How Do You Register Bandicam

General Information
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 Listing
Types of FURLS Accounts
Updating Owner/Operator and Official Contributor Account Data
Updating Registration and Listing Information
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 a waiver.

The registration of a medical device establishment is a 2-footstep process. Starting time yous must pay the almanac registration user fee. In one case you lot take paid the fee, you tin can so consummate the registration process. Your registration is not considered complete until you have

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

Paying the Almanac Registration Fee

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

You volition receive your Payment Identification Number (PIN) when you lot brand your payment on the DFUF site. You will receive notification of payment confirmation and instructions on obtaining your Payment Confirmation Number (PCN) by e-mail once your payment has cleared. This procedure tin accept several days, so be sure to make payment at least a few days before registering.

For additional information, please see Payment Procedure.

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

Registering Your Facility

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

Each possessor/operator must accept an account ID and password to use FURLS. If the possessor/operator has designated another person to be the official contributor, the possessor/operator must create a subaccount with a dissever account ID and countersign for the official correspondent.

Firms that are already registered must ever use their assigned account ID and countersign. Never create a new FURLS business relationship if y'all already have one. Creating a new business relationship will prevent y'all from accessing your current registration information and filibuster the completion of your correct registration.

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

Assistance with resetting your password tin be found on our website.

Annual Registration

Make 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 Learn module " FURLS Device Registration and List Module for Annual Registration " in performing Steps 2-9 below.
Log on to FURLS (https://www.access.fda.gov/oaa/) using your FURLS account ID and password.
If you are performing your annual registration, y'all already have an business relationship ID and password, DO NOT CREATE A NEW Business relationship. Creating a new business relationship volition prevent you from accessing your electric current registration.
Select the DRLM button (Device Registration and List Module).
Select the "Annual Registration" link from the DRLM main carte du jour. Y'all must select the Almanac Registration link and complete this process in lodge for your establishment to exist considered registered for the electric current fiscal year. Selecting this Annual Registration link will also let y'all to update your registration and/or listing data.
Review the registration data for your establishment and make any updates.
Review your listing information and make updates, if needed.
If you are an initial importer, review the listing of manufacturers of your imported devices.
If you are a foreign institution, review your list of known importers for each of your exported devices. If this information has non been entered previously, information technology must exist entered during the annual registration catamenia in order to complete registration for the electric current fiscal year.
Certify that all the information is correct and click on the Submit button.
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 accept your registration. If you are non prompted for the Pin/PCN numbers, delight transport an electronic mail to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
Y'all will receive a confirmation screen. Once you receive the confirmation screen, FDA will consider you registered.
If you take any changes to your listings, return to the main card and select Alter, Abolish or Reactivate Listings to update your listing information.

If you accept any questions nigh this process, please email u.s.a. at reglist@cdrh.fda.gov.

Initial Registration

Make payment and obtain the Payment Identification Number (Pivot) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
Get to FURLS at https://www.access.fda.gov/oaa/.
If y'all have never previously registered a device institution, you will need to first create a FURLS business relationship for the owner/operator (Encounter Types of FURLS Accounts below). Note: If you already have an account for this owner/operator, you must log on to FURLS using that user ID and password.
Once you have prepare up your FURLS account ID and countersign, select the DRLM button (Device Registration and Listing Module).
Select the link "Register a Medical Device Facility" from the DRLM principal carte.
If you exercise not accept whatever existing registrations, y'all will run across a folio that asks you lot 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 lot will be asked to confirm that the institution being registered does non already appear in the list that is displayed. If the institution is already registered, do non create a duplicate record. If the institution does not appear in the list displayed, select "Register a New Facility."
The Possessor/Operator and Official Correspondent information that you lot entered when you created or updated your FURLS business relationship volition exist displayed. To make changes to either the Owner Operator or the Official Correspondent information, you will need to exit the DRLM section of FURLS and render to Account Management. If the data is correct, select "Keep Registration."
Enter the required information for your facility and select "Continue Registration."
You will exist prompted to enter data about the devices that you manufacture, procedure, distribute or import. Manufacturers, processors and distributors must list all devices produced or candy at each facility. Initial importers (facilities that take showtime championship to a device imported into the United states of america) must listing 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/approving or is exempt.
    Note: If a device requires premarket notification clearance or approval information technology tin can But be listed Afterward the premarket submission [510(1000), 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 approved.
  3. If your premarket submission is cleared or canonical, you volition need to do the post-obit to list your device:
    - Enter the premarket submission number
    - Enter the proprietary name(due south)
    - Identify the activities that you perform on or to the device
    If your device is exempt from premarket notification/approval, y'all will need to do the post-obit:
    - Obtain the production code. Yous may click here to find your production code.
    - Leave the premarket submission number bare
    - 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 proper name(south)
2. For Initial Importers (facilities that take commencement title to a device imported into the United states):
  1. On the "Identify Manufacturers" page, click on the "Search & Add Products" push button.
  2. Identify the manufacturer by using either its device list number, establishment registration number, or establishment name 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" button.
Certify that all the information is correct and click on the submit push.
When prompted, enter both the PIN and PCN numbers that you received from the Office of Fiscal Management for your payment of the institution registration fee. This information must be entered in society for FDA to have your registration. If you are not prompted for the PIN/PCN numbers, please send an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
You lot will receive a confirmation screen. In one case you receive the confirmation screen, FDA will consider y'all registered.
If you have any changes to your listings, render to the main menu and select Change, Cancel or Reactivate Listings to update your list data.

