[Congressional Record (Bound Edition), Volume 148 (2002), Part 15]
[Extensions of Remarks]
[Page 20585]
[From the U.S. Government Publishing Office, www.gpo.gov]




         MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002

                                 ______
                                 

                               speech of

                          HON. MARK E. SOUDER

                               of indiana

                    in the house of representatives

                        Monday, October 7, 2002

  Mr. SOUDER. Mr. Speaker, yesterday, the House passed H.R. 3580, the 
Medical Device User Fee and Modernization Act of 2002.
  Kosciusko County in Northern Indiana is one of the nation's largest 
centers of the medical device industry. I have visited many of the 
medical device manufacturers in my home state, and continue to be 
amazed with the marvels that these companies produce every day. 
Injuries and illnesses that only a decade ago would have been 
debilitating are now curable, thanks in no small part to the ingenuity 
and innovation of companies that produce medical devices.
  H.R. 3580 is a win for both medical device producers and for 
consumers. It streamlines the process by which medical devices will be 
approved by the Food and Drug Administration by establishing a new user 
fee program similar to the one that exists for pharmaceuticals and 
biologics. By doing so, it helps medical device producers get their 
products to the marketplace more quickly, making them available to 
those who need them. The legislation also establishes a new Office of 
Combination Products at the FDA so that producers of combination drugs 
and medical devices do not have to be approved by two separate 
agencies.
  Even more impressive is that medical device consumers are not being 
forced to pay for the creation of a new, faster approval system for 
medical devices. Under this legislation, the companies themselves will 
fund the expedited process.
  It is important to note that this expedited procedure will not 
sacrifice thoroughness for speed. This legislation carefully spells out 
strict standards to ensure the absolute highest level of safety.
  On behalf of medical device manufacturers in Warsaw, Indiana as well 
as those across the nation who benefit from their products, I am 
pleased to support this bill, and urge its passage.

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