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FY 2009 Device User Fees Posted

08/01/2008

Federal Register Notice: FDA is publishing the fee rates and payment procedures for medical device user fees for fiscal year 2009. These fees apply from 10/1 through 9/30/09. The standard fee or “base fee” for a premarket application including a biologic application received by FDA during FY 2009 is $200,725. The registration fee for FY 2009 is $1,851.
Other fees are as follows: for a panel-track supplement, 75% of the base fee;
for a 180-day supplement, 15% of the base fee;
for a real-time supplement, 7% of the base fee;
for a 30-day notice, 1.6% of the base fee;
for a 510(k) premarket notification, 1.84% of the base fee;
for a 513(g) request for classification information, 1.35% of the base fee;
and for an annual fee for periodic reporting concerning a Class 3 device, 3.5of the base fee.
For all submissions other than a 510(k) premarket notification, a 30-day notice, and a 513(g) request for classification information, the small business fee is 25% of the standard (full) fee. For a 510(k) premarket notification submission, a 30-day notice, and a 513(g) request for classification information, the small business fee is 50% of the standard (full) fee. There is no small business rate for the annual establishment registration fee; all establishments pay the same fee. To view this notice, click here.

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