Effects of the Medical Device User Fee and Modernization Act on FDA Review Times for Medical Devices

In the United States, the safety and efficacy of medical devices are regulated by the US Food and Drug Administration (FDA), which must successfully navigate a crucial tradeoff between speed and safety in approving applications for new devices. Although a shorter (and potentially less thorough) approval process could benefit patients by resulting in quicker access to potentially life-saving therapies, the potential benefits could be outweighed if a shorter approval process allows more unsafe devices to enter the market. In 2002, Congress passed the Medical Device User Fee and Modernization Act (MDUFA), with the aim of pushing the FDA toward the speed side of the tradeoff. The MDUFA levied large user fees on manufacturers of medical devices in exchange for the promise of shorter review times by the FDA. Whether the Act has resulted in shorter review times is unclear. We conducted a regression analysis using data on FDA review times for devices seeking approval between 1991 and 2012 to address this question. During the pre-MDUFA era (1991–2002), review times for new devices fell by 8% annually for device applications submitted for approval under the more stringent process of premarket approval and fell by 4.5% annually for devices submitted under the less stringent premarket notification, or 501(k), process. These trends continued during the initial MDUFA era (2003–2008), as well as during the initial period after the law's reauthorization (2008–2012). Our results suggest that, for the years studied, the MDUFA was associated with a smaller annual decline in review times and does not appear to have achieved its intended goal of reducing review times for medical devices