• General Data
  • Paying the Annual Registration Fee
  • Registering Your Facility
  • Annual Registration
  • Initial Registration
  • Listing for Combination Products
  • Downloading your listing information from FURLS
  • Reactivating or Deactivating a Registration
  • Reactivating or Deactivating a Device List
  • Types of FURLS Accounts
  • Updating Owner/Operator and Official Correspondent Account Information
  • Updating Registration and Listing Data
  • Waivers

General Information

The Food and Drug Assistants Amendments Human action (FDAAA) of 2007 requires that all registration and listing data (Almanac, Initial or Updates) be submitted electronically unless FDA grants a waiver.

The registration of a medical device establishment is a two-step process. Showtime you must pay the almanac registration user fee. Once you have paid the fee, y'all tin can then consummate the registration process. Your registration is non considered complete until you have

  • paid your annual registration user fee,
  • submitted your registration and list information electronically, and
  • received e-mail notification from FDA that all requirements have been met.

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Paying the Almanac Registration Fee

You may pay the almanac registration fee electronically at the Device Facility User Fee (DFUF) website.

You lot will receive your Payment Identification Number (PIN) when you lot make your payment on the DFUF site. Yous will receive notification of payment confirmation and instructions on obtaining your Payment Confirmation Number (PCN) by email once your payment has cleared. This process tin accept several days, then exist sure to make payment at to the lowest degree a few days before registering.

For additional information, please come across Payment Process.

Once you have received confirmation of your payment, you lot can proceed with registering your facility.

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Registering Your Facility

Registration and listing data is submitted by using FDA's Unified Registration and Listing Organisation (FURLS)/ Device Registration and Listing Module (DRLM).

Each owner/operator must have an business relationship ID and password to employ FURLS. If the owner/operator has designated another person to be the official correspondent, the owner/operator must create a subaccount with a divide account ID and password for the official correspondent.

Firms that are already registered must e'er use their assigned account ID and password. Never create a new FURLS business relationship if you already have one. Creating a new business relationship will prevent you from accessing your current registration information and delay the completion of your right registration.

If you take whatever questions on whether you have an established FURLS business relationship, delight contact the registration and list part at reglist@cdrh.fda.gov.

Assist with resetting your countersign can be establish on our website.

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Annual Registration

  1. Make payment and obtain the Payment Identification Number (Pivot) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
    Annotation: Please follow the detailed instructions in the CDRH Learn module " FURLS Device Registration and Listing Module for Almanac Registration " in performing Steps two-ix below.
  2. Log on to FURLS (https://www.access.fda.gov/oaa/) using your FURLS account ID and countersign.
    If yous are performing your almanac registration, y'all already have an business relationship ID and password, DO NOT CREATE A NEW Account. Creating a new business relationship will prevent you from accessing your electric current registration.
  3. Select the DRLM push (Device Registration and Listing Module).
  4. Select the "Annual Registration" link from the DRLM chief menu. Yous must select the Annual Registration link and consummate this process in order for your establishment to be considered registered for the electric current fiscal year. Selecting this Almanac Registration link will also allow yous to update your registration and/or list data.
  5. Review the registration information for your institution and make any updates.
  6. Review your list information and make updates, if needed.
    If you are an initial importer, review the list of manufacturers of your imported devices.
    If y'all are a foreign institution, review your list of known importers for each of your exported devices. If this data has not been entered previously, information technology must exist entered during the annual registration menstruation in guild to complete registration for the current fiscal year.
  7. Certify that all the data is correct and click on the Submit push.
  8. When prompted, enter both the Pivot and PCN numbers that you received from the Role of Fiscal Management for your payment of the establishment registration fee. This information must be entered in order for FDA to have your registration. If you are not prompted for the Pivot/PCN numbers, delight send an e-mail to reglist@cdrh.fda.gov. Without inbound these numbers, your registration is incomplete.
    Y'all will receive a confirmation screen. One time you receive the confirmation screen, FDA volition consider you registered.
  9. If yous have any changes to your listings, return to the main carte and select Change, Cancel or Reactivate Listings to update your listing information.

If you accept any questions near this process, please email united states of america at reglist@cdrh.fda.gov.

