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FY 2009 Activities and Accomplishments

FY 2009 MDUFA Performance Report Table of Contents

In addition to reviews completed on submissions during FY 2009, FDA applied an interactive review program, consulted with its stakeholders, and focused on reviewer training. During FY 2009, key activities and accomplishments included:  

  • FY 2008 and FY 2009 cohort performance: As of September 30, 2009, all workload cohorts for FY 2008 and FY 2009 had decisions pending with the exception of premarket approval application (PMA) modules for FY 2008. FDA did not meet the Tier 1 and Tier 2 performance goals for PMA modules in FY 2008. Preliminary performance results for the FY 2008 and FY 2009 cohorts indicate 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.[5] These preliminary performance results may change as additional FDA decisions are made and actions are taken on the FY 2008 and FY 2009 cohorts.
  • Guidance development: FDA developed several guidance documents during FY 2009 including:
    • Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This guidance was required by section 228 of FDAAA.
    • Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria. This guidance was required by section 228 of FDAAA.
    • Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision.
    • Draft Guidance for Industry and FDA Staff - Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
    • Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Tissue Expander.
    • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document - Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.
    • Guidance for Industry - Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide.
    • Draft Guidance for Industry and FDA Staff - Investigational Device Exemption (IDE) Guidance for Retinal Prostheses.
    • Guidance for Industry and FDA Staff - Procedures for Handling Post-Approval Studies Imposed by PMA Order.

The FDA Internet locations for these guidances are located in Appendix B.

  • Stakeholder communication: During FY 2009, FDA held quarterly meetings with stakeholders to report on FDA’s performance under MDUFMA I and for the first 2 years (FY 2008 and FY 2009) under MDUFA II.

[5] A cohort remains open as long as there are submissions for which FDA has not yet made a decision. Until all submissions within a cohort receive a final decision or are pending past the goal date, FDA will continue to update reported performance.

Next page: Report on Final MDUFMA I Performance