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  1. FDA-TRACK: Agency-wide Program Performance

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

 

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FDA-TRACK: Medical Devices
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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 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. 

 

Data Dashboards to be added.

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