The Medical Imaging & Technology Alliance (MITA) lauded the U.S. House of Representatives for the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA II).
“The reauthorization of MDUFMA helps ensure that the medical imaging technologies so critical to healthcare today will be accessible to patients and providers in a timely, safe and effective manner,” said Andrew Whitman, MITA vice president.
Passed in the House as part of H.R. 2900, the Food and Drug Administration Amendments of 2007, MDUFMA II reauthorizes the collection of medical device user fees for FY2008-FY2012 to be used to improve the time in which new and innovative medical imaging technologies are approved by the FDA. The bill also provides for a reduction in fees for small businesses and enhanced performance goals for the FDA, and contains important provisions impacting third-party inspections. Those provisions would eliminate procedural barriers, remove limits on third-party inspections before FDA inspection, and create greater harmonization with global standards.
In 2002, Congress approved the Medical Device User Fee and Modernization Act, or MDUFMA I, which for the first time established a user fee program for medical devices modeled after the prescription drug user fee program. Because of limited resources at the FDA, MDUFMA I instituted a new revenue stream in the form of a five-year user fee program which imposed a series of fees on device manufacturers based on the types of device applications being submitted.