Political Quotes

“Mr. Speaker, H.R. 3493 is a bill that I introduced with the gentlewoman from California (Ms. Eshoo), which seeks to make technical and clarifying amendments to the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). That bill, which was signed into law by President Bush on October 26, 2002, made sweeping changes to the laws that govern medical device approvals to establish new programs and streamline processes to accelerate the availability of medical devices to patients. For example, MDUFMA established a user fee program that will provide substantial new resources to speed up the approval of the medical devices. It streamlined the approval of combination products such as drug-coated stents which are one of the most exciting new areas of technology. It expanded the role of third parties and outside experts to augment the FDA resources to help FDA meet its beneficial manufacturing inspection requirements; and MDUFMA also extended the use of third-party review programs for 1 year so that it expires in conjunction with other device provisions. The legislation before us today amends the Medical Device User Fee Modernization Act to ensure that it is being implemented properly.”