Learn how to register your medical device establishment with the FDA. Follow step-by-step guidance on fee payment, FURLS account setup, facility info, device listing, submission, and post-registration actions to ensure compliance.
Registering your establishment with the FDA may sound daunting, but the process can be broken down into clear steps. The FDA’s Device Registration and Listing Module (DRLM) – part of the FDA Unified Registration and Listing System (FURLS) – is the online portal where all registration and listing information is submitted. Below is a step-by-step guide to completing an initial medical device establishment registration:
Before you can register, you must pay the yearly establishment registration fee. This fee is required by law (no exceptions, even for small businesses), and it must be paid each fiscal year prior to registration. Payment is made on the FDA’s Device Facility User Fee (DFUF) website. When you pay, you will receive a Payment Identification Number (PIN) and a Payment Confirmation Number (PCN). Save these numbers – you will need to input them during the registration submission to prove the fee was paid. Tip: The payment can take a couple of days to clear in FDA’s system, so don’t wait until the last minute. It’s wise to pay the fee a few days (or weeks) before you plan to register, especially toward the busy end-of-year period.
Next, go to FDA’s FURLS portal (access.fda.gov) and either log in or create an account for your organization. The Owner/Operator of the establishment should be the primary account holder. If your company has never registered any device establishment before, you’ll choose the option to create a new account for a new owner/operator. You’ll provide basic information like the company name, address, and contact details. You may also designate an Official Correspondent – the person responsible for maintaining the registration – in this step. (For foreign firms, you will also need to designate a U.S. Agent during the process, but we’ll address that in another section.)
Each owner/operator gets a unique identifier (Owner/Operator number) in FDA’s system once you start the registration. Important: If your company already has a FURLS account (for example, from a prior year or for another facility), do not create a new one. Always use your existing account to avoid confusion or duplicate records. If you aren’t sure if an account exists, contact FDA’s registration office for guidance to prevent accidental duplicates.
Once logged into FURLS, select the Device Registration and Listing Module (DRLM). To begin a new registration, click “Register a Medical Device Facility”. The system may prompt you to check if your establishment (or owner) already exists. If none is found (as expected for a first-time registration), proceed with “No existing registration or OO number” and then “Register a New Facility.” Now, you will fill in details about your establishment: legal name, physical address, mailing address, contact person, etc. Ensure accuracy – this becomes FDA’s official record of your facility.
You will also see the Owner/Operator and Official Correspondent info you entered earlier displayed for confirmation. Make any needed corrections by exiting to the Account Management section if something is wrong; otherwise continue.
During the registration workflow, after facility info, you must provide information about the devices that your establishment manufactures or handles. This is the Device Listing part of the process. The interface will guide you through adding device listings. What you need to input here depends on your role:
Take your time with the listing step – it’s very important that each device is accurately listed and associated with the correct regulatory information. Tip: If your device required a premarket clearance/approval, do not try to register/list before that is complete. FDA’s guidance is to wait until you have the clearance in hand, otherwise your listing will be incomplete and your registration technically not finalized for that product. In fact, if that product is your only device, FDA says do not register until after clearance.
After entering all required information for your facility and device listings, you will reach a summary and certification step. Review all details for accuracy. You will then certify that the information is correct and hit the Submit button. At this point, the system will prompt you to enter the PIN and PCN from your fee payment if you haven’t already provided those. This is the last crucial step – without the fee confirmation, FDA will not consider your registration complete. Enter the PIN/PCN to validate that you paid the annual fee.
Once submitted, if all is in order, you should receive a confirmation screen and an email confirmation. Congratulations – your establishment is now registered! You have met the requirements for the current fiscal year (assuming fee payment and info were all correct). The devices you listed are now in FDA’s device registration & listing database.
After initial registration, you can log back into FURLS at any time to maintain your information. If you need to update a device listing (e.g. add a new model or indication), there are options to modify listings. If you stop making a device, you can deactivate that listing. If something was entered incorrectly, you can edit it. We’ll cover updates in a later section, but note that any changes such as new devices, address changes, etc., should be updated as they occur (don’t wait for the annual renewal to fix a critical error).
Also, if you have multiple establishments (facilities), you will register each separately under the same owner/operator account. Common examples: a company with two manufacturing sites, or a manufacturer and a separate storage warehouse (if the warehouse needs to register). Each gets its own registration but linked under one owner.
Timeline:
The actual online registration process can often be done in one sitting, perhaps 1-2 hours if you have all information at hand. The longest lead time item is the fee payment which, as mentioned, can take a couple days to process. Therefore, overall, you should budget a few days to complete initial registration.
Confirmation and Registration Number:
After completion, your firm will appear in FDA’s Establishment Registration & Device Listing database (which is publicly searchable). You can use the registration number assigned to your facility for reference (for example, when dealing with import paperwork or business partners). Remember, though, that number is mainly an identifier – having it doesn’t give you any special status beyond indicating compliance.
Following these steps methodically will ensure you register correctly. Many companies handle this in-house; however, if at any point the process becomes confusing (it can, especially if you have many products or complex company structures), don’t hesitate to seek assistance. FDA provides some online help, and regulatory consultants (like the authors of this site) have done countless FURLS registrations and can guide you or even complete it on your behalf. The key is to get it done accurately so you can move forward with marketing your device without compliance worries.
