How To Register At&t El52209 Handset

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 Possessor/Operator and Official Correspondent Business relationship Information
Updating Registration and Listing Information
Waivers

General Information

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

The registration of a medical device establishment is a two-footstep procedure. First yous must pay the annual registration user fee. In one case yous take paid the fee, you can then complete the registration process. Your registration is non 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

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

Yous will receive your Payment Identification Number (PIN) when y'all make your payment on the DFUF site. You will receive notification of payment confirmation and instructions on obtaining your Payment Confirmation Number (PCN) past electronic mail one time your payment has cleared. This procedure tin take several days, so exist sure to make payment at least a few days before registering.

For boosted data, please see Payment Process.

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

Registering Your Facility

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

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

Firms that are already registered must always employ their assigned account ID and countersign. Never create a new FURLS account if yous already have one. Creating a new account will forbid y'all from accessing your current registration information and delay the completion of your correct registration.

If y'all accept whatsoever questions on whether you take an established FURLS account, delight contact the registration and listing part at reglist@cdrh.fda.gov.

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

Almanac Registration

Make payment and obtain the Payment Identification Number (Pin) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
Notation: Please follow the detailed instructions in the CDRH Learn module " FURLS Device Registration and Listing Module for Annual Registration " in performing Steps 2-9 beneath.
Log on to FURLS (https://www.access.fda.gov/oaa/) using your FURLS account ID and password.
If y'all are performing your almanac registration, yous already have an account ID and password, Do NOT CREATE A NEW ACCOUNT. Creating a new account will prevent you lot from accessing your electric current registration.
Select the DRLM button (Device Registration and Listing Module).
Select the "Almanac Registration" link from the DRLM main carte. You must select the Annual Registration link and consummate this process in gild for your establishment to be considered registered for the current fiscal twelvemonth. Selecting this Annual Registration link volition also allow you to update your registration and/or listing data.
Review the registration information for your establishment and make whatsoever updates.
Review your listing data and brand updates, if needed.
If you are an initial importer, review the list of manufacturers of your imported devices.
If you lot are a strange establishment, review your listing of known importers for each of your exported devices. If this information has non been entered previously, it must exist entered during the annual registration period in club to consummate registration for the current fiscal twelvemonth.
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 data must be entered in guild for FDA to accept your registration. If you are not prompted for the Pivot/PCN numbers, delight send an email to reglist@cdrh.fda.gov. Without inbound these numbers, your registration is incomplete.
Yous will receive a confirmation screen. One time you receive the confirmation screen, FDA will consider you registered.
If you have any changes to your listings, return to the master card and select Change, Cancel or Reactivate Listings to update your listing information.

If you have any questions about this process, delight 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.
Go to FURLS at https://www.access.fda.gov/oaa/.
If y'all accept never previously registered a device establishment, you will need to showtime create a FURLS account for the owner/operator (See Types of FURLS Accounts below). Notation: If you already have an business relationship for this possessor/operator, you must log on to FURLS using that user ID and countersign.
In one case you take set 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 master carte du jour.
If you lot do not take any existing registrations, you will see a page that asks you to identify any existing possessor/operator number or registration number for your establishment. Go out the boxes empty and select "No existing registration or OO number."
If yous take existing registrations, you will be asked to ostend that the establishment existence registered does non already appear in the list that is displayed. If the establishment is already registered, do not create a indistinguishable record. If the establishment does not appear in the listing displayed, select "Register a New Facility."
The Owner/Operator and Official Correspondent information that you lot entered when you lot created or updated your FURLS account will be displayed. To make changes to either the Owner Operator or the Official Contributor information, you lot will demand to leave the DRLM department of FURLS and return to Account Management. If the information is right, 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 manufacture, procedure, distribute or import. Manufacturers, processors and distributors must listing all devices produced or candy at each facility. Initial importers (facilities that take first title to a device imported into the United states of america) 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 listing, identify whether your product requires premarket notification/approval or is exempt.
    Note: If a device requires premarket notification clearance or approval it can Simply be listed After the premarket submission [510(k), PMA, PDP, HDE] is cleared or approved. If this is your only device list, please do not register your establishment until after your premarket submission is cleared or canonical.
  3. If your premarket submission is cleared or approved, y'all will need to do the following to list your device:
    - Enter the premarket submission number
    - Enter the proprietary proper name(southward)
    - Place the activities that you perform on or to the device
    If your device is exempt from premarket notification/approval, you will demand to practise the post-obit:
    - Obtain the production lawmaking. You may click here to find your production code.
    - Leave the premarket submission number blank
    - Enter the production code in the filter box and click on "Filter"
    - Select the radio button next to the production code and click "Continue"
    - Identify the activities that y'all perform on or to the device
    - Enter the proprietary proper noun(s)
2. For Initial Importers (facilities that accept start championship to a device imported into the The states):
  1. On the "Place Manufacturers" folio, click on the "Search & Add Products" button.
  2. Identify the manufacturer by using either its device listing number, establishment registration number, or establishment proper name and address.
  3. On the next page, 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 Pivot and PCN numbers that you received from the Office of Fiscal Management for your payment of the establishment registration fee. This data must be entered in social club for FDA to accept your registration. If you are not prompted for the Pin/PCN numbers, please send an e-mail to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.
You will receive a confirmation screen. In one case yous receive the confirmation screen, FDA will consider you registered.
If you accept any changes to your listings, return to the primary menu and select Modify, Cancel or Reactivate Listings to update your listing information.

