How To Register Fda Tutorial

Full general Data
Paying the Annual Registration Fee
Registering Your Facility
Almanac Registration
Initial Registration
Listing for Combination Products
Downloading your listing data 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 Data
Waivers

Full general Information

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

The registration of a medical device institution is a 2-step process. Start you must pay the annual registration user fee. Once you have paid the fee, you tin then complete the registration procedure. Your registration is not considered complete until you have

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

Paying the Annual Registration Fee

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

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

For additional information, delight meet Payment Process.

Once you accept received confirmation of your payment, you tin go along with registering your facility.

Registering Your Facility

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

Each possessor/operator must accept an account ID and password to employ FURLS. If the owner/operator has designated another person to exist the official correspondent, the owner/operator must create a subaccount with a divide account ID and password for the official contributor.

Firms that are already registered must always use their assigned account ID and countersign. Never create a new FURLS account if you already have one. Creating a new account will prevent y'all 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 the registration and listing office at reglist@cdrh.fda.gov.

Assistance with resetting your countersign can be institute 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.
Notation: Delight follow the detailed instructions in the CDRH Acquire module " FURLS Device Registration and Listing Module for Almanac Registration " in performing Steps 2-9 below.
Log on to FURLS (https://www.access.fda.gov/oaa/) using your FURLS business relationship ID and countersign.
If yous are performing your annual registration, you already have an account ID and password, Practise NOT CREATE A NEW Business relationship. Creating a new account will prevent you from accessing your current registration.
Select the DRLM push (Device Registration and Listing Module).
Select the "Almanac Registration" link from the DRLM master menu. You must select the Almanac Registration link and complete this procedure in order for your establishment to be considered registered for the current fiscal year. Selecting this Annual Registration link volition also allow you lot to update your registration and/or listing information.
Review the registration information for your establishment and make whatsoever updates.
Review your listing information and make updates, if needed.
If you lot are an initial importer, review the list of manufacturers of your imported devices.
If you are a foreign establishment, review your listing of known importers for each of your exported devices. If this data has non been entered previously, it must be entered during the almanac registration menses in social club to complete registration for the current financial twelvemonth.
Certify that all the data is right and click on the Submit button.
When prompted, enter both the Pivot and PCN numbers that you received from the Role of Fiscal Direction for your payment of the establishment registration fee. This information must exist entered in lodge for FDA to have your registration. If you are not 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 volition receive a confirmation screen. Once you receive the confirmation screen, FDA will consider you registered.
If you lot accept any changes to your listings, return to the principal menu and select Modify, Cancel or Reactivate Listings to update your listing data.

If you have whatever questions near 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.
Get to FURLS at https://www.access.fda.gov/oaa/.
If you have never previously registered a device establishment, you will need to outset create a FURLS account for the owner/operator (See Types of FURLS Accounts below). Note: If you already accept an account for this owner/operator, you lot must log on to FURLS using that user ID and password.
Once you have prepare your FURLS account ID and password, select the DRLM push (Device Registration and Listing Module).
Select the link "Register a Medical Device Facility" from the DRLM main menu.
If you practice not have any existing registrations, you will meet a page that asks you to place 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 exist asked to confirm that the institution being registered does non already appear in the list that is displayed. If the establishment is already registered, practise not create a duplicate record. If the institution does not appear in the listing displayed, select "Register a New Facility."
The Owner/Operator and Official Correspondent information that y'all entered when you created or updated your FURLS account volition be displayed. To make changes to either the Owner Operator or the Official Correspondent data, y'all will need to exit the DRLM section of FURLS and return to Account Direction. If the data is correct, select "Keep Registration."
Enter the required information for your facility and select "Continue Registration."
Yous will be prompted to enter information about the devices that you industry, process, distribute or import. Manufacturers, processors and distributors must listing all devices produced or processed at each facility. Initial importers (facilities that take showtime 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 candy at this facility.
  2. For each listing, identify whether your production requires premarket notification/approving or is exempt.
    Note: If a device requires premarket notification clearance or approving it tin can ONLY exist listed Afterward the premarket submission [510(k), PMA, PDP, HDE] is cleared or canonical. If this is your only device listing, delight do not annals your institution until after your premarket submission is cleared or approved.
  3. If your premarket submission is cleared or approved, you will need to exercise the post-obit to listing your device:
    - Enter the premarket submission number
    - Enter the proprietary name(s)
    - Identify the activities that yous perform on or to the device
    If your device is exempt from premarket notification/approval, you volition need to exercise the following:
    - Obtain the product code. You may click here to find your product code.
    - Leave the premarket submission number bare
    - Enter the product code in the filter box and click on "Filter"
    - Select the radio push button side by side to the product lawmaking and click "Continue"
    - Identify the activities that you perform on or to the device
    - Enter the proprietary name(southward)
2. For Initial Importers (facilities that have showtime title to a device imported into the United states):
  1. On the "Identify Manufacturers" page, click on the "Search & Add Products" push.
  2. Identify the manufacturer by using either its device listing number, establishment registration number, or establishment name and address.
  3. On the side by side page, under the registration information that matches the manufacturer of your devices, select the devices that yous are importing and click on the "Add together 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 Financial Direction for your payment of the institution 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, please transport an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
You will receive a confirmation screen. Once you lot receive the confirmation screen, FDA will consider you registered.
If you accept any changes to your listings, render to the main bill of fare and select Change, Abolish or Reactivate Listings to update your list data.

