Hi,
I was facing today exactly the same problem while trying to register devices of one of my clients. Then I reviewed again the instructions for the new establishment registration (without the establishment number), and just followed the instructions and it worked and I managed to add the proprietary product names!!
I've copied the instructions again -
http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053185.htm
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 you have never previously registered a device establishment, you will need to first create a FURLS account for the owner/operator (See 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 set up your FURLS account ID and password, select the DRLM button (Device Registration and Listing Module).
Select the link "Register a Medical Device Facility" from the DRLM main menu.
If you do not have any existing registrations, you will see a page that asks you 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 not already appear in the list 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 "Register a New Facility."
The Owner/Operator and Official Correspondent information that you entered when you created or updated your FURLS account will be 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 return to Account Management. If the information is correct, select "Continue Registration."
Enter the required information for your facility and select "Continue Registration."
You will be prompted to enter information about the devices that you manufacture, process, 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 United States) must list all manufacturers of the devices they are importing.
For all facilities EXCEPT initial importers:
Create Listings for devices produced or processed at this facility.
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 ONLY be listed AFTER the premarket submission [510(k), PMA, PDP, HDE] is cleared or approved. If this is your only device listing, please do not register your establishment until after your premarket submission is cleared or approved.
If your premarket submission is cleared or approved, you will need to do the following to list your device:
Enter the premarket submission number
Enter the proprietary name(s)
Identify the activities that you perform on or to the device
If your device is exempt from premarket notification/approval, you will need to do the following:
Obtain the product code. You may click here to find your product code.
Leave the premarket submission number blank
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 name(s)
For Initial Importers (facilities that take first title to a device imported into the United States):
On the "Identify Manufacturers" page, click on the "Search & Add Products" button.
Identify the manufacturer by using either its device listing number, establishment registration number, or establishment name and address.
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" button.
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 not prompted for the PIN/PCN numbers, please send an email to
[email protected]. Without entering these numbers, your registration is incomplete.
You will receive a confirmation screen. Once you receive the confirmation screen, FDA will consider you registered.
If you have any changes to your listings, return to the main menu and select Change, Cancel or Reactivate Listings to update your listing information