Annual FDA Establishment Registration Fee & Renewal Requirements

Annual FDA Medical Device Establishment Registration – Understand the yearly user fee, renewal process, deadlines, and best practices to keep your facility compliant, maintain active registration, and avoid enforcement or import/export issues.

Once you’ve registered your device establishment, maintaining that status is an ongoing obligation. FDA operates on an annual renewal cycle for registrations, and there is a user fee associated with keeping your registration active each year. Failing to pay the fee or renew your registration can quickly put you out of compliance. Let’s break down the key renewal requirements:

Annual Registration User Fee

FDA’s medical device program is partly funded by user fees under the Medical Device User Fee Amendments (MDUFA). Each year, every registered establishment must pay an Annual Establishment Registration Fee to FDA. The amount is substantial and adjusted annually. For Fiscal Year 2025 (which runs from Oct 1, 2024 through Sep 30, 2025), the establishment registration fee is the current annual fee (see FDA's user fee page). This is a flat fee – unlike some other FDA fees, there are no small business discounts or waivers for the registration fee in FY2025. (Beginning in FY2026, FDA will allow certain small businesses to request a waiver in cases of financial hardship, but that does not apply for the initial years of MDUFA V). The fee typically increases each year; for perspective, FY2024’s fee was the current annual fee (see FDA's user fee page) and it jumped to the current annual fee (see FDA's user fee page) in FY2025, and is set to the current annual fee (see FDA's user fee page) for FY2026. These hikes reflect FDA’s budget needs and inflation adjustments.

Payment Timeline

The user fee must be paid before you renew your registration each year. FDA’s schedule for annual registration renewal is October 1 to December 31 each calendar year. This window corresponds to the start of FDA’s fiscal year. By December 31, you must have paid the fee and submitted your annual registration update, or your registration will lapse. FDA sends reminder emails to the official correspondent on record (so keep that contact info updated). It’s wise to mark your calendar for October each year to initiate the process, rather than risking a last-minute rush during the holidays. Remember, as mentioned earlier, fee payment confirmation can take a few days, so paying in October or November is preferable to ensure you can complete the online renewal by the deadline.

Annual Renewal Process

What does “renewing” involve? Even though we often say “pay the fee,” you actually need to both pay the fee and go into FURLS to re-confirm or update your registration information. Specifically, FDA requires that registration information be submitted (or verified/updated) between Oct 1 and Dec 31 each year, even if no changes occurred. In practice, once your fee is paid, you log into FURLS, choose the Annual Registration option, and essentially re-submit your facility registration for the new fiscal year. The system will prompt you to review your current listing info and make any necessary updates at that time. If nothing has changed (no new devices, same address, etc.), you still must click through and confirm the registration. Upon completion, the new year’s registration is active, and you’ll get a confirmation (often the same registration number continues, but now marked for the new FY).

What If You Don’t Renew?

Failing to renew by December 31 has serious consequences. As of January 1, FDA’s database will mark non-renewed establishments as inactive (not registered for the current year). Legally, at that point any devices from that establishment are misbranded due to non-registration. FDA can refuse imports of devices from a facility that didn’t renew on time – in fact, this happens regularly. For example, FDA has an Import Alert (99-34) that targets any medical devices from firms who are not properly registered/listed, detaining them without physical exam. Distributors and import brokers also check FDA’s database, and if they see your registration is expired, it will halt shipments. Additionally, FDA will not accept new 510(k) submissions or PMA applications from a company that hasn’t paid its annual registration fee – the submission would be put on hold until the fee is paid (since proof of fee payment is required in submissions). Essentially, business can grind to a halt.

FDA typically does not send a formal warning letter immediately for a missed registration, but they don’t need to – the consequences (shipments refused, etc.) are incentive enough. If a significant time lapses, FDA could issue a warning letter citing the firm for failure to register (as misbranding) and threaten further enforcement. But most companies catch the issue quickly when their operations are impacted. The cost of missing a renewal can far exceed the fee itself – lost sales from a detained shipment, for instance, or delays in market entry for a new product.

Renewal Best Practices

• Start Early: Begin the renewal process each year in early Q4 (October). This gives time to resolve any payment issues or account access problems. - Budget for the Fee: Include the registration fee in your annual budgeting, as it is a known recurring cost (and note it often increases year-to-year). The fee must be paid through FDA’s user fee website; ensure your finance team is prepared for the amount. There are no discounts, so plan for the full fee.
• Verify Updates: Use the renewal as an opportunity to double-check your listing info. Did you introduce any new device models this year that need to be listed? Did your company name or address change? Any new contract manufacturers or sterilizers involved? You are required to update such changes at the time of annual registration if you haven’t already.
• Keep Proof: After renewing, save the confirmation email or screenshot. It’s rare, but if any question arises (e.g., a customer or distributor wants proof of current registration), you’ll have it handy. Also, the FDA Registration & Listing database online will reflect an “Active” status for the current year for your establishment – that’s public proof of compliance.

