AdvaMed, the trade association
for medical device companies,
supports reauthorization with
small business improvements
WASHINGTON, D.C. -- In testimony May 16, 2007 before the House Energy & Commerce Health Subcommittee, AdvaMed Board Member and Boston Scientific Corporation Chief Operating Officer Paul LaViolette strongly supported reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).
"The reauthorization agreement negotiated by FDA and the medical technology industry puts patient safety first by providing FDA's device center with a sound financial framework to facilitate the timely and effective review of new medical technologies.
"Reauthorizing MDUFMA will enable FDA to improve its performance while creating a stable and predictable fee structure that benefits both the Agency and the medical technology industry. This legislation also contains significant program improvements for small businesses, the lifeblood of much innovation within our industry.
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"The MDUFMA reauthorization is good for patients and for the public health. The House should act promptly to join the Senate in passing the legislation so that a bill can be sent to the President prior to the user fee program's sunset on September 30."
A copy of LaViolette's testimony can be found on AdvaMed's Web site at
www.advamed.org/publicdocs/5-16-07_testimony.pdf.
Note: Medical Device User Fee and Modernization Act would expire on September 30, 2007 if not reauthorized. The reauthorization is now in The House Energy and Commerce Subcommittee on Health. "Single-use" medical devices were a hot topic of meetings in which legislators opposed the use of reprocessed devices. Subcommittee Chair Frank Pallone (D-N.J) plans to introduce legislation restricting their use. A post-market report on the safety of medical devices is not yet available and in review by HHS. Full details about the act are available at
http://www.fda.gov/cdrh/mdufma/.
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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies.
