How to Register and List

• General Information
• Annual Registration Instructions
• Annual Registration for Firms Without a Registration Number
• Initial Registrations
• Types of FURLS Accounts
• Updating Owner/Operator and Official Correspondent Account Information
• Updating Registration and Listing Information
• Combination Products
• Waivers

General Information

The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants you a waiver.

• Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM).
• To use FURLS, each owner/operator must have an account ID and password. If the owner/operator has designated another person to be the official correspondent, then the official correspondent may have a separate account ID and password.
• Firms who are already registered must use their already assigned account ID and password. You SHOULD NOT CREATE a new FURLS account. Creating a new account will prevent you from accessing your current registration information and delay the completion of your correct registration.
• If you have any questions on whether you have an established FURLS account, please contact us at reglist@cdrh.fda.gov.
• Assistance with resetting your password can be found on our website.
• If required to pay the user fee, it is a two step process. First you must pay the fee. Then you can complete your registration. Your registration is not considered complete until you have paid your registration user fee, submitted your information electronically, and have received e-mail notification from FDA that all requirements have been met.
• If not required to pay the user fee, your registration is considered complete once you have submitted your information electronically and have received e-mail notification from FDA that all requirements have been met.

Annual Registration Instructions

1. Determine if your firm needs to pay the user fee. (See Who Must Register, List & Pay the Fee).
2. If required to pay, you must first pay the user fee by going to the Device Facility User Fee website. If not required to pay, go to Step 4.
3. Make payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) before you complete your annual registration.
4. Go to https://www.access.fda.gov/oaa/. Use your FURLS account ID and password to log on to the site.

If you are doing annual registration, you must already have an account ID and password. DO NOT CREATE A NEW ACCOUNT since this will prevent you from accessing your current registration.

1. Select the DRLM button (Device Registration and Listing Module).
2. Select the “Annual Registration” link. You must select the Annual Registration link and complete that process in order for your establishment to be considered registered for the current fiscal year. Selecting this Annual Registration link will also allow you to update your information.
3. Review the registration information for your establishment and make any updates.
4. Everyone (except initial distributors) must also review their listing information and make updates, if needed.
5. Certify that all the information is correct and click on the submit button.
6. If not required to pay, your registration should be complete and you will receive e-mail notification confirming your registration for the current fiscal year from FDA.
7. If required to pay the user fee, you will be prompted to enter both the PIN and PCN numbers. This information must be entered in order for FDA to accept your registration. If you are required to pay the fee and are not prompted for the PIN/PCN number, please send an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.

Annual Registration for Firms Without a Registration Number

1. Determine if you are required to pay the establishment registration fee. (See Who Must Register, List, and Pay the Fee). There is no change in who must pay the fee. If you are not required to pay the fee, skip to step 3.
2. If you are required to pay the fee, follow the instructions online to obtain a Payment Identification Number (PIN) and Payment Confirmation Number (PCN). Once you have obtained both numbers, proceed to step 3
3. Log on to FDA Industry Page (FURLS) at https://www.access.fda.gov/oaa/ with the Account ID and password that you used last year to access your FURLS account.
4. Select the DRLM button (Device Registration and Listing Module).
5. Select Change Registration Information for a Facility.
6. Select the Facility and Click on Update Selected Registration.
7. Review your registration information. (Make any changes if needed by clicking the EDIT button). After any edits or if you do not need to make any edits, check the certification statement box and click submit.
8. If you are required to pay the establishment registration fee, you will be presented with a screen to enter your PIN and PCN. Enter those numbers and click submit.
9. You will receive a confirmation screen. Once you receive the confirmation screen, FDA will consider you registered.
10. If you have any changes to your listings, return to the main menu and select Change, Cancel or Reactivate Listings to update your listing information.

Note: FURLS will not show at first a change in the expiration date of your registration when you complete the above steps.

If youhave any questions about this process, you may email us at reglist@cdrh.fda.gov.

Initial Registration

1. Determine if your firm needs to pay the user fee. (See Who Must Register, List & Pay the Fee)
2. If required to pay, you must first pay the user fee by going to the Device Facility User Fee website. If not required to pay, go to Step 4.
3. Make payment and obtain both the Payment Identification Number (PIN) and Payment Confirmation Number (PCN).
4. Go to https://www.access.fda.gov/oaa/.
5. If you have never previously submitted an establishment registration, you will need to first create a FURLS account for the owner/operator (See Types of FURLS Accounts below). Note: If you already have an account for this owner/operator, you should log on to FURLS using that user ID and password.
6. Once you have set up the FURLS account ID and password, select the DRLM button (Device Registration and Listing Module).
7. Select the link "Register a Medical Device Facility".
8. Enter information about your facility and select "Continue Registration"
9. Create Listings for devices produced or processed at this facility. All facilities are required to list devices except Initial Distributors.

For each listing, you will need to identify whether your product requires premarket notification/approval or is exempt.

If a device requires premarket notification clearance or approval it can ONLY be listed AFTER the premarket submission [510(k), PMA, etc.] is cleared or approved. If this is your only device listing, please do not register your establishment until after your premarket submission is cleared or approved.