One more note on fees: The establishment fee is separate from any premarket submission fees. Even if you paid a 510(k) fee, you still owe the establishment fee annually. Conversely, paying the establishment fee doesn’t cover any application fees if you need to submit new device clearances – they are distinct.

Renewal for Foreign vs. Domestic

The process and fee are the same for foreign and domestic firms. Foreign establishments must also ensure their U.S. Agent information is up-to-date at renewal, since FDA will send them notifications if a foreign firm fails to register. There are no exemptions – even if you only export devices and don’t sell in the U.S., if you’re registered with FDA you must pay the fee yearly (unless you formally deregister your establishment, which you’d only do if you stopped marketing in the U.S. entirely).

In summary, annual renewal is a non-negotiable part of FDA device regulation. Mark your calendar, pay the fee, and keep your registration active. It’s an easy task to complete on time, but a painful one to fix if forgotten. In the next sections, we will explore device listing details and how to handle changes or updates to your registration outside the annual cycle.

The Clock Is Ticking: FDA Annual Registration Is Not Optional

Every year, between October 1 and December 31, medical device establishments registered with the FDA must renew their registration for the following fiscal year. This is not a formality. Under 21 CFR Part 807, failure to renew your establishment registration on time renders your facility legally unregistered — and operating an unregistered establishment is a prohibited act under Section 301(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). For startups and small-to-mid-sized device companies, the downstream consequences can be severe and, frankly, avoidable.

This post breaks down exactly what you need to do, when you need to do it, how much it costs, and what happens if the deadline slips through the cracks.

Who Is Required to Register and List?

If your establishment is involved in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use and distributed in the United States, you are required to register under 21 CFR 807.20. This includes domestic and foreign establishments. Device listing — identifying which devices your establishment makes — is a companion requirement under 21 CFR 807.25 and must be kept current as well.

Exemptions exist but are narrow. Certain component manufacturers, licensed practitioners, and specific distributor types may qualify. If you are unsure whether your establishment qualifies for an exemption, do not assume — confirm with a qualified regulatory consultant before you skip the process.

The October 1 to December 31 Renewal Window: What Actually Happens

The FDA fiscal year runs from October 1 through September 30. Establishments must renew their registration each year during the October 1 to December 31 window via the FDA Unified Registration and Listing System (FURLS), accessed through the FDA Industry Systems portal.

During renewal, you are required to:

• Confirm or update establishment information, including owner/operator details and U.S. agent information for foreign facilities
• Review and update your device listings — adding new devices, modifying existing entries, or removing discontinued products
• Pay the annual establishment registration user fee, which is mandated under Section 738(a)(3) of the FD&C Act and set annually by the FDA

The registration fee is set annually and published in the current annual fee (see FDA's user fee page) in the Federal Register, typically in August or September, and can change year over year based on statutory adjustments. Small businesses that meet the FDA's definition under 21 CFR 807.3(r) may qualify for a reduced fee — but that qualification must be affirmatively established and is not automatically applied.

What Happens If You Miss the December 31 Deadline?

This is where many companies underestimate the risk. If your establishment registration lapses, the legal and operational consequences are real and immediate.

1. Your Establishment Becomes Unregistered

FDA's registration database is publicly searchable. Distributors, hospital systems, group purchasing organizations, and international regulatory bodies routinely verify supplier registration status. An unregistered status can trigger contract holds, purchase order cancellations, and failed supplier qualification audits — all of which hit revenue directly.

2. Shipment Detention and Import Alerts

For foreign establishments, failure to register or renew can result in devices being detained at the U.S. border. FDA has authority under Section 801(a) of the FD&C Act to refuse admission to devices from unregistered foreign facilities. Even one detained shipment can disrupt your entire U.S. commercial operation.

3. Warning Letters and Enforcement Action

FDA can — and does — issue Warning Letters citing failure to register or maintain current registration as a violation. A Warning Letter is public, indexed on FDA's website, and can affect investor confidence, M&A due diligence, and existing distributor relationships. In more serious scenarios, failure to register can be cited as part of a broader enforcement action.

