Medical Device User Fee Amendments

The Medical Device User Fee Amendments (MDUFA) are regulations that require medical device companies to pay fees to the U.S. Food and Drug Administration (FDA). These fees help fund the review process for new devices, ensuring they are safe and effective before reaching the market. The goal is to improve review efficiency and product safety, ultimately benefiting patients by bringing innovative devices to healthcare faster and with thorough oversight. MDUFA is periodically renewed and adjusted to support FDA review capabilities while balancing industry and public health interests.