FDA > CDRH > Registration & Listing > Fees & Payments

Fees & Payments

• Fees
• Payments by Check
• 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.

The following types of establishments are required to pay the annual establishment registration fee:

• Device manufacturers
• Contract sterilizers (establishments that sterilize a device for a specification developer or any other person) that put the device into commercial distribution
• Contract manufacturers (establishments that make a device for specification developer or any other person) that put the device into commercial distribution
• Single-use device reprocessors
• Specification developers.

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

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.

The fee must be paid after submitting your annual establishment registration information electronically or your registration will not be considered complete. Follow the instructions on the screen to make your payment. Be sure to allow for enough time for your payment to be received and recorded. This process can take up to two weeks. Your registration is not complete until FDA notifies you that all requirements have been met.

Payments by Check

If you are paying by check to the Lock box, 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 Invoice number on your check
• Include a copy of your invoice with your check

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 establishment.

Payments by Wire Transfer

When making a wire transfer, please include the exact transfer fee charged by your bank in addition to the $1,706.00 USD fee.

If you are paying by wire transfer, please note the following instructions:

• FDA’s Account number: 75060099
  
• Routing Number: 021030004
  
• Reference: Your Invoice Number
  
• The bank address is:
  
  US Dept of Treasury
  TREAS NYC
  33 Liberty St
  New York, NY 10045
  
• FedWire funds are payable in US dollars only.
  
• Please note: If you are sending your payment and require a SWIFT code, the SWIFT code for the receiving bank is FRNYUS33.
   
• The beneficiary name is: Food and Drug Administration
   
• The beneficiary address is:
  5600 Fishers Lane
  Rockville, MD 20857

Updated February 22, 2008