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Important Information on the Medical Device User Fee Rates for FY2008

Dear Registered Establishment:

The United States Food and Drug Administration (US FDA) is publishing the fee rates and payment procedures for medical device user fees for fiscal year 2008 (October 1, 2007-September 30, 2008). The Federal Food, Drug, and Cosmetic Act (FD&C), as amended by the Food and Drug Administration Amendments Act (FDAAA) of 2007, reauthorizes FDA to collect user fees for certain medical device applications. These fees apply to Premarket Approvals (PMAs), Product Development Protocols (PDPs), Premarket Reports (PMRs), Biologics Licensing Applications (BLAs for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research), some supplements, and Premarket Notifications [510(k)s]. In addition, FDAAA authorizes FDA to collect fees for applications not currently subject to fees. They are 30-day notices, annual reports, request for classification (513g) and establishment registration.

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 or review. Small businesses may qualify for a waiver or a reduced fee.

Fees for Establishment Registration

FDAAA amends section 510(p) of the act to require electronic submission of registration and listing information. For fiscal year 2008 (October 1, 2007 through September 30, 2008), the fee for registration is the following:

There is no fee for submitting or updating listing information. There are no small business waivers or reduced fees for establishment registration.

Note: Important new information regarding small business relief for FY2008.

In an effort to reduce the burden on small businesses, FDA provides a reduced rate for firms that meet the definition of a small business under FDAAA. The definition of a small business has not changed since 2006, i.e. $100 million or less in gross sales and receipts of all affiliates, partners, and parent firms. Small firms with gross sales of $30 million or less would be eligible to have the fee on their first PMA waived. New for FY08, there is a mechanism for firms based outside the U.S., to qualify for a small business fee reduction.

Fees for Premarket Notification [510(k)s] and Request for Classification [513g]

For fiscal year 2008 (October 1, 2007 through September 30, 2008), the fee for 510(k) review and 513(g) review are the following.

This application fee applies to all 510(k)’s including Traditional, Abbreviated, and Special 510(k)s.

The FY2008 fees apply to applications received on or after October 1, 2007. If the application and payment are received prior to October 1, 2007, applicants should pay the FY07 fee.

Do NOT send payment to FDA with your application. Additional information, including instructions on how and where to send payment and how to qualify as a small business, is available at http://www.fda.gov/cdrh/devadvice/314a.html.

Fees for Premarket Approvals

For fiscal year 2008 (October 1, 2007 through September 30, 2008), the fees for these applications are:

 The FY2008 fees apply to applications received on or after October 1, 2007. If the application and payment are received prior to October 1, 2007, applicants should pay the FY07 fee.

Do NOT send payment to FDA with your application. Additional information, including instructions on how and where to send payment and how to qualify as a small business, is available at http://www.fda.gov/cdrh/devadvice/pma/userfees.html

Fees for FY 2009 and subsequent years will be published in the Federal Register 60 days before the start of each fiscal year.

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) can answer questions concerning the new law and help you find guidance documents and other reference materials. DSMICA can be contacted by phone at 800-638-2041 or 240-276-3150 or by email at DSMICA@FDA.HHS.GOV. Questions regarding products regulated by the Center for Biologics Evaluation and Research should be directed to the Office of Communication, Training and Manufacturers Assistance (OCTMA). OCTMA can be contacted by phone at (301) 827-2000 or (800) 835-4709 or by email at MATT@CBER.FDA.GOV

Further information regarding FY2008 User Fees is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/07-1919.pdf, while additional information about the Medical Device User Fee and Modernization Act II is available at: http://www.fda.gov/cdrh/mdufma/index.html.

Sincerely yours,

John F. Stigi
Director, DSMICA
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Updated October 5, 2007

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