MDUFA IV

MDUFA IV, or the Fourth Medical Device User Fee Amendments, is an agreement between the FDA and medical device companies to help speed up the review and approval process for new medical devices. By collecting fees from manufacturers, the FDA gains additional resources, allowing for more efficient and timely evaluations to ensure devices are safe and effective for patients. MDUFA IV is part of a cycle that supports innovation while maintaining high safety standards, with goals to reduce review times and improve transparency in the approval process.