How Do I Register At Fda

Full general Data
Paying the Annual Registration Fee
Registering Your Facility
Almanac Registration
Initial Registration
List 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 Possessor/Operator and Official Correspondent Account Information
Updating Registration and Listing Information
Waivers

General Data

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

The registration of a medical device establishment is a two-step process. First you must pay the almanac registration user fee. Once you take paid the fee, you can then complete the registration process. Your registration is not considered complete until y'all have

paid your annual registration user fee,
submitted your registration and listing information electronically, and
received email notification from FDA that all requirements take been met.

Paying the Annual Registration Fee

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

You will receive your Payment Identification Number (Pin) when you make your payment on the DFUF site. You volition receive notification of payment confirmation and instructions on obtaining your Payment Confirmation Number (PCN) by email once your payment has cleared. This process can take several days, so be sure to brand payment at least a few days before registering.

For additional information, please see Payment Process.

Once you have received confirmation of your payment, you lot tin go on with registering your facility.

Registering Your Facility

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

Each owner/operator must have an business relationship ID and password to use FURLS. If the possessor/operator has designated another person to exist the official correspondent, the owner/operator must create a subaccount with a split up account ID and countersign for the official correspondent.

Firms that are already registered must always use their assigned account ID and password. Never create a new FURLS business relationship if yous already have one. Creating a new account volition preclude yous from accessing your current registration information and delay the completion of your right registration.

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

Assistance with resetting your countersign can be found on our website.

Annual Registration

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 2-9 below.
Log on to FURLS (https://www.admission.fda.gov/oaa/) using your FURLS account ID and countersign.
If yous are performing your annual registration, you already accept an business relationship ID and password, DO NOT CREATE A NEW ACCOUNT. Creating a new account volition prevent you from accessing your current registration.
Select the DRLM button (Device Registration and Listing Module).
Select the "Almanac Registration" link from the DRLM chief bill of fare. You must select the Annual Registration link and complete this process in guild for your establishment to be considered registered for the current fiscal year. Selecting this Annual Registration link will also let you to update your registration and/or listing information.
Review the registration information for your institution and make any updates.
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 menstruation in social club to complete registration for the current fiscal year.
Certify that all the information is right and click on the Submit button.
When prompted, enter both the Pin and PCN numbers that you received from the Office of Financial Direction for your payment of the establishment registration fee. This information must exist entered in society 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.
Y'all will receive a confirmation screen. One time you receive the confirmation screen, FDA will consider you lot registered.
If you accept any changes to your listings, return to the chief menu and select Alter, Cancel or Reactivate Listings to update your listing information.

If y'all have any questions nigh this process, please email us at reglist@cdrh.fda.gov.