List for Combination Products

Presentation: Listing Combination Products in FURLS/DRLM (PDF)
Regulatory Policy and Systems Branch
Division of Gamble Management Operations
Function of Compliance
Eye for Devices and Radiological Health
May 2012

Downloading your listing information from FURLS

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

Follow the instructions here to download the list information 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 fiscal year, you must start pay the user fee by going to the Device Facility User Fee website . After payment has been made, and you accept obtained both the Payment Identification Number (Pivot) and Payment Confirmation Number (PCN), you lot tin can 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.access.fda.gov/oaa/ with the account ID and password that you previously used to access the institution registration that you are reactivating.
Select the DRLM button (Device Registration and Listing Module).
Select the link "Abolish, 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. Yous can either choose from the owner/operator's existing listings or, if not establish in the existing listings, you can create a new listing for your device. Importers volition be asked to identify the manufacturers of the devices being imported.
Certify that all data is right and click on the submit button.
If the current financial yr payment-related numbers (Pivot/PCN) accept not previously been entered on the registration record, you lot volition be asked to enter them at present.

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 admission the establishment registration that you are deactivating.
Select the DRLM button (Device Registration and List Module).
Select the link "Abolish, 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 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 list.

Reactivating

Log on to FDA Industry Folio (FURLS) at https://www.admission.fda.gov/oaa/ with the business relationship ID and password that you previously used to access the establishment registration that you are reactivating.
Select the DRLM push (Device Registration and List Module).
Select the link "Modify, 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 continue button.
You will be asked to place the activity associated with the device. Yous volition also exist asked to place the proprietary names.
Certify that all information is correct and click on the submit button.

Deactivating

Log on to FDA Industry Folio (FURLS) at https://www.admission.fda.gov/oaa/ with the account ID and password that you previously used to access the establishment 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 listing and click on the deactivation button.
Certify that you lot want to deactivate the list and click on the submit 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 every bit:

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

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 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 not-exempt listings belonging to the owner/operator that must be replaced

Official Correspondent

An official contributor is defined as:

The person designated past the owner/ operator of an establishment responsible for the annual registration of the establishment and the device list. The official contributor besides 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 listing information for each establishment to which he/she is assigned.

The official correspondent tin:

Create new registrations and listings
Make changes, updates and cancellations to registrations and listings that accept been assigned to them
Add their establishment(south) to listings previously entered for the owner/operator
View registration and listing data for the establishments which have been created by or assigned to them

Updating Possessor/Operator and Official Correspondent Account Information

To update the possessor/operator's account information:

Log into FURLS using the owner/operator account id and countersign.
Click on "Edit Profile."
Select the radio button next to "Business relationship." If you are both the owner/operator and official correspondent for the facility, then you will only see one "Business relationship" when you click on "Edit Profile." If you accept designated a person to be the official correspondent for the facility, then you will see "Business relationship" and "Sub-Account" when you click on "Edit Contour."
Click on "Modify."
Make whatever necessary changes to the account and click "Submit". Any changes you brand to the owner/operator account will be reflected in the Possessor/Operator Data for the facility.

To update the official correspondent's account information:

The owner/operator must log into FURLS using the owner/operator account id and password.
Click on "Edit Profile."
Select the radio button next to "Sub-Account" to modify the official contributor's information.
Click on "Modify."
Make any necessary changes to the account and click "Submit". The changes yous make will automatically be reflected in the official correspondent's data 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 data of the official contributor.
Click on "Continue."
Review the information and click on "Submit."

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

Click on "Device Registration and Listing."
From the master menu, select "Change Official Correspondent for a Facility" and click "Proceed."
Check the box side by side to the facility that you lot want to change the official correspondent for and click "Continue."
Select the box next 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 Listing information 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://world wide web.access.fda.gov/oaa/) using your FURLS account ID and countersign.
If you already have an account ID and countersign, DO NOT CREATE A NEW ACCOUNT. Creating a new account will forestall you from accessing your current registration.
Select the DRLM button (Device Registration and Listing Module).
Select the "Alter Registration" link to update registration information or select the "Change, Cancel or Reactivate Listing" link to update your listing information.
Brand the necessary changes to your registration or listing data.
Review the changes yous have made.
Certify that all the data is right and click on the submit button.
When prompted, enter both the PIN and PCN numbers that you received from the Office of Fiscal Management for your payment of the establishment registration fee. This information must be entered in lodge for FDA to accept 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.
Yous volition receive a confirmation screen. Once you receive the confirmation screen, FDA volition consider you 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 information electronically, please submit your request with a complete explanation of why you cannot submit your information electronically to:

Food and Drug Assistants
CDRH - Office of Compliance
Registration & Listing
10903 New Hampshire Artery
Edifice 66 Room 2621
Silver Bound, MD 20993-0002

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