4. Disruption to 510(k) and PMA Submissions

If you have a pending 510(k) or PMA application, an unregistered establishment can complicate or delay FDA review. FDA reviewers cross-reference establishment registration status during premarket review.

Practical Steps to Stay Ahead of the Deadline

• Set a calendar reminder for October 1 — do not wait until late December
• Confirm your FURLS account credentials are current and that the right personnel have access well before October
• Review your device listings now — renewal is an ideal time to clean up discontinued products or add recently cleared devices
• Verify your fee amount in the Federal Register notice published that August or September
• For foreign establishments, confirm your U.S. agent designation is current under 21 CFR 807.40
• Document your renewal confirmation number and retain it as part of your quality records

A Note on Device Listing Accuracy

Annual registration renewal is also your annual checkpoint for device listing accuracy. Under 21 CFR 807.30, establishments must update device listings within 30 days of a change. In practice, many companies accumulate discrepancies over time. Use the renewal window to reconcile your listed devices against your actual product portfolio. Inaccurate listings are an FDA inspection finding waiting to happen.

Do Not Treat This as Administrative Noise

FDA annual registration renewal is one of the most straightforward compliance requirements in device regulation — but it carries disproportionate risk when neglected. For companies in growth mode, juggling product development, clinical work, and commercial scale-up, it is exactly the type of recurring deadline that falls through the cracks without a systematic process in place.

At ADB Consulting and CRO Inc., we help medical device companies build the regulatory infrastructure to stay ahead of requirements like this — not react to them after the damage is done. Whether you need support managing your annual registration, preparing for an FDA inspection, or navigating a premarket submission, our team is ready to help.

Book a free discovery call with Andre Butler at adbccro.com and find out how ADB Consulting and CRO Inc. can keep your regulatory program on track — before a missed deadline becomes a crisis.

If this applies to your program, our Device Registration service walks through the process in detail.

FDA Annual Registration Renewal: What Every Device Company Needs to Know Before October 1

Every year, without exception, FDA-registered medical device establishments must renew their registration during a single, fixed window: October 1 through December 31. Miss it, and you are not simply late on paperwork. You are operating an unregistered establishment, which carries real regulatory and commercial consequences. If you are a startup founder preparing for your first renewal, or a VP of Regulatory Affairs managing multiple sites, this post breaks down exactly what is required, what it costs, and what happens when companies fall through the cracks.

The Regulatory Foundation: 21 CFR Part 807

The requirement to register with FDA is codified under 21 CFR Part 807, Subpart B. Under 21 CFR 807.21, domestic device establishments must register annually. Foreign establishments distributing devices into the United States carry the same obligation under 21 CFR 807.40. The Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 510, is the statutory authority underlying all of this — which is why device establishment registration is often called a '510 registration,' entirely distinct from a 510(k) premarket clearance.

FDA operationalizes annual renewal through its Unified Registration and Listing System (FURLS), accessed via the FDA Industry Systems portal. Renewals completed outside the October 1 to December 31 window are not accepted for the current fiscal year cycle. There is no grace period and no formal extension mechanism.

The Annual User Fee: What You Owe and When

Annual registration is not free. FDA assesses a Medical Device Establishment Registration User Fee authorized under Section 738 of the FD&C Act. The fee is recalculated each fiscal year — FDA publishes the current annual fee (see FDA's user fee page) in the Federal Register each year, typically in late summer ahead of the October 1 renewal opening.

Key fee facts every registrant should know:

• Payment is required before registration is considered complete. Submitting your renewal in FURLS without paying the fee does not constitute valid registration.
• Small businesses may qualify for a reduced fee. Under 21 CFR 807 and the Small Business Regulatory Relief provisions, establishments that meet FDA's definition of a small business — generally less than $100 million in gross receipts — may pay a reduced rate; see the current small business fee (see FDA's user fee page). You must pre-qualify through FDA's Center for Devices and Radiological Health (CDRH) and receive a Small Business Determination before submitting payment at the reduced rate.
• Fee waivers are available in limited circumstances, including for certain foreign governments and nonprofit entities, but these are narrow exceptions, not the norm.
• Device listing (21 CFR Part 807, Subpart D) is linked to registration and must also be current. Listing itself carries no separate user fee, but an invalid registration invalidates your listing status.

What Actually Happens If You Miss the Window

This is where founders and regulatory teams sometimes underestimate the stakes. FDA does not send a warning letter the moment your registration lapses — but the downstream consequences are immediate and compounding.

