Steve Buyer: “the Medical Device User Fee and Modernization Act addresses three crucial interests of the medical device community and…”

“the Medical Device User Fee and Modernization Act addresses three crucial interests of the medical device community and the patients and providers it serves. First, it has been recognized for some time that the Food and Drug Administration is not reviewing medical device applications in a timely fashion. For this to happen, FDA needs adequate resources to have personnel who have the necessary expertise to conduct reviews. This bill would address this matter by imposing user fees on the medical device community for the first time, to provide FDA additional funding for hiring and maintaining a highly skilled workforce and to implement infrastructure improvements. The FDA will also pledge to enhance its performance in reviewing and evaluating device applications. Second, the device community would like to see more utilization of expert third parties in quality assurance of facilities and manufacturing processes and review of applications. This measure will provide flexibility in regard to inspection while retaining FDA's authority in device manufacturing. Finally, the bill addresses concerns over the labeling and reuse of medical devices. On the whole I think this is a balanced bill. The agreement on these provisions was reached after much hard work and it is my view that all parties negotiated in good faith to achieve the best agreement. I am very appreciative of the adoption of several suggestions I have made to ensure that children are well served by this bill.”