[Congressional Record (Bound Edition), Volume 150 (2004), Part 1]
[Extensions of Remarks]
[Page 658]
[From the U.S. Government Publishing Office, www.gpo.gov]




               MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

                                 ______
                                 

                          HON. MARK E. SOUDER

                               of indiana

                    in the house of representatives

                      Wednesday, January 28, 2004

  Mr. SOUDER. Mr. Speaker, I rise today in support of H.R. 3493, the 
Medical Devices Technical Corrections Act of 2003. This bill will help 
ensure medical devices are quickly approved and sent to market as 
intended by the Medical Device User Fee Modernization Act of 2002. In 
particular, the bill will clarify FDA third-party inspection 
requirements to ensure companies can use third-party inspectors for two 
consecutive inspections. Additionally, the legislation will authorize 
HHS to conduct a study to identify barriers to market entry for 
pediatric products, which often help small populations and, therefore, 
are not profitable to manufacturers.
  These clarifications are critical to the medical device industry in 
the United States, which leads the world in the development and 
manufacturing of medical technology. Medical device companies produce 
nearly $78 billion annually and generate nearly 6 percent annual 
growth. The products produced by these companies have a tremendous 
impact on our country's economy by creating great high-paying American 
jobs and consistently generating annual trade surpluses in the billions 
of dollars.
  Advances in medical technology are improving the quality of life for 
people around the world as new and more effective treatments for 
various diseases and medical conditions are developed. New medical 
technology also helps reduce the cost of health care and Medicare as 
health problems are prevented and treated more easily through early 
detection, less invasive procedures and faster recovery times for the 
patient.
  The medical device industry is critical to the economy of Indiana as 
well as the district I represent, Indiana's 3rd district. A large 
majority of the nation's orthopaedic devices are produced in Warsaw, 
Indiana, where DePuy, Zimmer and Biomet, three of the Nation's leading 
companies in orthopaedic devices are located. These companies control 
roughly 40 percent of the global market share of orthopaedic joint 
replacements and generate $4 billion dollars annually in sales. The 
combined economic and societal impacts of these three companies to my 
district and the state are highly significant. I commend the House for 
summarily passing H.R. 3493 and I encourage my colleagues in the other 
body to vote in favor of H.R. 3493, the Medical Devices Technical 
Corrections Act of 2003.

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