Notice of Medical Device User Fee Rates for Fiscal Year 2011

FDA has announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011 through a notice in the federal register dated Aug 3, 2010. These fees apply from October 1, 2010, through September 30, 2011. To avoid delay in the review of application, one should pay the fee before or at the time they submit their application to FDA. It also provides information on how the fees for FY 2011 were determined, the payment procedures that needs to be followed, and how one may qualify for reduced small business fees. The fee one must pay is the fee that is in effect on the later of the date that their application is received by FDA or the date on which their fee payment is received.

It will now cost more for the medical industry. The cost of 510(k)s, 513(g)s and the annual registrations is going up.