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Initial Registration

  1. Make payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
  2. Go to FURLS at https://world wide web.access.fda.gov/oaa/.
  3. If you have never previously registered a device establishment, you will need to first create a FURLS account for the owner/operator (Come across Types of FURLS Accounts beneath). Note: If you already have an account for this owner/operator, you must log on to FURLS using that user ID and password.
  4. Once you have ready your FURLS account ID and password, select the DRLM button (Device Registration and Listing Module).
  5. Select the link "Register a Medical Device Facility" from the DRLM main menu.
  6. If you do not take any existing registrations, you volition see a folio that asks you to identify any existing owner/operator number or registration number for your establishment. Leave the boxes empty and select "No existing registration or OO number."
  7. If you have existing registrations, you will be asked to confirm that the institution being registered does not already announced in the list that is displayed. If the institution is already registered, do non create a indistinguishable record. If the institution does non appear in the list displayed, select "Annals a New Facility."
  8. The Owner/Operator and Official Contributor information that you entered when you created or updated your FURLS account will be displayed. To brand changes to either the Owner Operator or the Official Correspondent information, you will need to exit the DRLM department of FURLS and return to Account Management. If the information is correct, select "Proceed Registration."
  9. Enter the required information for your facility and select "Continue Registration."
  10. You will be prompted to enter information about the devices that you lot manufacture, procedure, distribute or import. Manufacturers, processors and distributors must listing all devices produced or processed at each facility. Initial importers (facilities that have starting time title to a device imported into the United States) must list all manufacturers of the devices they are importing.
    1. For all facilities EXCEPT initial importers:
      1. Create Listings for devices produced or processed at this facility.
      2. For each list, identify whether your production requires premarket notification/approval or is exempt.
        Note: If a device requires premarket notification clearance or blessing it tin Merely be listed Later on the premarket submission [510(k), PMA, PDP, HDE] is cleared or approved. If this is your simply device list, please do not register your establishment until afterward your premarket submission is cleared or canonical.
      3. 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 lot perform on or to the device
        If your device is exempt from premarket notification/approval, you volition need to practice the following:
        • Obtain the production code. Yous may click hither to find your product code.
        • Exit the premarket submission number bare
        • Enter the product lawmaking in the filter box and click on "Filter"
        • Select the radio button next to the production code and click "Keep"
        • Identify the activities that you perform on or to the device
        • Enter the proprietary proper name(due south)
    2. For Initial Importers (facilities that accept first title to a device imported into the United States):
      1. On the "Identify Manufacturers" page, click on the "Search & Add together Products" push.
      2. Identify the manufacturer by using either its device listing number, establishment registration number, or institution name and address.
      3. On the next page, under the registration data that matches the manufacturer of your devices, select the devices that y'all are importing and click on the "Add Selected Products" button.
  11. Certify that all the information is correct and click on the submit push.
  12. When prompted, enter both the PIN and PCN numbers that you received from the Office of Financial Management for your payment of the establishment registration fee. This information must be entered in order for FDA to have your registration. If you are non prompted for the Pivot/PCN numbers, delight transport an email to reglist@cdrh.fda.gov. Without inbound these numbers, your registration is incomplete.
    You lot will receive a confirmation screen. Once you receive the confirmation screen, FDA volition consider you registered.
  13. If you have whatever changes to your listings, return to the main carte and select Change, Cancel or Reactivate Listings to update your list data.

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List for Combination Products

  • Presentation: Listing Combination Products in FURLS/DRLM (PDF)
    Regulatory Policy and Systems Co-operative
    Partitioning of Risk Management Operations
    Office of Compliance
    Center for Devices and Radiological Health
    May 2012

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Downloading your list information from FURLS

In order to import your listed device into the United States, you'll need to provide the registration number or the possessor/operation number as well every bit the listing number of the device.

Follow the instructions here to download the listing information from FURLS

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Reactivating or Deactivating a Registration

To reactivate a registration record that has non previously had payment-related numbers (PIN/PCN) entered for the current fiscal year, you lot must first pay the user fee by going to the Device Facility User Fee website . After payment has been made, and y'all have obtained both the Payment Identification Number (PIN) and Payment Confirmation Number (PCN), you can proceed with reactivation.

There is no fee associated with deactivating a registration.

Reactivating

  1. Log on to FDA Industry Page (FURLS) at https://www.access.fda.gov/oaa/ with the account ID and password that you previously used to access the institution registration that y'all are reactivating.
  2. Select the DRLM button (Device Registration and Listing Module).
  3. Select the link "Cancel, Deactivate, or Reactivate a Facility Registration."
  4. Select the institution and click on the reactivation button.
  5. Unless the institution is an importer but, you will next exist asked to provide device listings. You lot can either choose from the owner/operator'due south existing listings or, if not found in the existing listings, you tin can create a new listing for your device. Importers will be asked to place the manufacturers of the devices being imported.
  6. Certify that all data is correct and click on the submit button.
  7. If the current fiscal year payment-related numbers (Pivot/PCN) have not previously been entered on the registration record, y'all will be asked to enter them now.

Deactivating

  1. Log on to FDA Industry Page (FURLS) at https://world wide web.access.fda.gov/oaa/ with the account ID and countersign that you lot previously used to admission the establishment registration that yous are deactivating.
  2. Select the DRLM button (Device Registration and Listing Module).
  3. Select the link "Abolish, Deactivate, or Reactivate a Facility Registration".
  4. Select the establishment and click on the deactivation button.
  5. Certify that yous want to deactivate the registration and click on the submit push.

