Medical Device User Fee Act (MDUFA)

The Medical Device User Fee Act (MDUFA) is a law that requires medical device companies to pay fees to the FDA so they can review new medical devices more efficiently. This funding helps the FDA speed up the approval process for devices like pacemakers or MRI machines, ensuring they are safe and effective for patient use. In return, the FDA commits to reviewing devices within set timeframes. MDUFA aims to support innovation while maintaining rigorous safety standards, benefiting both manufacturers and patients through faster access to reliable medical technology.