Your establishment becomes unregistered. Under 21 CFR 807.20, operating a device establishment without a valid registration is a prohibited act under Section 301(p) of the FD&C Act. FDA can initiate regulatory action including Warning Letters, import alerts for foreign establishments, and in serious cases, injunctive action.

Import and distribution disruptions are real. If you are a foreign establishment and your registration lapses, FDA's Operational and Administrative System for Import Support (OASIS) will flag your shipments. Products can be detained at the border — a business-stopping event if you are mid-launch or scaling a commercial line.

Contract and procurement consequences. Many hospital systems, group purchasing organizations (GPOs), and distributors require current FDA registration as a contractual condition. A lapsed registration discovered during a supplier audit can cost you the contract.

Inspection readiness is impacted. If FDA selects your establishment for a routine inspection under 21 CFR Part 820 and your registration is not current, that discrepancy will be documented. It signals to the investigator that your quality system may have broader compliance gaps.

Practical Steps to Stay Ahead of the October 1 Deadline

The renewal window opens October 1 — not October 15, not 'sometime in Q4.' Build these actions into your regulatory calendar now:

• Verify your FURLS account access in September. Account lockouts and forgotten credentials are a surprisingly common reason companies miss the window. Confirm your FDA Industry Systems login is active and that the right team members have account access.
• Confirm your Small Business Determination status. If you qualified for a reduced fee last year, that determination does not automatically roll over. Reapply early if your financials still qualify.
• Audit your device listings before renewal. Annual registration is your opportunity to helps prepare all listed devices are accurate and current under 21 CFR 807.26. Discontinued devices should be delisted; new devices added post-clearance must appear.
• Budget the fee in Q3. Finance teams that are not familiar with FDA user fees sometimes flag the registration payment as unexpected. Get it into the budget cycle before it becomes an accounts-payable scramble in November.
• Set calendar reminders for October 1 and December 1. The December 1 reminder gives you four weeks of runway to resolve any payment or system issues before the December 31 hard close.

The Bottom Line

FDA annual registration renewal is one of the most administratively straightforward compliance obligations device companies face — but it is also one of the most commonly fumbled, especially at early-stage companies where regulatory bandwidth is stretched thin. The October 1 to December 31 window is fixed, the fees are non-negotiable, and the consequences of lapsing are immediate. Treat this deadline with the same urgency you give your 510(k) submission or your ISO 13485 surveillance audit.

At ADB Consulting and CRO Inc., we work with medical device startups and established manufacturers to keep their regulatory programs current, audit-ready, and commercially uninterrupted. Whether you need support managing your annual registration, conducting a listing audit, or navigating a lapsed registration situation, our team is here to help you stay compliant and move forward with confidence.

Ready to make sure your registration is handled correctly this cycle? Book a free discovery call with Andre Butler and the ADB Consulting team at adbccro.com today.

Related reading: our FDA establishment registration and listing service covers this in more depth.

FDA Annual Establishment Registration Renewal: What Every Device Company Needs to Know Before December 31

Every year, medical device companies face a hard regulatory deadline that carries real operational consequences if missed: the annual renewal of FDA establishment registration. The renewal window opens October 1 and closes December 31. That is a 92-day window — and it moves fast, especially for lean teams juggling product launches, audits, and year-end planning.

This post breaks down exactly what is required, what it costs, and what happens to your business if you let the deadline slip.

The Legal Basis: Why Registration Is Not Optional

Under 21 CFR Part 807, domestic and foreign establishments that manufacture, prepare, propagate, compound, or process medical devices intended for U.S. commercial distribution are required to register with FDA and list their devices. This requirement applies to manufacturers, contract manufacturers, specification developers, repackagers, relabelers, and certain initial importers.

The statutory authority sits in Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA reinforced and modernized the process through the Medical Device User Fee Amendments (MDUFA) framework, which tied annual registration to user fee payment — meaning registration and fee submission are now inseparable.

There is no grace period. There is no extension mechanism built into the regulation. The window is October 1 through December 31, full stop.

How the Registration and Fee Process Works

Registration and device listing are completed through FDA's Unified Registration and Listing System (FURLS), accessed via the FDA Industry Systems portal. Here is the sequence every responsible regulatory team should follow:

• Confirm your FEI number is active — Your Facility Establishment Identifier (FEI) must be in good standing before you can submit renewal.
• Pay the annual establishment registration fee — see the current annual fee (see FDA's user fee page) per establishment. Small businesses that qualify under FDA's definition (fewer than 500 employees and gross receipts or sales of $100 million or less) may be eligible for reduced fees — historically set at 50% of the standard rate. Always confirm the current year fee on FDA's official MDUFA fee schedule page, as amounts adjust annually.
• Submit or confirm your device listing — Registration renewal does not automatically update your device listings. Under 21 CFR 807.20, listings must be updated within 30 days of any change in marketed devices. Use the renewal window as an opportunity to audit your listed devices against your actual portfolio.
• Receive and retain your registration confirmation — Print or archive the updated registration certificate. Customers, distributors, and notified bodies will ask for it.

