Medical Device User Fee Amendment

The Medical Device User Fee Amendments (MDUFA) are laws that allow the U.S. Food and Drug Administration (FDA) to collect fees from medical device manufacturers when they submit products for review. These fees help speed up the approval process, meaning new devices can be brought to market more quickly. The program aims to enhance the FDA's resources for reviewing medical devices, ensuring they are safe and effective while also meeting the needs of patients and healthcare providers. MDUFA is periodically reauthorized to reflect changes in technology and the medical landscape.