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  1. Medical Device User Fee Amendments (MDUFA)

The FDA provides annual and quarterly reports on its progress towards meeting performance goals and commitments set under MDUFMA to its stakeholders and Congress.

The FDA also provides an annual financial report to Congress to help ensure transparency and accountability of its use of the additional resources provided by MDUFMA.

Individuals using assistive technology may not be able to fully access the information contained in these documents. For assistance, please call 1(800) 638-2041 or (301) 796-7100 or send an email to CDRH’s Division of Industry and Consumer Education (DICE). Please include “508 Accommodation” and the title of the document in the subject line of your e-mail.

MDUFA Annual Reports

MDUFA Quarterly Performance Reports

Each report includes the agenda for the quarterly meeting and the quarterly performance data.





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