FDA-TRACK: Medical Device User Fee Amendments (MDUFA) Quarterly Performance Dashboards

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On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022 (FUFRA), which included the reauthorization of the Medical Device User Fee Amendments (MDUFA) for 5 additional years (FY 2023 through FY 2027, referred to as MDUFA V). MDUFA provides FDA with revenue to hire additional reviewers and support staff and upgrade its information technology systems to maximize the efficiency of the application review process for new devices without compromising FDA's high standards for approval.

The Medical Device User Fee Amendments Quarterly Performance Dashboards (MDUFA Quarterly Dashboards) provide a concise, interactive, and visual presentation of data presented in the quarterly MDUFA Performance Reports for the Medical Device User Fee Amendments. The MDUFA Quarterly Dashboards are not intended to replace the quarterly reports and are to be used as a supplemental tool for viewing the data. The MDUFA Quarterly Dashboards reflect performance on submissions received and actions taken as of December 31, 2025 (FY 2026 Q1). The MDUFA Quarterly Dashboards present performance in meeting MDUFA goals for cohorts from FY 2023 through FY 2026 Q1. Updated MDUFA quarterly performance data will be presented in subsequent quarterly reports and reflected in updated versions of the MDUFA Quarterly Dashboards.