• General Information
  • Paying the Almanac 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 Listing
  • Types of FURLS Accounts
  • Updating Owner/Operator and Official Correspondent Business relationship Data
  • Updating Registration and List Data
  • Waivers

General Information

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

The registration of a medical device institution is a two-step process. First you must pay the annual registration user fee. Once you accept paid the fee, you can and then complete the registration process. Your registration is not considered complete until you have

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

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Paying the Annual Registration Fee

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

Yous volition receive your Payment Identification Number (Pin) when you make your payment on the DFUF site. Y'all volition receive notification of payment confirmation and instructions on obtaining your Payment Confirmation Number (PCN) by email in one case your payment has cleared. This procedure tin have several days, so be sure to make payment at least a few days earlier registering.

For boosted information, please run across Payment Process.

Once you accept received confirmation of your payment, you lot tin continue with registering your facility.

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Registering Your Facility

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

Each possessor/operator must have an account ID and password to utilize FURLS. If the owner/operator has designated another person to be the official correspondent, the possessor/operator must create a subaccount with a split up business relationship 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 accept one. Creating a new account will forbid you from accessing your electric current registration data and delay the completion of your correct registration.

If you take any questions on whether you have an established FURLS account, please contact the registration and listing function at reglist@cdrh.fda.gov.

Assistance with resetting your password tin can be establish on our website.

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Almanac Registration

  1. Brand payment and obtain the Payment Identification Number (Pin) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
    Note: Please follow the detailed instructions in the CDRH Acquire module " FURLS Device Registration and Listing Module for Annual Registration " in performing Steps 2-9 beneath.
  2. Log on to FURLS (https://world wide web.admission.fda.gov/oaa/) using your FURLS business relationship ID and password.
    If you are performing your almanac registration, you already have an business relationship ID and password, Exercise Not CREATE A NEW Account. Creating a new account will prevent you from accessing your current registration.
  3. Select the DRLM button (Device Registration and List Module).
  4. Select the "Annual Registration" link from the DRLM main carte. Y'all must select the Annual Registration link and complete this process in order for your establishment to exist considered registered for the current fiscal year. Selecting this Almanac Registration link will also permit y'all to update your registration and/or listing information.
  5. Review the registration information for your establishment and make any updates.
  6. Review your listing information and make updates, if needed.
    If you are an initial importer, review the list of manufacturers of your imported devices.
    If you are a foreign establishment, review your list of known importers for each of your exported devices. If this information has not been entered previously, it must be entered during the annual registration period in order to complete registration for the current fiscal year.
  7. Certify that all the data is right and click on the Submit push.
  8. When prompted, enter both the Pivot and PCN numbers that you received from the Part of Financial Management for your payment of the establishment registration fee. This information must be entered in social club for FDA to have your registration. If you are not prompted for the Pivot/PCN numbers, please transport an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
    Yous will receive a confirmation screen. Once you receive the confirmation screen, FDA will consider you registered.
  9. If you have any changes to your listings, return to the principal menu and select Modify, Cancel or Reactivate Listings to update your listing information.