Listing for Combination Products

Presentation: List Combination Products in FURLS/DRLM (PDF)
Regulatory Policy and Systems Branch
Sectionalization of Risk Management Operations
Function of Compliance
Center for Devices and Radiological Health
May 2012

Downloading your list information from FURLS

In order to import your listed device into the United states, you lot'll demand to provide the registration number or the owner/functioning number too equally 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 tape that has not previously had payment-related numbers (PIN/PCN) entered for the current fiscal year, you must kickoff pay the user fee by going to the Device Facility User Fee website . Afterward payment has been fabricated, and you take obtained both the Payment Identification Number (Pin) and Payment Confirmation Number (PCN), y'all tin proceed with reactivation.

There is no fee associated with deactivating a registration.

Reactivating

Log on to FDA Industry Page (FURLS) at https://world wide web.admission.fda.gov/oaa/ with the account ID and password that you previously used to access the establishment registration that yous are reactivating.
Select the DRLM push button (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, yous volition 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, y'all tin create a new list for your device. Importers will be asked to identify the manufacturers of the devices beingness imported.
Certify that all information is correct and click on the submit button.
If the current fiscal year payment-related numbers (Pivot/PCN) have not previously been entered on the registration record, you volition be asked to enter them now.

Deactivating

Log on to FDA Industry Page (FURLS) at https://world wide web.access.fda.gov/oaa/ with the account ID and countersign 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 "Cancel, Deactivate, or Reactivate a Facility Registration".
Select the establishment and click on the deactivation button.
Certify that y'all want to deactivate the registration and click on the submit button.

Reactivating or Deactivating a Device Listing

A device listing can simply exist reactivated for an establishment 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 countersign that yous previously used to access the establishment registration that you 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 listing is being reactivated for and click on the proceed button.
You lot will be asked to identify the activity associated with the device. Yous will also exist asked to identify the proprietary names.
Certify that all information is correct and click on the submit button.

Deactivating

Log on to FDA Manufacture Page (FURLS) at https://world wide web.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 button (Device Registration and List Module).
Select the link "Alter, Cancel, or Reactivate List."
Select the listing and click on the deactivation button.
Certify that you want to deactivate the listing and click on the submit push button.

Types of FURLS Accounts

There 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 direct 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 exist replaced

Official Correspondent

An official correspondent is defined as:

The person designated by the owner/ operator of an establishment responsible for the annual registration of the institution and the device listing. The official contributor too receives correspondence from the FDA involving the owner/operator and any of the business firm's establishments.

The official correspondent is responsible for the registration and listing data for each establishment 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 their establishment(s) to listings previously entered for the owner/operator
View registration and listing information for the establishments which have been created past or assigned to them

Updating Owner/Operator and Official Correspondent 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 Contour."
Select the radio push button side by side to "Account." If y'all are both the owner/operator and official correspondent for the facility, so yous will only meet one "Account" when you click on "Edit Contour." If y'all have designated a person to be the official correspondent for the facility, then you will come across "Account" and "Sub-Account" when you click on "Edit Profile."
Click on "Modify."
Brand any necessary changes to the account and click "Submit". Any changes you make to the possessor/operator account will be reflected in the Owner/Operator Information for the facility.

To update the official contributor'southward account information:

The owner/operator must log into FURLS using the owner/operator account id and password.
Click on "Edit Profile."
Select the radio push next to "Sub-Business relationship" to modify the official correspondent's information.
Click on "Change."
Make any necessary changes to the business relationship and click "Submit". The changes you make will automatically exist 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 "Proceed."
Review the information and click on "Submit."

(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)

Click on "Device Registration and List."
From the main menu, select "Change Official Correspondent for a Facility" and click "Continue."
Bank check the box next to the facility that y'all want to modify the official correspondent for and click "Keep."
Select the box adjacent to the new official correspondent and click on "Continue."
Review the change and click on "Submit."

Updating Registration and Listing Information

Updates to Registration and List information can exist done at whatsoever time.
If your establishment has not already paid the current year 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.
Log on to FURLS https://www.access.fda.gov/oaa/) using your FURLS business relationship ID and password.
If you already have an account ID and password, DO NOT CREATE A NEW Business relationship. Creating a new account will prevent yous from accessing your current registration.
Select the DRLM button (Device Registration and Listing Module).
Select the "Change Registration" link to update registration data or select the "Change, Cancel or Reactivate Listing" link to update your listing information.
Brand the necessary changes to your registration or listing information.
Review the changes y'all take fabricated.
Certify that all the data 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 Direction 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, please send an e-mail to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
Yous will receive a confirmation screen. In one case you receive the confirmation screen, FDA will consider yous registered.

Waivers

The police requires that all registration and list information be submitted electronically unless FDA grants a waiver. To use for a waiver from submitting your registration and list information electronically, delight submit your asking with a complete explanation of why you cannot submit your information electronically to:

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

Notation: If y'all are granted a waiver, you volition still exist responsible for the establishment registration fee.