is screened against the registration and listing records. When the device code, the manufacturer, or the registration status does not match, the shipment can be held pending clarification. In an inspection, the same mismatches read as a quality-system weakness, because they show the firm is not controlling its own regulatory records.

A simple example shows the cost. A small Ontario manufacturer clears a Class II device, appoints a United States agent, and ships for two years without issue. The agent changes email providers and the renewal reminder never arrives. On 2 January the next shipment is held at the border because the establishment shows as unregistered for the new fiscal year. The fix is to pay the full $13,785 fee and complete the renewal, but the held shipment, the customer escalation and the rush all landed because one reminder was missed. The corrective action is not complicated, a monitored renewal calendar and a confirmed agent contact, but it has to exist before the deadline, not after the hold.

How to renew in five steps

1. Confirm account access. Make sure someone can log in to FDA's registration and listing system before 1 October, and reset credentials early if needed.
2. Verify establishment and agent details. Check the establishment information and confirm your United States agent is current and willing to continue.
3. Review device listings. Update listings, remove discontinued devices, and confirm product codes and activities.
4. Pay the establishment registration fee. Pay the $13,785 FY2027 fee and keep the payment confirmation, because registration is not complete until it is paid.
5. Complete renewal before 31 December. Submit the renewal, confirm the registration shows active for FY2027, and save the record.

FDA registration renewal compliance checklist

• Confirmed who owns the 1 October to 31 December renewal and a backup.
• Verified login access to FDA's registration and listing system before the window opens.
• Confirmed the United States agent is current, reachable, and agrees to continue.
• Reviewed and updated all device listings and product codes.
• Removed devices no longer in commercial distribution.
• Budgeted the $13,785 FY2027 establishment registration fee per establishment.
• Paid the fee and saved the payment confirmation.
• Completed the renewal and confirmed active status for FY2027 before 31 December.
• Aligned listings with current 510(k) clearances and labelling.
• Recorded the renewal and set a reminder for next year's window.

Common mistakes to avoid

Assuming the United States distributor registers for you. The foreign manufacturer has its own registration and listing duty. It does not pass to a distributor.

Treating listing as optional. Registration and listing are separate. An unlisted device can be treated like an unregistered one.

Leaving the fee to the last week. Registration is not complete until the fee is paid, and year-end payment and system delays can push you past 31 December.

Letting the United States agent lapse. If your agent has changed or will not continue, you cannot complete registration until a new agent is named.

Expecting a small-business discount on registration. The establishment registration fee has no reduced rate. Only certain other fees, such as the 510(k), do.

How MFLRC can help

MFLRC helps Canadian device manufacturers keep their United States market access clean and uninterrupted. We can act as or coordinate your United States agent, manage the annual registration and listing renewal, reconcile your listings with your clearances, and build a user-fee and renewal calendar that covers both your FDA and your Health Canada deadlines in one view.

We also support new and amended submissions, inspection readiness, and cross-border strategy through our regulatory affairs, licensing and import and export services and our audits and gap assessments. Explore our full medical devices regulatory services to see how we keep Canadian exporters compliant on both sides of the border.

Registration season is open and you want it handled right? Contact MFLRC for FDA registration, listing and United States agent support.

Frequently asked questions

Do I need to renew my FDA establishment registration every year?

Yes. Under 21 CFR 807.22, registration must be renewed annually between 1 October and 31 December for the coming fiscal year, and the annual establishment registration fee must be paid. Renewal is required even if none of your information has changed.

How much is the FDA device establishment registration fee for FY2027?

The FY2027 annual establishment registration fee is $13,785, set under the Medical Device User Fee Amendments and published in the Federal Register. There is no small-business reduction for this fee, so every registered establishment pays the same amount.

Does a Canadian manufacturer need a United States agent?

Yes. Under 21 CFR 807.40, a foreign establishment must name a United States agent as part of its registration. The agent is a United States contact who assists FDA with communications, answers questions about imported products, and helps schedule inspections.

Is device listing the same as registration?

No. Registration identifies the establishment. Listing, under 21 CFR 807.20, identifies each device in commercial distribution. Both are required, and an unlisted device can be treated like an unregistered one.

What happens if my FDA registration lapses?

A device from an unregistered establishment, or an unlisted device, can be considered misbranded under the Federal Food, Drug, and Cosmetic Act and refused admission to the United States. Reinstating mid-year still requires paying the full annual fee, so a lapse is costly and disruptive.

Does my FDA clearance or 510(k) cover registration?

No. A 510(k) clearance or PMA approval lets a device onto the market, but registration and listing are separate annual obligations that keep the establishment and its devices in good standing. You need both.

Sources and references

• Federal Register, Medical Device User Fee Rates for Fiscal Year 2027 (30 July 2026)
• 21 CFR Part 807, Establishment Registration and Device Listing, eCFR
• FDA, Device Registration and Listing
• FDA, Medical Device User Fee Amendments (MDUFA): Fees