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Reactivating or Deactivating a Device Listing

A device listing can only be reactivated for an establishment that has an active registration.

There is no fee associated with deactivating a device listing.

Reactivating

  1. Log on to FDA Industry Folio (FURLS) at https://world wide web.access.fda.gov/oaa/ with the account ID and password that you previously used to access the establishment registration that you are reactivating.
  2. Select the DRLM button (Device Registration and Listing Module).
  3. Select the link "Change, Abolish, or Reactivate Listing."
  4. Select the list and click on the reactivation button.
  5. Select the establishment that the listing is beingness reactivated for and click on the continue button.
  6. You volition be asked to identify the activity associated with the device. You will also exist asked to identify the proprietary names.
  7. Certify that all information is correct and click on the submit button.

Deactivating

  1. Log on to FDA Manufacture Page (FURLS) at https://www.access.fda.gov/oaa/ with the business relationship ID and password that you lot previously used to access the establishment registration that you are deactivating.
  2. Select the DRLM button (Device Registration and Listing Module).
  3. Select the link "Change, Abolish, or Reactivate Listing."
  4. Select the listing and click on the deactivation button.
  5. Certify that y'all want to deactivate the listing and click on the submit push.

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Types of FURLS Accounts

At that place are two types of accounts in FURLS: owner/operator and official correspondent:

Owner/Operator

An owner/operator is defined as:

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

The possessor/operator is responsible for creating sub-accounts for any official correspondents he/she identifies.

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

Official Correspondent

An official contributor is defined every bit:

  • The person designated by the possessor/ operator of an establishment responsible for the annual registration of the institution and the device listing. The official contributor also receives correspondence from the FDA involving the possessor/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 institution(s) to listings previously entered for the owner/operator
  • View registration and list information for the establishments which have been created by or assigned to them

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Updating Possessor/Operator and Official Correspondent Business relationship Information

To update the possessor/operator's account information:

  1. Log into FURLS using the owner/operator account id and password.
  2. Click on "Edit Contour."
  3. Select the radio button next to "Account." If you are both the owner/operator and official contributor for the facility, then you lot will simply come across i "Account" when you click on "Edit Profile." If you have designated a person to exist the official correspondent for the facility, then y'all will encounter "Business relationship" and "Sub-Account" when you click on "Edit Profile."
  4. Click on "Modify."
  5. Make whatever necessary changes to the account and click "Submit". Whatsoever changes y'all make to the owner/operator account volition be reflected in the Owner/Operator Information for the facility.

To update the official contributor's account information:

  1. The owner/operator must log into FURLS using the owner/operator business relationship id and countersign.
  2. Click on "Edit Contour."
  3. Select the radio push button next to "Sub-Account" to modify the official correspondent's information.
  4. Click on "Change."
  5. Make any necessary changes to the account and click "Submit". The changes you make will automatically be reflected in the official correspondent's information for the facility.

To create new subaccounts for official correspondents:

  1. Log into FURLS using the owner/operator business relationship id and password.
  2. Click on "Create a Subaccount."
  3. Enter the contact information of the official correspondent.
  4. Click on "Keep."
  5. Review the information and click on "Submit."

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

  1. Click on "Device Registration and Listing."
  2. From the primary 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 adjacent to the new official contributor and click on "Proceed."
  5. Review the change and click on "Submit."

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Updating Registration and Listing Information

  1. Updates to Registration and Listing information tin can be washed at any time.
  2. If your establishment has non already paid the current twelvemonth user fee, you must first pay the user fee and obtain the Payment Identification Number (Pivot) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
  3. Log on to FURLS https://www.access.fda.gov/oaa/) using your FURLS business relationship ID and countersign.
    If you already have an account ID and password, DO NOT CREATE A NEW Account. Creating a new account will prevent you from accessing your electric current registration.
  4. Select the DRLM button (Device Registration and Listing Module).
  5. Select the "Change Registration" link to update registration data or select the "Modify, Cancel or Reactivate Listing" link to update your listing information.
  6. Make the necessary changes to your registration or listing information.
  7. Review the changes you lot take made.
  8. Certify that all the information is right and click on the submit push.
  9. When prompted, enter both the PIN and PCN numbers that yous received from the Part of Financial Management for your payment of the establishment registration fee. This information must be entered in order for FDA to accept your registration. If you are not prompted for the Pin/PCN numbers, delight send an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
    You lot will receive a confirmation screen. One time you receive the confirmation screen, FDA volition consider you registered.

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Waivers

The law requires that all registration and list 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
Edifice 66 Room 2621
Silvery Bound, MD 20993-0002

Note: If you lot are granted a waiver, you volition withal be responsible for the establishment registration fee.

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