What Happens If You Miss the December 31 Deadline

This is where the stakes become operationally significant. Under 21 CFR 807.22, an establishment that fails to register or pay the required fee is considered to be operating in violation of the FD&C Act. The practical consequences cascade quickly:

• Your devices become adulterated under 21 CFR 807.87 — Devices from an unregistered establishment are legally considered adulterated, making their distribution a prohibited act under Section 301 of the FD&C Act.
• Import alerts for foreign establishments — FDA can place foreign establishments on import alert, resulting in automatic detention of shipments at the U.S. border — with no case-by-case review.
• Domestic distribution holds — While FDA does not station inspectors at shipping docks, the compliance risk is real. During any subsequent inspection or audit, lapsed registration is an immediate red flag and likely Form 483 observation territory.
• Customer and distributor contracts at risk — GPO agreements, hospital supply contracts, and distribution agreements routinely require current FDA registration as a condition of doing business. A lapsed registration can trigger breach of contract provisions.
• 510(k) and PMA submissions impacted — FDA reviewers verify establishment registration status during premarket submission review. A lapsed registration can result in a hold or refuse-to-accept action on pending submissions.

Common Mistakes That Cause Missed Renewals

In our consulting practice, we see the same patterns repeatedly. Registration is assigned to a single person who leaves the company with no documented handoff. The FURLS account credentials are lost or tied to a former employee email. Finance and regulatory teams operate in silos, causing fee payment to fall through the cracks. Foreign parent companies assume a U.S. subsidiary is handling it — and vice versa.

The fix is not complicated, but it requires intentional process ownership. Build the October 1 renewal window into your regulatory calendar as a first-priority event, not an administrative afterthought.

A Practical Pre-Renewal Checklist

• Confirm FURLS account access and update login credentials in a secure shared system
• Identify all FEI numbers associated with your establishment(s)
• Pull the current fiscal year fee schedule from FDA.gov and get finance approval in September
• Audit your device listings for accuracy before submitting renewal
• Document renewal completion and retain confirmation records for at least two years
• Calendar a 30-day pre-deadline reminder for October 1 each year

Do Not Let a Procedural Deadline Create a Regulatory Crisis

FDA establishment registration renewal is one of the most straightforward compliance requirements in the device regulatory framework — but it is also one of the most consequential to miss. For startups managing their first commercial launch and mid-size companies with multiple product lines and facilities, the operational risk of a lapsed registration is disproportionate to the effort required to stay current.

At ADB Consulting & CRO Inc., we help medical device companies build regulatory systems that do not depend on institutional memory or heroics. Whether you need a registration audit, help recovering a lapsed registration, or a full regulatory calendar built for your organization, we are here to help you stay ahead of the deadlines that matter.

Book a free discovery call with Andre Butler and the ADB Consulting team at adbccro.com. Let us make sure your registration is locked in before December 31 — and that your regulatory foundation is built to scale.

If this applies to your program, our Device Registration service walks through the process in detail.

Frequently Asked Questions

Annual Registration User Fee?

FDA’s medical device program is partly funded by user fees under the Medical Device User Fee Amendments (MDUFA). Each year, every registered establishment must pay an Annual Establishment Registration Fee to FDA. The amount is substantial and adjusted annually. For Fiscal Year 2025 (which runs fr...

Payment Timeline?

The user fee must be paid before you renew your registration each year. FDA’s schedule for annual registration renewal is October 1 to December 31 each calendar year. This window corresponds to the start of FDA’s fiscal year. By December 31, you must have paid the fee and submitted your annual re...

Annual Renewal Process?

What does “renewing” involve? Even though we often say “pay the fee,” you actually need to both pay the fee and go into FURLS to re-confirm or update your registration information. Specifically, FDA requires that registration information be submitted (or verified/updated) between Oct 1 and Dec 31...

What If You Don’t Renew?

Failing to renew by December 31 has serious consequences. As of January 1, FDA’s database will mark non-renewed establishments as inactive (not registered for the current year). Legally, at that point any devices from that establishment are misbranded due to non-registration. FDA can refuse impor...