What is an FDA Establishment Registration & Listing Requirement?
Every manufacturer, both foreign and domestic, that makes or distributes medical devices or IVDs in the US must register its facility, called an “establishment,” with the US FDA within 30 days of beginning device distribution and before importing products to the US. The registration must be renewed annually for as long as your device is available on the US market.
The Establishment Listing is your company’s consent to FDA oversight, which includes routine inspections and post-market reporting duties (i.e., Medical Device Reporting (MDR) and post market surveillance). As you obtain regulatory authorizations from FDA for specific devices, you must add Device Listings to your Establishment Registration.
The role of the Official Correspondent
The Official Correspondent is the individual or entity that maintains the FURLS account, certifies the accuracy of establishment and device-listing information, pays the annual user fee, and remains FDA’s first stop for routine administrative matters such as inspection scheduling, post-market queries, deficiency letters, or renewal reminders. For foreign manufacturers, FDA also requires an US Agent, which is a separate role that must have a permanent US-based operation and be available by phone to receive FDA communications.
Every manufacturer must list an Official Correspondent in its Establishment Registration, while foreign manufacturers must list the Official Correspondent and the US Agent. The FDA will not accept or renew the registration until each contact is complete. A foreign firm may appoint the same organization to serve as Official Correspondent and US Agent, if the individual or entity is US-based. Changes to the US Agent and/or Official Correspondent must be updated within 30 days.
How to Register your Medical Device Establishment with the US FDA
Establishment Registrations are submitted through FDA’s Device Registration & Listing Module (DRLM) inside the FURLS portal. Here’s an overview of the registration process:
- Pay the annual establishment user fee.
The establishment registration fee ($9,280 for 2025) must be paid via the Device Facility User Fee website. The PIN number generated when the payment is completed must be entered into FURLS with your establishment registration submission. You cannot complete the submission without the payment confirmation, so it is important to complete this step first.
- Create or update your existing FURLS account.
FURLS distinguishes between owner/operator accounts and official correspondent accounts, which are assigned by the owner/operator to manage the annual establishment registration. Owner/operators can create, modify, or cancel any record they originate, while official correspondents can create or update only the registrations and listings delegated to them.
- Submit establishment information electronically.
Key data include legal entity name, physical address, D-U-N-S® number (the Unique Facility Identifier (UFI), which must match your company’s entry in Dun & Bradstreet), and device‐related activities (e.g., manufacturer, specification developer, re-labeler, etc.).
- Complete your submission.
Owner/operator or Official Correspondent certifies that all information is true and complete; enters payment confirmation PIN.
- Maintain the registration.
Updates are mandatory within 30 days of any change (name, address, ownership, activities), and annual renewal must be completed between 1 October and 31 December to avoid automatic invalidation, which could disrupt the importation of your device.
After the FDA accepts your first establishment-registration submission, it generates a unique seven-digit Facility Establishment Identifier (FEI). The FEI is FDA’s internal tracking number for inspections, user-fee billing, and enforcement records, such as a Form FDA 482 (Notice of Inspection).
What Is FDA Device Listing?
While establishment registration tells FDA who you are, device listing tells FDA what you place on the US market. Each distinct device or IVD family must be listed under the correct:
- Proprietary (brand) name(s)
- Regulation number and product code
- 510(k), De Novo, PMA, or exemption status
- Unique Device Identifier (UDI) information for Class II and III products
After a listing is accepted, the FDA issues a listing number that links the product to its legal manufacturer. Listing records must be updated whenever a device is added, discontinued, or significantly modified, and no later than the next annual renewal cycle.
