FDAnews Device Daily Bulletin


May 3, 2006

Nearly 70 percent of device manufacturers say the FDA's Medical Device User Fee and Modernization Act of 2002 (MDUFMA) has not improved the predictability or timeliness of device reviews, according to a survey conducted by the Lewin Group for the FDA.

The Lewin Group surveyed 30 device manufacturers about MDUFMA, which authorizes the agency to collect fees from devicemakers to supplement device review appropriations. Those funds are meant to be used to hire additional reviewers to streamline the review process.

Most respondents expressed support for MDUFMA's purpose and goals and commended the approach of balancing faster review time and safety. But they were also skeptical about whether the program is achieving its purpose or has "yielded a return on the investment of industry user fees and other resources devoted to the program."

Some respondents said MDUFMA has not improved predictability and that review times have remained "about the same" compared to pre-MDUFMA experiences. Being able to anticipate how long it takes to get new devices to market is critical to manufacturers, particularly for smaller device firms with limited resources, they said. Monitoring and tracking the FDA's cumulative review time is critical moving forward, and the agency should consider expedited review for novel and "breakthrough" technologies, they added.