If yous have whatever questions about this process, please electronic mail u.s. 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.admission.fda.gov/oaa/.
  3. If you have never previously registered a device establishment, yous will need to kickoff create a FURLS account for the possessor/operator (See Types of FURLS Accounts below). Annotation: If you already have an account for this possessor/operator, you must log on to FURLS using that user ID and password.
  4. In one case you have set upward your FURLS business relationship ID and countersign, select the DRLM button (Device Registration and List Module).
  5. Select the link "Annals a Medical Device Facility" from the DRLM main card.
  6. If you practise non have any existing registrations, yous will meet a page that asks you to identify whatsoever 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 establishment being registered does not already announced in the listing that is displayed. If the establishment is already registered, do not create a duplicate record. If the establishment does not appear in the list displayed, select "Annals a New Facility."
  8. The Owner/Operator and Official Correspondent 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 Contributor information, you volition demand to get out the DRLM department of FURLS and render to Account Direction. If the information is correct, select "Proceed Registration."
  9. Enter the required information for your facility and select "Keep Registration."
  10. Y'all will be prompted to enter information about the devices that y'all industry, procedure, distribute or import. Manufacturers, processors and distributors must list all devices produced or processed at each facility. Initial importers (facilities that take first title to a device imported into the Us) 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 product requires premarket notification/approval or is exempt.
        Note: If a device requires premarket notification clearance or approval it tin can ONLY be listed Afterwards the premarket submission [510(chiliad), PMA, PDP, HDE] is cleared or approved. If this is your but device listing, please do not register your establishment until later on your premarket submission is cleared or canonical.
      3. If your premarket submission is cleared or canonical, you will need to practice the following to list your device:
        • Enter the premarket submission number
        • Enter the proprietary name(southward)
        • Identify the activities that y'all perform on or to the device
        If your device is exempt from premarket notification/approval, y'all will need to practise the following:
        • Obtain the product code. Y'all may click here to find your product code.
        • Get out the premarket submission number blank
        • Enter the product code in the filter box and click on "Filter"
        • Select the radio push button side by side to the product code and click "Go on"
        • Identify the activities that yous perform on or to the device
        • Enter the proprietary name(south)
    2. For Initial Importers (facilities that take first title to a device imported into the United States):
      1. On the "Identify Manufacturers" page, click on the "Search & Add Products" push button.
      2. Place the manufacturer by using either its device listing number, institution registration number, or institution name and address.
      3. On the next folio, nether the registration data that matches the manufacturer of your devices, select the devices that you are importing and click on the "Add Selected Products" push button.
  11. Certify that all the information is correct and click on the submit push button.
  12. When prompted, enter both the Pin and PCN numbers that you lot received from the Office of Financial Management for your payment of the establishment registration fee. This information must be entered in social club for FDA to have your registration. If y'all are not prompted for the Pivot/PCN numbers, please send 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 will consider you lot registered.
  13. If y'all have any changes to your listings, render to the chief carte and select Change, Cancel or Reactivate Listings to update your listing data.

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Listing for Combination Products

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

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Downloading your listing information from FURLS

In club to import your listed device into the United states, y'all'll demand to provide the registration number or the possessor/operation number as well equally the listing number of the device.

Follow the instructions hither to download the listing information from FURLS

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Reactivating or Deactivating a Registration

To reactivate a registration record that has not previously had payment-related numbers (PIN/PCN) entered for the current fiscal year, you must first pay the user fee by going to the Device Facility User Fee website . After payment has been made, and you take obtained both the Payment Identification Number (Pivot) and Payment Confirmation Number (PCN), you lot can proceed with reactivation.

There is no fee associated with deactivating a registration.

Reactivating

  1. Log on to FDA Manufacture Page (FURLS) at https://world wide web.access.fda.gov/oaa/ with the business relationship ID and password that you previously used to access the establishment registration that you are reactivating.
  2. Select the DRLM push button (Device Registration and Listing Module).
  3. Select the link "Cancel, Deactivate, or Reactivate a Facility Registration."
  4. Select the establishment and click on the reactivation button.
  5. Unless the institution is an importer only, you lot volition adjacent be asked to provide device listings. You can either choose from the owner/operator's existing listings or, if not found in the existing listings, y'all can create a new listing for your device. Importers will be asked to identify the manufacturers of the devices being imported.
  6. Certify that all information is correct and click on the submit button.
  7. If the current fiscal year payment-related numbers (Pin/PCN) accept not previously been entered on the registration record, you lot will be asked to enter them now.

Deactivating

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

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Reactivating or Deactivating a Device List

A device listing tin can merely be reactivated for an establishment that has an agile registration.

There is no fee associated with deactivating a device list.

Reactivating

  1. Log on to FDA Industry Page (FURLS) at https://www.access.fda.gov/oaa/ with the account ID and countersign 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, Cancel, 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 go on push.
  6. You will be asked to identify the action associated with the device. You will also be asked to identify the proprietary names.
  7. Certify that all information is correct and click on the submit push button.

