The Medical Device User Fee and Modernization Act

(MDUFMA) requires that any sponsor (manufacturer) filing a 510(k) must pay the 510(k) user fee BEFORE submitting the actual application to the Document Mail Clerk at the CDRH.


The Standard Fee for 2012 is $4,049 and the Small Business Fee is $2,024 for filing a 510(k). The sponsor must go to
Premarket Notification [510(k)] Review Fees at the CDRH website.


Once this fee is paid, a receipt entitled: Medical Device User Fee Cover Sheet. A Payment Identification Number will be issued, such as: MD6057626-444444.


We have never had a client who was willing to go through the maze of paperwork to qualifying to save the $2,000 difference. Refer to:
800-638-2041, 301-796-7100, [dsmica@fda.hhs.gov]