MDUFMA Overview: Preparing FDA for 21st Century Medical Technology

America is experiencing an unprecedented revolution in medical technology. Medical technology companies have doubled their R&D spending over the last decade and the number of patents has increased by 80 percent. As a result, innovation is accelerating at a rapid pace in areas such as medical device miniaturization, gene-based and molecular diagnostics, health information technology, tissue engineering and organ replacement.

This accelerating pace of medical innovation threatens to overwhelm the Food & Drug Administration (FDA), which is charged with reviewing new technologies to ensure they are safe and effective. Despite recent improvements, FDA review times for breakthrough technologies remain more than twice the statutory 180-day deadline. Historically, these delays have been due in large part to resource constraints, which have affected the Agency's ability to hire and retain the necessary scientific expertise. For example, FDA's device review program budget remained essentially flat (in real dollars) throughout the 1990s. From 1995 to 2002, staffing levels fell nearly 10 percent.

Recognizing this trend, Congress and the Bush Administration passed and enacted the landmark Medical Device User Fee and Modernization Act of 2002 (MDUFMA) to ensure FDA had the tools and resources needed to keep pace with 21st Century medical technology innovation. When implemented fully, this historic law will offer patients timelier access to new medical technologies by providing FDA with a stable, consistent revenue source.

MDUFMA highlights:

• MDUFMA established fees for premarket approval applications, supplements and 510(k) submissions. These fees, combined with funds from increased appropriations, are designed to provide FDA's device program with approximately $225 million in additional resources over the next five years (FY2003 - FY 2007).
  
• Congress authorized $75 million in increased appropriations over the five-year life of the user fee program for FDA medical technology review activities. The program is scheduled to sunset after FY 2005 if the appropriations do not materialize.
  
• Medical technology companies will pay user fees totaling $150 million over five years.
  
• Small companies, which have fewer than $30 million in sales, do not pay fees on initial PMAs and pay reduced fees for subsequent PMAs, PMA supplements and 510(k)s.
  
• FDA committed to meeting strict performance goals for medical technology reviews, which will result in an average 25 percent improvement in review times for all submissions. These performance goals include strict goals for each cycle of the review process, with demonstrable improvement in review times required beginning in FY 2005.