In the late 1990’s and early 2000’s, the FDA began losing critical resources that were needed to facilitate timely review of medical device applications as well as to provide necessary resources to regularly update guidance documents that are essential for both FDA staff and Medical Device companies. In 2002, the medical device industry and Congress came together to develop the Medical Device User Fee and Modernization Act of 2002. The act was passed:
“in order to provide the Food and Drug Administration (FDA) with the resources necessary to better review medical devices, to enact needed regulatory reforms so that medical device manufacturers can bring their safe and effective devices to the American people at an earlier time, and to ensure that reprocessed medical devices are as safe and effective as original devices”