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:
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 $9,280. 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 $7,653 and it jumped to $9,280 in FY2025, and is set to $11,423 for FY2026. These hikes reflect FDA’s budget needs and inflation adjustments.
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.
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).
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.
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.
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.
