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MDUFMA First Quarter FY 04 Report (3/31/04) |
Link to presentations: [PowerPoint Version] [Accessible Text Version]
Introduction
The goals of MDUFMA give FDA the necessary start-up time to build infrastructure, hire, and train staff, to be able to meet performance targets that generally become applicable in 2005. As was the case with the Prescription Drug User Fee Act ten years ago, the agency utilized the first year of MDUFMA to set up the User Fee Program and establish necessary systems and procedures.
The long-term goal of MDUFMA is to provide FDA’s medical device program with sufficient resources to ensure that safe and effective new products get to consumers as quickly as possible. Enhanced staffing, increased training, and better infrastructure will help FDA work more interactively and efficiently with submitters to shorten development and review time for life saving medical technologies by 2007.
During Fiscal Year 2004, for example, FDA expects to spend user fees to add more than 100 additional staff, who will be fully trained and fully engaged in the review process. These new staff members will conduct and support medical device reviews, so that the agency can meet the challenging performance goals associated with this program and ultimately help industry speed the development and marketing of safe and effective new products.
MDUFMA established ten statutory deadlines in the first year, and FDA has met all of them. Most of these requirements dealt directly with provisions of the statute other than user fee performance goals. For example, during the first year FDA
FDA also published a number of additional guidances on a variety of the MDUFMA provisions to train staff and help industry understand the agency’s process for implementing MDUFMA, including the various user fee provisions. A complete list of the guidances available, as well as other information about MDUFMA implementation, can be found at www.fda.gov/cdrh/mdufma/index.html.
To provide feedback to the many parties with a stake in the success of MDUFMA, including Members of Congress, FDA has several mechanisms to report on its MDUFMA progress for Fiscal Year 2003.
The performance report being prepared for Congress will show that; while there are some measures that indicate the agency is close to meeting some of the statutory goals reiterated in the MDUFMA goals letter, the goals that emphasize a complete review early in the process will require significant improvement. This is particularly true with respect to breakthrough technologies, or expedited review products, which is the area where the agency has committed to the most significant changes.
Although performance in all areas has not changed dramatically during this start up year, the agency has taken a number of steps that will contribute to its ability to meet the aggressive goals that become effective in 2006 and 2007. In addition to establishing payment, billing, and small business designation procedures for the user fee program, FDA has invested user fee and appropriated dollars in a number of ways that will contribute to the ultimate improvement in the review process in later years. Among other actions, CDRH
FDA’s financial report to Congress (required under MDUFMA) is due by January 2004.
Highlights include:
The following slides are presentations representing the progress MDUFMA has made in various aspects from FY 03 and requirements and the quarterly updates for FY 04.
[PowerPoint Version] [Accessible Text Version]
Updated March 31, 2004
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