FDA > CDRH > Registration & Listing > Fees & Payments

Fees & Payments

• Fees
• How to Pay
• Payment Types
• Payments by Wire Transfer

Fees

Congress authorized FDA to collect an annual establishment registration fee for device establishment registrations submitted to the FDA after September 30th, 2007.

A detailed list of all those establishment types that have to pay the registration fee can be found here.

For FY 2009 the fee is: $1,851

Congress has established a schedule of registration fees for fiscal years as follows:

There are no reductions in annual establishment registration fees for small businesses or any other group

How to Pay

If you are required to pay the establishment registration user fee (See Who Must Register, List & Pay the Fee), you must first visit the Device Facility User Fee website to pay the user fee. Once you make payment and receive confirmation numbers for your payment (PIN/PCN), you can proceed to the FURLS website to complete your registration and listing requirements. Additional information can be found in this document.

The fee must be paid and you must receive confirmation that your payment has been processed before you can submit your annual establishment registration information electronically or your registration will not be considered complete.

Payment Types

Follow the instructions on the screen at the Device Facility User Fee website to make your payment. Be sure to allow for enough time for your payment to be received and recorded. FDA will accept the following for payment:

• Electronic Payments (such as credit cards or ACH electronic checks).
• Paper check drawn on a U.S. bank in U.S. currency that is mailed in to FDA (see Payments by Mailing in a Check).

Your registration is not complete until FDA notifies you that all requirements have been met.

Electronic payment

FDA now allows on-line payment by credit card and ACH (Automated Clearing House) electronic checks. Follow the on screen instructions to make payment. Confirmation of payment made by credit card or electronic check can be received in as little as 24 hours.

Payments by Mailing in a Check

If you are paying by mailing in a check to the lock box you must first visit the Device Facility User Fee website to place an order for the establishment registration user fee. Once you place and print your order, you will receive a Payment Identification Number (PIN). Please note the following instructions:

• Funds must be in U.S. currency
• Check made payable to Food and Drug Administration (must be in U.S. dollars and drawn on a U.S. Bank)
• Write the FDA post office box number ( PO Box 70961) on the check
• Write the Payment Identification Number (PIN) on your check
• Include a copy of your order with your check

When your payment has been received and processed you will be notified by email. Conformation of payment by mailing in a check can take up to seven business days. The email will include directions to return to the Device Facility User Fee website to obtain the Payment Confirmation Number (PCN) for your order. You will need the PIN and PCN in order to complete your annual registration in FURLS.

Mailing instructions:

• If your check is going to be sent without using a courier, please mail it to the following address:

Food and Drug Administration
P.O. Box 70961
Charlotte, NC 28272-0961

Please note: This is different than the address for payments of application and annual report fees and is to be used only for payment of annual establishment registration fees.

• If your check is going to be sent by a courier that requests a street address, the courier can deliver the checks to:

Wachovia Bank
Attn: Food and Drug Administration Lockbox 70961
1525 West WT Harris Blvd., Room NC0810
Charlotte, NC 28262

Please note: This Wachovia Bank address is for courier delivery only; do not send mail to this address.

• The tax identification number of the Food and Drug Administration is 53-0196965.
   
• Please write a separate check for each order.

Payments by Wire Transfer

Foreign firms who cannot pay for the device establishment registration fee by credit card, electronic check or a check drawn on a US bank must pay by wire transfer to receive their Payment Confirmation Number (PCN). After generating their Payment Identification Number (PIN), they can contact the User Fee Help Desk by email at userfees@fda.gov for wire transfer instructions.

Updated October 3, 2008