Jack Reed: “I rise to express my reservations with the Medical Device User Fee and Modernization Act of 2002. While the legislation…”

“I rise to express my reservations with the Medical Device User Fee and Modernization Act of 2002. While the legislation offers some improvements to the current medical device approval and regulation process, I have serious concerns about some aspects of the bill and about the process leading to its impending passage in the Senate. User fees will allow the Food and Drug Administration, FDA, to expedite the review and approval of medical devices, resulting in faster patient access to new and potentially lifesaving technologies. Third party inspections similarly have the potential to enhance the agency's ability to ensure that manufacturing sites are meeting FDA quality standards for device production. And regulating the reprocessing of single use devices should be a positive step for the safe use of these devices. All of these elements of the legislation, however, carry significant potential risk. In our attempts to enhance the efficiency of an agency to which we are not able to give adequate appropriations, we run the risk of undermining FDA's scientific and policy authority and its vital public health mission.”