FDA Announces User Fees for Devicemakers in 2008

The FDA has established its user fee rates for devicemakers in fiscal 2008 under the Medical Device User Fee and Modernization Act (MDUFMA). The fee rates, which went into place Oct. 1, will remain effective through Sept. 30, 2008.

The law reauthorizing MDUFMA includes two new types of fees intended to generate approximately 50 percent of the total fee revenue — an annual establishment registration fee and an annual fee for filing periodic reports on Class III devices. User fees also will be charged for medical device submissions.

Under the act, the fee rate for each type of submission is set at a specified percentage of the standard fee for a premarket application, a product development protocol or a biologics licensing application.

The standard fee for a premarket application received by the FDA during fiscal 2008 is $185,000, the agency said.