Listing for Combination Products

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

Downloading your listing information from FURLS

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

Follow the instructions here to download the listing information from FURLS

Reactivating or Deactivating a Registration

To reactivate a registration record that has not previously had payment-related numbers (Pivot/PCN) entered for the current fiscal twelvemonth, you lot must first pay the user fee by going to the Device Facility User Fee website . Afterwards payment has been made, and you have obtained both the Payment Identification Number (PIN) and Payment Confirmation Number (PCN), you tin can go along 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 password that you previously used to access the establishment registration that you are reactivating.
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 reactivation push button.
Unless the establishment is an importer only, you will next be asked to provide device listings. You can either choose from the owner/operator'due south existing listings or, if not found in the existing listings, you can create a new listing for your device. Importers will exist asked to place the manufacturers of the devices being imported.
Certify that all information is correct and click on the submit button.
If the current fiscal twelvemonth payment-related numbers (PIN/PCN) have non previously been entered on the registration record, y'all will be asked to enter them at present.

Deactivating

Log on to FDA Manufacture Page (FURLS) at https://www.access.fda.gov/oaa/ with the account ID and password that you previously used to admission the establishment registration that you lot are deactivating.
Select the DRLM button (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 want to conciliate the registration and click on the submit push button.

Reactivating or Deactivating a Device Listing

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

There 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 business relationship ID and password that you lot previously used to access the establishment registration that y'all are reactivating.
Select the DRLM button (Device Registration and List Module).
Select the link "Alter, Cancel, or Reactivate Listing."
Select the list and click on the reactivation button.
Select the establishment that the listing is being reactivated for and click on the continue button.
Yous will be asked to identify the activity associated with the device. Yous will also be asked to identify the proprietary names.
Certify that all information is correct and click on the submit button.

Deactivating

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 you are deactivating.
Select the DRLM push button (Device Registration and List 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

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

Owner/Operator

An owner/operator is defined equally:

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

The owner/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 ain business relationship(s)
Assign official correspondents to registrations
Create new registrations and listings
Brand 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 exist replaced

Official Contributor

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 contributor also receives correspondence from the FDA involving the owner/operator and any of the firm's establishments.

The official contributor is responsible for the registration and list data 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(due south) to listings previously entered for the possessor/operator
View registration and listing information for the establishments which have been created by or assigned to them

Updating Possessor/Operator and Official Correspondent Account Information

To update the owner/operator's account information:

Log into FURLS using the possessor/operator account id and password.
Click on "Edit Contour."
Select the radio button next to "Account." If you are both the owner/operator and official correspondent for the facility, then you lot will only come across one "Account" when you click on "Edit Profile." If yous have designated a person to be the official contributor for the facility, then you lot will run into "Account" and "Sub-Business relationship" when you click on "Edit Contour."
Click on "Modify."
Brand 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 Information for the facility.

To update the official correspondent's business relationship data:

The owner/operator must log into FURLS using the possessor/operator account id and password.
Click on "Edit Profile."
Select the radio push next to "Sub-Account" to modify the official contributor'due south information.
Click on "Alter."
Brand whatever necessary changes to the account and click "Submit". The changes you make volition 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 business relationship id and password.
Click on "Create a Subaccount."
Enter the contact information of the official correspondent.
Click on "Continue."
Review the information and click on "Submit."

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

Click on "Device Registration and Listing."
From the main menu, select "Change Official Contributor for a Facility" and click "Keep."
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 "Keep."
Review the alter and click on "Submit."

Updating Registration and Listing Data

Updates to Registration and List information tin can be done at any time.
If your institution has not already paid the current year user fee, you must first 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.access.fda.gov/oaa/) using your FURLS business relationship ID and countersign.
If you lot already have an account ID and password, DO NOT CREATE A NEW ACCOUNT. Creating a new account volition prevent y'all 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 "Change, Cancel or Reactivate Listing" link to update your list data.
Make the necessary changes to your registration or listing information.
Review the changes you have made.
Certify that all the data is right and click on the submit push.
When prompted, enter both the PIN and PCN numbers that you lot received from the Office of Fiscal Direction for your payment of the establishment registration fee. This information must be entered in order for FDA to take your registration. If you are non prompted for the PIN/PCN numbers, please send an electronic mail to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
You will receive a confirmation screen. Once yous receive the confirmation screen, FDA will consider y'all registered.

Waivers

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

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

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