FDA POSTS MEDICAL DEVICE USER FEE RATES FOR FISCAL 2007

The FDA announced Aug. 1 its publication of fee rates and payment procedures for medical device user fees for fiscal 2007. For all applications submitted Oct. 1 through Sept. 30, 2007, fees must be paid at the fiscal 2007 rates when the applications are submitted, the agency said.

All fees are set as a percentage of the full fee for a premarket, or 510(k), application, the standard (full rate) fee for which is set at $281,600, the agency said.

A 180-day supplement is set at 21.5 percent and the fee for a real-time supplement is 7.2 percent of the base fee, the agency said. For all applications other than 510(k) submissions, the small business rate is 38 percent of the standard rate.

To view the document, go to www.fda.gov/OHRMS/DOCKETS/98fr/oc2006169-n000001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/oc2006169-n000001.pdf).