FDA increases user fees by 8.5 percent

by Olga Deshchenko, DOTmed News Reporter | September 13, 2010
The federal watchdog
announced a hike in user fees
The U.S. Food and Drug Administration announced an 8.5 percent increase in user fees for medical device companies looking to apply for 510(k) or premarket approval starting Oct. 1.

Companies that apply for 510(k) approval will have to pay $4,348 in the upcoming fiscal year, compared to the 2010 standard fee of $4,007. The fees for FDA's 513(g) request for classification will increase from $2,941 to $3,191. Through a 513(g) request, the FDA provides the manufacturer with information about its device classification and protocols for clearance or approval.

The FDA first proposed to raise the user fees in April. The agency will hold a public meeting on the reauthorization of the medical device user fee program tomorrow, although it doesn't expire until 2012.

"User fees for the review of medical device premarket applications, reports, supplements, and premarket notification submissions provided additional resources to make FDA reviews more timely, predictable, and transparent to applicants," according to the agency's public meeting notice.

The agency first began collecting user fees under the Medical Device User Fee and Modernization Act enacted in 2002. It was reauthorized in an updated version of the legislation in 2007.

In 2009, the FDA spent $47.3 million of the $61.8 million it collected in user fees, according to a July financial report to Congress. Approximately 66 percent of the fees were spent on "personnel compensation and benefits for staff," according to the report.

Tomorrow's meeting will consist of a presentation by the FDA and a series of panels that represent different stakeholder interest groups. It will be held in the Washington D.C. metropolitan area.