Gus Bilirakis: “Unfortunately due to an unexpected passing of a close family friend I was unable to speak in person for my strong…”

“Unfortunately due to an unexpected passing of a close family friend I was unable to speak in person for my strong support of H.R. 3580. However, I am very pleased that you brought this legislation forward today and would ask all my colleagues to strongly support, H.R. 3580, the Medical Device User Fee and Modernization Act of 2002. I believe that this important legislation will increase access to breakthrough medical technologies, and improve efficiencies at the Food and Drug Administration (FDA). This legislation, which enjoys broad bi-partisan support, contains three main provisions. First, the legislation authorizes, for the first time, a medical device user fee system. This user fee agreement was negotiated between the Food and Drug Administration (FDA) and industry, and it will provide FDA with the additional resources it needs to speed the review of medical devices. I would note that the user fee structure is two-tiered, and effectively recognizes the needs of small device manufacturers.”