Deactivating

  1. Log on to FDA Industry Page (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 deactivating.
  2. Select the DRLM button (Device Registration and Listing Module).
  3. Select the link "Alter, Abolish, or Reactivate Listing."
  4. Select the listing and click on the deactivation button.
  5. Certify that you want to deactivate the listing and click on the submit button.

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Types of FURLS Accounts

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

Owner/Operator

An possessor/operator is defined equally:

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

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

The owner/operator tin can:

  • Create and update all of the official correspondents' FURLS accounts, including their own business relationship(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 data for the establishments that they created
  • View all not-exempt listings belonging to the owner/operator that must be replaced

Official Correspondent

An official correspondent is divers as:

  • The person designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device list. 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 list information for each institution to which he/she is assigned.

The official correspondent can:

  • Create new registrations and listings
  • Brand changes, updates and cancellations to registrations and listings that have been assigned to them
  • Add together 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

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Updating Owner/Operator and Official Correspondent Account Information

To update the owner/operator'southward business relationship data:

  1. Log into FURLS using the owner/operator business relationship id and password.
  2. Click on "Edit Profile."
  3. Select the radio button next to "Account." If you are both the owner/operator and official correspondent for the facility, then you volition only run into 1 "Account" when you click on "Edit Profile." If you have designated a person to be the official correspondent for the facility, then you lot will see "Account" and "Sub-Business relationship" when you click on "Edit Contour."
  4. Click on "Modify."
  5. Make any necessary changes to the account and click "Submit". Whatever changes yous make to the owner/operator account volition be reflected in the Owner/Operator Data for the facility.

To update the official correspondent'southward account information:

  1. The owner/operator must log into FURLS using the possessor/operator account id and password.
  2. Click on "Edit Contour."
  3. Select the radio button next to "Sub-Account" to modify the official correspondent'due south 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 account id and password.
  2. Click on "Create a Subaccount."
  3. Enter the contact information of the official correspondent.
  4. Click on "Go along."
  5. Review the information and click on "Submit."

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

  1. Click on "Device Registration and List."
  2. From the main menu, select "Modify Official Contributor for a Facility" and click "Continue."
  3. Check the box side by side to the facility that you want to change the official correspondent for and click "Continue."
  4. Select the box adjacent to the new official correspondent and click on "Continue."
  5. Review the change and click on "Submit."

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Updating Registration and Listing Information

  1. Updates to Registration and Listing information can be done at any time.
  2. If your establishment has not already paid the current year user fee, yous must outset pay the user fee and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
  3. Log on to FURLS https://world wide web.access.fda.gov/oaa/) using your FURLS account ID and countersign.
    If you already have an account ID and password, Do Not CREATE A NEW Business relationship. Creating a new account will foreclose you from accessing your current registration.
  4. Select the DRLM push button (Device Registration and List Module).
  5. Select the "Change Registration" link to update registration data or select the "Change, Abolish or Reactivate Listing" link to update your listing information.
  6. Brand the necessary changes to your registration or listing information.
  7. Review the changes you have made.
  8. Certify that all the data is right and click on the submit push.
  9. When prompted, enter both the PIN and PCN numbers that y'all received from the Office of Fiscal Management for your payment of the establishment registration fee. This information must be entered in order for FDA to take your registration. If yous are not prompted for the Pivot/PCN numbers, please transport an email to reglist@cdrh.fda.gov. Without inbound these numbers, your registration is incomplete.
    You volition receive a confirmation screen. Once y'all receive the confirmation screen, FDA will consider you registered.

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Waivers

The law requires that all registration and listing information exist submitted electronically unless FDA grants a waiver. To utilize for a waiver from submitting your registration and listing data electronically, delight submit your request with a complete caption of why you cannot submit your information electronically to:

Food and Drug Assistants
CDRH - Role of Compliance
Registration & Listing
10903 New Hampshire Avenue
Building 66 Room 2621
Silver Jump, MD 20993-0002

Annotation: If you are granted a waiver, you volition still exist responsible for the establishment registration fee.

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