Medical Device User Fee Act (MDUFA III)
In 2002, Congress authorized the Food & Drug Administration to charge a fee to medical device sponsors to assist with the costs of reviewing applications for marketing medical devices. This was achieved in the Medical Device User Fee and Modernization Act (MDUFMA). Revenue raised from the fee program is used to provide FDA with the resources it needs to process and review applications for the marketing of medical devices. Building on the success of user fee program for prescription drug review, this parallel expansion in FDA’s capacity to review new medical devices has also led to a decrease in the time required to review applications but without compromising FDA's commitment to protect the public. Learn more about MDUFA.
View a power point presentation Diane Dorman presented at a 2010 FDA public hearing on the Medical Device User Fee Program.