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Executive Summary MDUFA FY 2009

FY 2009 MDUFA Performance Report Table of Contents

This report presents FDA’s performance through September 30, 2009 with respect to recent MDUFMA I cohorts (FY 2004 to FY 2007) and initial MDUFA II cohorts (FY 2008 and FY 2009), and is FDA’s seventh annual performance report.

MDUFMA I amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees from manufacturers who submit certain applications and reports to FDA. Under MDUFA II, FDA, industry, and Congress negotiated and agreed to a comprehensive set of review performance goals and commitments that seek to improve the timeliness and predictability of medical device reviews from FY 2008 through FY 2012.

During FY 2009, key activities and accomplishments included:
  • FDA met or exceeded two-thirds (8 of 12) of the decision performance goals for the FY 2004 through FY 2007 cohorts under MDUFMA I. 
  • Based on preliminary performance results, FDA has the potential to meet or exceed over half (7 of 12) of the Tier 1 performance goals and two-thirds (8 of 12) of the Tier 2 performance goals for the FY 2008 and FY 2009 MDUFA II cohorts.[1]
  • FDA issued 12 guidance documents to explain and implement key aspects of the MDUFA II program, including two guidances that meet requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and three guidances that meet requirements of the Department of Health and Human Services (HHS) Secretary’s September 27, 2007, letter to Congress.[2]
  • FDA applied an interactive review program, consulted with its stakeholders, and focused on reviewer training.
  • FDA held quarterly meetings with stakeholders to update them on FDA’s performance under MDUFMA I and MDUFA II.
[1] Tier 1 and Tier 2 performance goals were established under MDUFA II and are defined in this report.
[2] The new goals are outlined in a September 27, 2007, letter from former HHS Secretary Michael O. Leavitt to Congress. For convenience, this report refers to this letter as the HHS Commitment Letter. The complete text of the letter is provided in Appendix A and is available at: September 27, 2007, letter from former HHS Secretary Michael O. Leavitt to Congress

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