If your premarket submission is cleared or approved, you will need to do the following to list your device:

• Enter the premarket submission number
• Enter the proprietary name(s)
• Identify the activities that you perform on or to the device

If your device is exempt from premarket notification/approval, you will need to do the following:

• Identify the product code (prior to logging into FURLS)
• Leave the premarket submission number blank
• Enter the product code in the filter box and click on "Filter"
• Select the radio button next to the product code and click "Continue"
• Identify the activities that you perform on or to the device
• Enter the proprietary name(s)

1. Certify that all the information is correct and click on the submit button.
2. If not required to pay, your registration should be complete and you will receive an e-mail notification confirming your registration for the current fiscal year from FDA.
3. If required to pay the user fee, you will be prompted to enter the payment-related numbers (PIN/PCN). This information must be entered for FDA to accept your registration. If you believe that you are required to pay and you are not prompted for the PIN/PCN number, please send an email to reglist@cdrh.fda.gov. Without these numbers, your registration is incomplete.

Types of FURLS Accounts

There are two types of accounts in FURLS: owner/operator and official correspondent:

An owner/operator is defined as:

• The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registered establishment.

The owner/operator can:

• Create and update all of the official correspondents’ FURLS accounts, including their own account(s)
• Assign official correspondents to registrations
• Create new registrations and listings
• Make changes, updates and cancellations to registrations and listings that they created
• View registration and listing information for the establishments that they created
• View all non-exempt listings belonging to the owner/operator that must be replaced

You will also be required to create a sub-account for any official correspondents you identify.

An official correspondent is defined as:

• The person designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.

The official correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned.

The official correspondent can:

• Create new registrations and listings
• Make changes, updates and cancellations to registrations and listings that have been assigned to them
• Add their establishment(s) to listings previously entered for the owner/operator
• View registration and listing information for the establishments which have been created by or assigned to them

Updating Owner/Operator and Official Correspondent Account Information

To update the owner/operator’s account infor mation:

1. Log into FURLS using the owner/operator account id and password.
2. Click on “Edit Profile”.
3. Select the radio button next to “Account” to modify the owner/operator’s information. If you are both the owner/operator and official correspondent for the facility, then you will only see one “Account” when you click on “Edit Profile”. If you have designated a person to be the official correspondent for the facility, then you will see “Account” and “Sub-Account” when you click on “Edit Profile”.
4. Click on “Modify”.
5. Make any necessary changes to the account and click “Submit”. Any changes you make to the owner/operator account will be reflected in the Owner/Operator Infor mation for the facility.

To update the official correspondent’s account infor mation:

1. The owner/operator must log into FURLS using the owner/operator account id and password.
2. Click on “Edit Profile”.
3. Select the radio button next to “Sub-Account” to modify the official correspondent’s infor mation.
4. Click on “Modify”.
5. Make any necessary changes to the account and click “Submit”. The changes you make will auto matically be reflected in the official correspondent’s infor mation for the facility.

To create new subaccounts for official correspondents:

(If you change the official correspondent of facility and create a new subaccount for this official correspondent, then you will need to do the following steps to update the official correspondent for the facility)

1. Click on “Device Registration and Listing”
2. From the main menu, select “Change Official Correspondent for a Facility” and click “Continue”
3. Check the box next to the facility that you want to change the official correspondent for and click "Continue"
4. Select the box next to the new official correspondent and click on "Continue"
5. Review the change and click on "Submit".

Updating Registration and Listing Information

1. Updates to Registration and Listing information can be done at any time. Updating your information may change whether you are required to pay the establishment registration user fee. You will need to determine if your firm needs to pay the user fee. (See Who Must Register, List & Pay the Fee).
2. If required to pay, you must first pay the user fee by going to the Device Facility User Fee website. If not required to pay, go to Step 4
3. Make payment and obtain both of the payment-related numbers (PIN and PCN) before you can make any updates to your information. Note: Once you have paid the user fee for an establishment for a fiscal year, you may continue to make changes in the listings of that establishment during the fiscal year without an additional charge.
4. Go to https://www.access.fda.gov/oaa/. Use your FURLS account ID and password to log on to the site. DO NOT CREATE A NEW ACCOUNT.
5. Select the DRLM button (Device Registration and Listing Module).
6. Select the “Change Registration” link to update registration information or select the “Change, Cancel or Reactivate Listing” link to update your listing information.
7. Make the necessary changes to your registration or listing information
8. Review the changes you have made.
9. Certify that all the information is correct and click on the submit button.
10. If not required to pay, your registration should be complete and you should receive an e-mail notification confirming your registration for the current fiscal year from FDA.
11. If required to pay the user fee, you will be prompted to enter payment-related numbers (PIN/PCN). This information must be entered for FDA to accept your registration. If you believe that you are required to pay and you are not prompted for the PIN/PCN number, please send an email to reglist@cdrh.fda.gov. Without these numbers, your registration is incomplete.

Waivers

The law requires that all registration and listing information be submitted electronically unless FDA grants a waiver. To apply for a waiver from submitting your registration and listing information electronically, please submit your request with a complete explanation of why you cannot submit your information electronically to:

Food and Drug Administration
CDRH - Office of Compliance
Registration & Listing
10903 New Hampshire Avenue
Building 66 Room 2621
Silver Spring, MD 20993-0002

Note: If you are granted a waiver, you will still be responsible for the establishment registration fee (if required to pay).