November 15, 2007
Why has Food and Drug Administration (FDA) started to charge some establishments a registration fee? New section 738(a)(3) of the Federal Food, Drug, and Cosmetic Act requires “each establishment subject to a registration fee” to pay a fee for “each initial or annual registration under section 510 beginning with its registration for fiscal year 2008.” The fee is “due once each fiscal year, upon the initial registration of the establishment or upon the annual registration under section 510.”
This requirement went into effect on September 27, 2007, when the President signed the “Food and Drug Administration Amendments Act of 2007” (FDAAA) and the act became law. Among other important provisions, FDAAA reauthorizes medical device user fees for fiscal years 2008 through 2012. The reauthorization seeks to balance the needs and interests of the medical device industry by changing the fee structure used to provide FDA the resources it needs to meet performance goals and other objectives negotiated among FDA, the medical device industry, and Congress. Under prior law, FDA derived medical device user fees from a single source: medical device applications. This meant that any increase in user fee revenues could only come from increased application fees. Consequently, from FY 2003 to FY 2007, the standard fee for a premarket application increased by 83%, from $154,000 to $281,600, and the standard fee for a 510(k) premarket notification increased by 90%, from $2,187 to $4,158; other application fees showed similar sharp increases. This rate of increase, if it continued, would have slowed the introduction of important new medical devices, and it is possible that useful devices would never reach health care practitioners and patients. Congress determined that it was preferable to adopt an approach that includes a mix of application fees and annual fees, and FDAAA provides that new approach. By including a modest establishment registration fee, FDAAA provides a broader, more stable revenue base and allows a significant reduction in all existing application fees (for example, the standard fee for an FY 2008 PMA submission is $185,000 — $96,600 less than the fee for an FY 2007 submission) and increased small business fee discounts (for example, a small business will now pay only 25% of the standard fee for a PMA, and only 50% of the standard fee for a 510(k) premarket notification).
What is the establishment registration fee for FY 2008? The amount FDA must assess for each establishment registration fee is specified in section 738(b) of the Federal Food, Drug, and Cosmetic Act. The fee for each FY 2008 establishment registration is $1,706.
Who must pay the establishment registration fee? You must pay the registration fee if your establishment is a manufacturer, single-use device reprocessor, or specification developer, as defined by section 737(13) of the Federal Food, Drug, and Cosmetic Act. Section 737(13) provides that an establishment subject to a registration fee is “an establishment that is required to register with the Secretary under section 510 and is one of the following types of establishments:
(A) MANUFACTURER.—An establishment that makes by any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person.
(B) SINGLE-USE DEVICE REPROCESSOR.—An establishment that, within the meaning of section 201(ll)(2)(A), performs additional processing and manufacturing operations on a single-use device that has previously been used on a patient.
(C) SPECIFICATION DEVELOPER.—An establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.”
Who is exempt from the establishment registration fee? If your establishment is not a manufacturer, a single-use device reprocessor, or a specification developer, as defined by section 737(13), your establishment is not subject to the registration fee. The only exemption provided by the statute is a narrow exemption for an “establishment operated by a State or Federal governmental entity or an Indian tribe.” However, this exemption is not available if any device manufactured by the establishment “is to be distributed commercially.”
Is there a fee waiver or fee reduction for registration of an establishment operated by a small business? No. The statute does not provide for any fee waiver or reduction, and FDA does not have the authority to waive or reduce any registration fee.
Is there a hardship exemption or waiver if I can’t afford the establishment registration fee? No. The statute does not provide for any fee waiver or reduction, and FDA does not have the authority to waive or reduce any registration fee.
May I pay my establishment registration fee in installments over time? No. Section 738(a)(3)(C) states that your fee payment is “due once each fiscal year, upon the initial registration of the establishment or upon the annual registration under section 510.” FDA cannot accommodate requests to pay part of a fee now, and part later. You must pay the entire amount of the fee in a single payment.
