FDA-TRACK: Medical Device User Fee Amendments (MDUFA) Quarterly Performance Dashboards – De Novo Classification Requests

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Premarket
Approval (PMA)

Alternative Premarket Pathways

Pre-Submission
Activities

• • PMA Original and Panel-Track Supplements
• • PMA 180-Day Supplements
• • PMA Real-Time Supplements

• • 510(k) Notifications
• • De Novo Classification Requests

• • Pre-Submissions – Provide Written Feedback

Relevant Links:

1. • MDUFA V Commitment Letter
2. • MDUFA Amendments
3. • FDA User Fee Reauthorization Act of 2022
4. • FDA-TRACK: MDUFA Annual Performance Reports
5. • FDA-TRACK: MDUFA Annual Performance Dashboards

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.

Download De Novo Classification Requests Dataset

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Footnotes:

•   * FY 2025 and FY 2026 includes preliminary performance as of 12/31/2025.