FDA-TRACK: Medical Device User Fee Amendments (MDUFA) Performance Dashboards
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Medical Device Applications and Supplements
Clinical Laboratory Improvement Amendments
Biologics License Applications
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 Performance Dashboards (MDUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated MDUFA Performance Report to Congress for the Medical Device User Fee Amendments (the Report). The MDUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The MDUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2025. The MDUFA Dashboards present final or updated performance in meeting MDUFA goals for FY 2024 and preliminary performance for FY 2025. Final or updated MDUFA performance data for FY 2025 will be presented in the FY 2026 MDUFA Report and referenced in updated versions of the MDUFA Dashboards.
Medical Device Applications and Supplements
The Medical Device Applications and Supplements Dashboard displays current performance relating to the review of:
- Original Premarket Approvals (PMA), Product Development Protocols (PDP), Panel-Track PMA Supplements, and Premarket Reports
- 180-Day PMA Supplements
- Real-Time PMA Supplements
- De Novo Classification Requests
- 510(k) Premarket Notifications
- Pre-Submissions
Clinical Laboratory Improvement Amendments
The Clinical Laboratory Improvement Amendments (CLIA) Dashboard displays current performance relating to the review of:
- CLIA Waivers by Applications
- Dual 510(k) and CLIA Waivers by Applications
Biologics License Applications
The Biologics License Applications (BLA) Dashboard displays current performance relating to the review of:
- Priority Original BLAs
- Standard Original BLAs
- BLA Manufacturing Supplements Requiring Prior Approval
- Priority BLAs Efficacy Supplements
- Standard BLAs Efficacy Supplements
- Class 1 Original BLA and BLA Efficacy Supplement Resubmissions
- Class 2 Original BLA and BLA Efficacy Supplement Resubmissions