Food and Drug Administration FY 2004 Performance Report to the Congress for the Medical Device User Fee and Modernization Act.

摘要

On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was signed into law. MDUFMA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees from manufacturers who submit certain applications to market medical devices. In exchange for this authority, MDUFMA requires that the FDA pursue a comprehensive set of review performance goals and commitments to improve the timeliness and predictability of medical device reviews. FDA has made good progress in implementing MDUFMA and is making satisfactory progress towards achieving the performance goals set under MDUFMA. FDA has worked hard to communicate the new requirements and challenges of MDUFMA to its stakeholders. The Agency has worked with its stakeholders to ensure that the implementation of the new law proceeds smoothly. FDA is confident that the implementation of MDUFMA will result in significant benefits to industry, health care professionals, and, most importantly, patients.