FDA increases medical device user fees by 8.5 percent
The FDA  has increased medical device user fee rates by an average of 8.5 percent for fiscal year 2010, according to an Aug. 3 notice in the Federal Register.

The standard fee for a premarket application, including a premarket report and efficacy supplement, will now be $217,877, an 8.5 percent increase over the fiscal year 2009 rate of $200,725.

The fiscal year fees, which take place from Oct. 1 through Sept. 30, 2010, include:
  • Panel-track supplement, $163,340;
  • Real-time supplement, $15,245;
  • 510(k) premarket notification submission, $4,007;
  • 30-day notice, $3.485;
  • 513(g) (21 U.S.C. 360c(g)) request for classification information, $2,940
  • Annual fee for periodic reporting on a class III device, $7,623; and
  • Annual establishment registration fee, $2,008.

If a business has gross receipts or sales of no more than $100 million for the most recent tax year, it can qualify for reduced small business user fee rates ranging from 25 to 50 percent of the standard user fee.