MDUFA and its Impact on Medical Device Sector

Abstract

The U.S. Congress passed Medical Device User Fee Act (MDUFA), where FDA is required to assign and collect fees from manufacturers of medical devices to evaluate the functioning and the usage of the device. for the purpose of fastening the analysis of the application of the drug. The Medical Device User Fee Modernization Act was first adopted in 2002. The act focussed on innovative review process and reviewing capabilities of experts. Every five years, MDUFA comes up with reauthorisation. The act was reauthorized in 2007 by reducing the application fee and introducing certain new fees such as the annual product fee and annual establishment fee which helped in pre-market evaluation. Few issues being raised in MDUFA II led the congress to enact an amendment. The next revision of the act made the review process more efficient and interactive with the applicant to meet the timelines. Recent amendment has set up several new performance goals and proposes certain changes to the previous amendments. The device manufacturers are currently in a position to receive regulatory approval in a short time compared to the pre-MDUFA period. MDUFA has helped in improving the patient health by streamlining the FDA’s approval process for application of new medical device, thereby allowing patient’s quicker access to potentially life changing therapies.