FDA-TRACK: Medical Device User Fee Amendments Biologics License Applications

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Medical Device Applications and Supplements

Clinical Laboratory Improvement Amendments

Biologics License Applications

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

• • Current Performance
• • Historical Performance
• • Goals Summary

Relevant Links:

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

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 MDUFA Biologics License Applications Dataset

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Footnotes:

• * Performance is currently preliminary due to pending submissions.