May I register my establishment now, and pay the registration fee later? No. Section 738(a)(3)(C) states that your fee payment is “due . . . upon the initial registration of the establishment or upon the annual registration under section 510.” You must pay the entire amount of the fee at the time you submit your registration information.
What may happen if I don’t pay the registration fee for my establishment? Sections 738(f) and 301(p) describe the consequences if you fail to pay your establishment registration fee when it is due. Under section 738(f)(2), “Registration information submitted . . . by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted . . . until the registration fee . . . for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 510.” The “failure to register in accordance with section 510” is a prohibited act under section 301(p). Under section 502(o), any device manufactured “in an establishment . . . not duly registered under section 510” is deemed to be misbranded. FDA may take enforcement action, including seeking injunctions, civil penalties, or criminal penalties, against firms that do not pay the establishment registration fee.
How do I submit my establishment registration fee? You may submit your establishment registration fee by check or wire transfer. Checks must be in U.S. dollars and drawn on a U.S. bank. As such, most foreign establishments may prefer to use wire transfer.
To pay by check:
- Make checks payable to Food and Drug Administration (funds must be in U.S. dollars and drawn on a U.S. bank)
- Include the FDA post office box number ( PO Box 70961) on the check
- Include your invoice number on the check
- Include a copy of your invoice, if possible, with your check
To mail your check , please mail to:
Food and Drug Administration
P.O. Box 70961
Charlotte, NC 28272-0961Please note: This address is only to be used only for payment of annual establishment registration fees. It is not the address for payment of application and annual report user fees.
To send your check by courier, please deliver to:
Wachovia Bank
Attn: Food and Drug Administration Lockbox 70961
1525 West WT Harris Blvd. , Room NC0810
Charlotte, NC 28262Please note: This Wachovia Bank address is for courier deliveries only;
DO NOT SEND MAIL TO THIS ADDRESS.To pay by wire transfer, please use the following information:
FDA’s Account Number: 75060099
Routing Number: 021030004
Bank: New York Federal Reserve Bank
SWIFT Code (Receiving Bank): FRNYUS33The bank address for wire transfer is:
U.S. Dept. of Treasury
TREAS NYC
33 Liberty St
New York, NY 10045Note :
- Wire transfer funds are payable in US dollars only
- Please reference your invoice number
What is the tax identification number of the FDA? The tax identification number of the Food and Drug Administration is 53-0196965.
May I submit my establishment registration fee using a credit card? No, there is no credit card payment method available to pay an establishment registration fee. FDA, however, is exploring means by which to allow credit card payments and will provide further information when it is available at http://www.fda.gov/cdrh/registration/fees.html.
Where can I find additional information about establishment registration? Information about establishment registration fees and payment can be found on our website at http://www.fda.gov/cdrh/registration/fees.html.
How do I contact FDA for assistance with the electronic registration and listing system? We recommend you contact FDA at either of the email addresses given below for assistance. FDA is available to assist you with account IDs and passwords, error messages, and navigating the electronic system. Your email should include all of your information and describe the assistance you need. You may also leave a voice mail at 240-276-0111 or 240-276-0110. We will be in contact with you within 3 working days.
Email: reglist@cdrh.fda.gov or device.reg@fda.hhs.gov
Can a U.S. Agent assisting a foreign establishment access FDA’s electronic registration and listing system? In October, 2007, FDA provided the owner operator and official correspondent of each registered establishment, the establishment’s account ID and password by mail for the electronic registration and listing system. In order to maintain a secure system, owner operators of foreign establishments should provide their U.S. Agents the information necessary to access to the electronic registration and listing system on their behalf.
Where can I find information about the types of establishments that are required to register, list, and/or pay the establishment registration fee?
FDA has developed a chart of establishment activities and related registration, listing, and fee requirements. Please follow the steps below to access the chart on the FDA website (http://www.fda.gov/cdrh/registration/whomust.html).
Steps to access the chart of establishment activities and related requirements
Updated November 20, 2007
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