FDA Pledges Support, Industry Urges Full Appropriations for CDRH

Originally Published MX July/August 2003

BUSINESS NEWS

Concern for the success of the device industry user fee program was greatly in evidence at the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington, DC), which took place in early June.

In his first appearance before the group, FDA Commissioner Mark B. McClellan, MD, PhD, described the Medical Device User Fee and Modernization Act of 2002 as "an essential tool for advancing medical technology." Acknowledging that the government has not fully funded the program, McClellan said, "I know you are worried about the shortfall, but we intend to work hard with you and Congress to find the funds that will enable us to do the job."

The user fee act stipulated that Congress would appropriate $75 million over a five-year period while user fees from device manufacturers were expected to generate $175 million. The legislation was intended to speed regulatory review of new and advanced medical technology.