Federal Register Notice: FDA is publishing the fee rates and payment procedures for medical device user fees for fiscal year 2008. The registration fee is $1,706. The standard fee for a premarket application is $185,000. The fees set by reference to the base are for a panel-track supplement, 75 % of the base fee; for a 180-day supplement, 15%, for a real-time supplement, 7 % of the base fee; for a 30-day notice, 1.6 %; for a 510(k) premarket notification, 1.84 %, for a 513(g) request for classification information, 1.35 %; and for an annual fee for periodic reporting concerning a Class 3 device, 3.5 % of the base fee.
There is no reduction in the registration fee for small businesses. An establishment must pay the annual registration fee if it is any of the following types of establishments: manufacturer, single-use device reprocessor, and specification developer. These fees apply from 10/1 through 9/30/08. To view this notice, click here.