FDA-TRACK: Medical Device User Fee Amendments Historical Performance - Medical Device Applications and Supplements

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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 Historical Performance: Medical Device Applications and Supplements Dataset

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Footnotes:

• * Performance is currently preliminary due to pending submissions.
• ** Third Party 510(k)s have a Decision but do not have a Substantive Interaction. As such, Third Party and non-Third Party 510(k)s are included in the Decision data, but only non-Third Party 510(k)s are included in the Substantive Interaction data.
• *** The Performance Workload chart represents the count of submissions either reviewed and acted on or under review during the MDUFA fiscal year. This count may differ from the Review Workload by Submission Type table included in the annual MDUFA Performance Report to Congress.