Initial Registration

Make payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
Become to FURLS at https://www.access.fda.gov/oaa/.
If you lot have never previously registered a device institution, you volition need to first create a FURLS account for the owner/operator (See Types of FURLS Accounts beneath). Note: If yous already accept an account for this owner/operator, y'all must log on to FURLS using that user ID and password.
Once you have prepare your FURLS account ID and countersign, select the DRLM push button (Device Registration and List Module).
Select the link "Register a Medical Device Facility" from the DRLM main carte du jour.
If you do not have whatever existing registrations, you will see a folio that asks y'all 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."
If you have existing registrations, you will be asked to confirm that the establishment being registered does non already appear in the listing that is displayed. If the institution is already registered, exercise non create a indistinguishable record. If the establishment does non appear in the list displayed, select "Register a New Facility."
The Possessor/Operator and Official Correspondent information that yous entered when yous created or updated your FURLS account will be displayed. To make changes to either the Owner Operator or the Official Correspondent information, y'all will need to leave the DRLM section of FURLS and render to Account Management. If the data is correct, select "Continue Registration."
Enter the required information for your facility and select "Keep Registration."
You will be prompted to enter information about the devices that you industry, process, distribute or import. Manufacturers, processors and distributors must list all devices produced or candy at each facility. Initial importers (facilities that have offset 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 approval information technology can Only exist listed AFTER the premarket submission [510(1000), PMA, PDP, HDE] is cleared or approved. If this is your but device listing, please do not annals your establishment until afterwards your premarket submission is cleared or canonical.
  3. If your premarket submission is cleared or approved, yous will demand to do the following to listing your device:
    - Enter the premarket submission number
    - Enter the proprietary proper name(due south)
    - Identify the activities that you perform on or to the device
    If your device is exempt from premarket notification/approval, you will demand to do the following:
    - Obtain the product code. You may click here to find your product lawmaking.
    - Leave the premarket submission number bare
    - Enter the production code in the filter box and click on "Filter"
    - Select the radio button side by side to the product code and click "Continue"
    - Identify the activities that you perform on or to the device
    - Enter the proprietary name(s)
2. For Initial Importers (facilities that take beginning title to a device imported into the United States):
  1. On the "Identify Manufacturers" page, click on the "Search & Add together Products" button.
  2. Identify the manufacturer past using either its device listing number, establishment registration number, or establishment proper noun and accost.
  3. On the next folio, under the registration information that matches the manufacturer of your devices, select the devices that you are importing and click on the "Add Selected Products" push.
Certify that all the information is right and click on the submit push button.
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 data must be entered in order for FDA to accept your registration. If y'all are non prompted for the Pivot/PCN numbers, please ship an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
You will receive a confirmation screen. Once you receive the confirmation screen, FDA will consider y'all registered.
If you take any changes to your listings, return to the chief card and select Change, Cancel or Reactivate Listings to update your listing information.

Listing for Combination Products

Presentation: List Combination Products in FURLS/DRLM (PDF)
Regulatory Policy and Systems Co-operative
Segmentation of Risk Management Operations
Office of Compliance
Centre for Devices and Radiological Wellness
May 2012

Downloading your list information from FURLS

In club to import your listed device into the United States, you'll demand to provide the registration number or the possessor/operation number likewise equally the listing number of the device.

Follow the instructions hither to download the listing data from FURLS

Reactivating or Deactivating a Registration

To reactivate a registration record that has not previously had payment-related numbers (PIN/PCN) entered for the electric current financial year, you must first pay the user fee past going to the Device Facility User Fee website . Afterward payment has been made, and yous have obtained both the Payment Identification Number (PIN) and Payment Confirmation Number (PCN), you can continue with reactivation.

There is no fee associated with deactivating a registration.

Reactivating

Log on to FDA Manufacture Page (FURLS) at https://www.access.fda.gov/oaa/ with the account ID and countersign that yous previously used to access the establishment registration that you are reactivating.
Select the DRLM button (Device Registration and List Module).
Select the link "Cancel, Deactivate, or Reactivate a Facility Registration."
Select the establishment and click on the reactivation button.
Unless the institution is an importer only, y'all will next 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, you tin can create a new listing for your device. Importers will be asked to identify the manufacturers of the devices being imported.
Certify that all information is correct and click on the submit button.
If the current financial year payment-related numbers (PIN/PCN) take not previously been entered on the registration record, you will be asked to enter them now.

Deactivating

Log on to FDA Industry Folio (FURLS) at https://www.access.fda.gov/oaa/ with the account ID and countersign that you previously used to admission the establishment registration that you are deactivating.
Select the DRLM push (Device Registration and Listing Module).
Select the link "Cancel, Deactivate, or Reactivate a Facility Registration".
Select the establishment and click on the deactivation button.
Certify that y'all desire to deactivate the registration and click on the submit push button.

Reactivating or Deactivating a Device List

A device listing can but be reactivated for an institution that has an active registration.

At that place is no fee associated with deactivating a device listing.

