How soon will FDA show improvement in medical device reviews?
FDA’s performance under the act is to be measured against goals set forth in the commitment letters from Secretary Thompson. These goals recognize that FDA needs to build infrastructure, hire and train new staff, and take other steps to lay the groundwork for success. The goals require significant, measurable improvements by FY 2005, but FDA will strive to show real improvement more quickly. Sunset date. FDA’s authority to collect fees under MDUFMA expires October 1, 2007. In addition, for fiscal years 2006 and 2007, if Congressional appropriations for the device program for that year do not meet certain levels, FDA may not assess medical device user fees for that year and FDA will not be required to meet performance goals for that year.
