FDA Announces Recommendations to Reauthorize Medical Device User Fee Program

by Sabrina I. Pacifici on April 16, 2007

Press release: “The U.S. Food and Drug Administration (FDA) today proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II), which, if adopted, would help to ensure that safe and effective medical devices get to patients in a timely manner. FDA is accepting public comments on the proposal for the next 30 days and is holding a public meeting on April 30.”

  • Federal Register notice
  • Fact Sheet: FDA Legislative Package for Next Medical Device User Fee Program
  • Comparison of Quantitative Decision Goals in MDUFMA I and II
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