FDA increases medical device user fees by 8.5 percent

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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.