Reactivating

Log on to FDA Industry Page (FURLS) at https://www.access.fda.gov/oaa/ with the account ID and password that you lot previously used to admission the institution registration that y'all are reactivating.
Select the DRLM button (Device Registration and Listing Module).
Select the link "Change, Cancel, or Reactivate Listing."
Select the listing and click on the reactivation button.
Select the establishment that the list is being reactivated for and click on the continue button.
You volition be asked to identify the action associated with the device. Yous will besides exist asked to identify the proprietary names.
Certify that all data is correct and click on the submit button.

Deactivating

Log on to FDA Manufacture Folio (FURLS) at https://www.access.fda.gov/oaa/ with the business relationship ID and password that yous previously used to access the establishment registration that you are deactivating.
Select the DRLM button (Device Registration and Listing Module).
Select the link "Change, Cancel, or Reactivate Listing."
Select the list and click on the deactivation button.
Certify that you want to deactivate the listing and click on the submit button.

Types of FURLS Accounts

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

Possessor/Operator

An owner/operator is defined as:

The corporation, subsidiary, affiliated visitor, 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(south)
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 possessor/operator that must exist replaced

Official Correspondent

An official contributor is divers as:

The person designated by the owner/ operator of an institution responsible for the almanac registration of the institution 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 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 list information for the establishments which take been created by or assigned to them

Updating Owner/Operator and Official Contributor Account Information

To update the owner/operator's business relationship information:

Log into FURLS using the owner/operator account id and password.
Click on "Edit Profile."
Select the radio push button next to "Account." If you are both the possessor/operator and official correspondent for the facility, then you will only run into one "Account" when you click on "Edit Contour." If you take designated a person to be the official correspondent for the facility, and then y'all will come across "Business relationship" and "Sub-Account" when yous click on "Edit Profile."
Click on "Modify."
Brand any necessary changes to the account and click "Submit". Whatever changes you lot make to the owner/operator account will be reflected in the Owner/Operator Data for the facility.

To update the official contributor's business relationship information:

The owner/operator must log into FURLS using the owner/operator business relationship id and password.
Click on "Edit Profile."
Select the radio button adjacent to "Sub-Account" to change the official correspondent's information.
Click on "Change."
Make whatever necessary changes to the account and click "Submit". The changes yous make will automatically be reflected in the official correspondent's information for the facility.

To create new subaccounts for official correspondents:

Log into FURLS using the owner/operator account id and password.
Click on "Create a Subaccount."
Enter the contact information of the official correspondent.
Click on "Keep."
Review the information and click on "Submit."

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

Click on "Device Registration and List."
From the main menu, select "Change Official Correspondent for a Facility" and click "Continue."
Check the box next to the facility that you want to change the official contributor for and click "Go along."
Select the box side by side to the new official correspondent and click on "Continue."
Review the change and click on "Submit."

Updating Registration and List Information

Updates to Registration and List information tin be done at any time.
If your establishment has not already paid the current year user fee, you must showtime pay the user fee and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
Log on to FURLS https://www.admission.fda.gov/oaa/) using your FURLS account ID and password.
If you lot already have an business relationship ID and countersign, Practice Not CREATE A NEW Business relationship. Creating a new account will prevent you from accessing your current registration.
Select the DRLM button (Device Registration and Listing Module).
Select the "Change Registration" link to update registration information or select the "Modify, Cancel or Reactivate Listing" link to update your listing information.
Make the necessary changes to your registration or listing information.
Review the changes you lot have made.
Certify that all the information is right and click on the submit push button.
When prompted, enter both the PIN and PCN numbers that you received from the Office of Fiscal Direction for your payment of the establishment registration fee. This data must be entered in guild for FDA to have your registration. If you are non prompted for the PIN/PCN numbers, please send an email to reglist@cdrh.fda.gov. Without inbound these numbers, your registration is incomplete.
You will receive a confirmation screen. Once you receive the confirmation screen, FDA volition consider yous registered.

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 data electronically, please submit your request with a complete explanation of why y'all 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, Dr. 20993-0002

Note: If you are granted a waiver, you will still be responsible for the institution registration fee.