CDRH > Device Advice > Premarket Approval > PMA Review Fees

PMA Review Fees

Overview
Fees
Exemptions and Waivers
When to Pay
How/Where to Send Payment
Qualification for Small Business Fees
Guidance Documents

On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 was signed into law. This law authorizes FDA to charge a fee for medical device product reviews. These fees apply to Premarket Approvals (PMAs), Product Development Protocols (PDPs), Biologics Licensing Applications (BLAs for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research), certain supplements, and Premarket Notifcation 510(k)s.

The fee must be paid for the above listed applications, unless the applicant is eligible for a waiver or exemption. Small businesses may qualify for a reduced fee. Payment must be received on or before the time the application is submitted. If the applicant has not paid all fees owed, FDA will consider the application incomplete and will not accept it for filing.

Fees

For fiscal year 2009 (October 1, 2008 through September 30, 2009), the fees for PMA applications are:

* PMA=Premarket Approval; PDP=Product Development Protocol; BLA=Biologics License Application; PMR=Premarket Report (for a reprocessed device)

The applicable fee corresponds with the date of receipt of the submission by FDA. Please note that FDA will consider the application incomplete and will not accept it for filing until the fee is paid in full. That is, the date of receipt is the date that the application has been received AND the fee is paid in full.

Guidance on assessing user fees can be found in "Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products" http://www.fda.gov/cdrh/mdufma/guidance/1201.pdf

FDA will adjust the fees each year to account for inflation, changes in workloads, and other factors. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

Exemptions and Waivers

The following types of applications require no fee.

• Special PMA Supplements-Changes Being Affected
• PMA Manufacturing Site Change Supplements
• Humanitarian Device Exemption (HDE)
• BLA for a product licensed for further manufacturing use only.

The following exemptions or waivers apply.

When to Pay

Payment must be received at or before the time the application is submitted. If the applicant has not paid all fees owed, FDA will consider the application incomplete and will not accept it for filing.

How/Where to Send Payment

Submit the information and payment in the following order

1. If you believe you qualify as a Small Business and would like to qualify for reduced fees, submit a Small Business Qualification Certification. If you qualify, you will receive a Small Business Decision number. You must provide your Small Business Decision number on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
2. Complete the Medical Device User Fee Cover Sheet and send a completed copy with your payment.
3. Submit your PMA or PMA Supplement and include a copy of the Medical Device User Fee Cover Sheet with your submission.

Complete the Medical Device User Fee Cover Sheet

You should complete the Medical Device User Fee Cover Sheet (Form FDA-3601) online. The Medical Device User Fee Cover Sheet and instructions are available at http://www.fda.gov/oc/mdufma/coversheet.html

You will need to register to create a Medical Device User Fee Cover Sheet. Please note that the User Fee Cover Sheet website was enhanced on March 1, 2005. Even if you have registered in the User Fee Cover Sheet system previously to March 1, 2005, you will need to follow the instructions as a "New User."

You will need one of the following pieces of information to complete the registration process.

Additionally, you will need to identify a Principal Point of Contact (PPOC) in your organization who will be responsible for validating users for security purposes.

After you have registered and have created a user name and password, you will receive a confirmation email. You may then access the cover sheet creation page. A unique user fee Payment Identification Number will be generated on your cover sheet upon completion. You will need three copies of your completed User Fee Cover Sheet: one copy for your payment, one copy for your PMA application, and one copy for your records.

Frequently Asked Questions addresses common questions regarding the Medical Device User Fee Cover Sheet.

Submit Your Payment

Send a printed copy of your User Fee Cover Sheet with your payment. Be sure to include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on your check, bank draft, or U.S. Postal Money Order. The review fee may be submitted by mail, courier, or wire transfer. Send your payment to:

By Mail:
Food and Drug Administration
P.O. Box 956733
St. Louis, MO 63195-6733

By Courier:
If the check is sent by a courier, the courier may deliver the checks to:

US Bank
Attn: Government Lockbox 956733
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only. Contact the US Bank at (314) 418-4821 if you have any questions concerning courier delivery.)

By Wire Transfer:

If using a wire transfer, you may send your payment using the following information. Please note that you are responsible for paying all wire transfer fees. FDA has found that wire transfer can delay proper crediting of your payment and may delay the start of your review.

Account Name: Food and Drug Administration
Account Number: 152302010631
Routing Number: 081000210
Swift Number: USBKUS44IMT

Also include your user fee Payment Identification Number from your Medical Device User Fee Cover sheet when you send payment by wire transfer.

Note: Contact US Bank at 314-418-4821 if you have a question about how to send payment by wire transfer. Your bank or financial institution may assess a fee for sending a wire transfer.

If needed for accounting purposes, FDA's tax identification number is 53-0196965.

Fees should arrive at the bank at least 1 day before the application arrives at FDA. FDA recommends that you send the payment to the bank 4-5 business days before the application arrives at FDA so there is no delay in starting the review of your application. FDA records as the application receipt date the latter of the following:

1. The date the application was received by FDA; or
2. The date US Bank notifies FDA that payment has been received.

US Bank is required to notify FDA within 1-working day, using the Payment Identification Number.

Qualification for Small Business Fees

In FY 2008 (October 1, 2007 through September 30, 2008), firms with annual gross sales and revenues of $100 million or less, including gross sales and revenues of all affiliates, partners, and parent firms, may qualify for lower rates for PMAs, premarket reports, and supplements. The fee is waived for the first premarket application from firms with <$30 million gross receipts or sales .

An affliliate is defined by §737(8) of the FD&C Act: An affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly,

1. one business entity controls, or has the power to control, the other business entity; or
2. a third party controls, or has power to control, both of the business entities.

To qualify, you must submit the MDUFMA Small Business Qualification Certification (Form FDA 3602). In addition, certified copies of you firm's Federal Income Tax Return for the most recent taxable year, including certified copies of the income tax returns of all affiliates, partners, and parent firms must be provided.

The following guidance and form should be used.

FY2009 MDUFMA Small Business Qualification Worksheet and Certification

The Certification should be sent to:

MDUFMA Small Business Qualification (HFZ-222)
Division of Small Manufacturers, International and Consumer Assistance
1350 Piccard Dr.
Rockville, MD 20850

FDA will review the Certification within 60 days and send its decision that you are, or are not, a small business eligible for reduced or waived fees. If your firm qualifies as a small business, the decision letter will include a Small Busines Decision number. The Small Business Decision number is used on the Medical Device User Fee Cover Sheet (Form FDA 3601) to demonstrate that your firm is entitled to a reduced or waived fee. If you submit a reduced fee to FDA without a Small Business Decision number, the submission will not be accepted for filing.

The small business status expires at the end of each fiscal year (September 30th). A new MDUFMA Small Business Qualification Certification must be submitted each year to qualify as a small business.

Questions concerning Small Business Qualification should be directed to Division of Small Manufacturers, International and Consumer Assistance at 240-276-3150 (800-638-2041) or dsmica@cdrh.fda.gov

Guidance Documents

Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products

Bundling Multiple Devices or Multiple Indications in a Single Submission

User Fees and Refunds for Premarket Approval Applications

Additional information and guidance on medical device user fees is available on the CDRH user fee website.

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Updated January 22, 2008

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