[Congressional Record Volume 150, Number 31 (Thursday, March 11, 2004)]
[Extensions of Remarks]
[Page E357]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




               MEDICAL DEVICES TECHNICAL CORRECTIONS ACT

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                               speech of

                          HON. EDOLPHUS TOWNS

                              of new york

                    in the house of representatives

                         Tuesday, March 9, 2004

  Mr. TOWNS. Mr. Speaker, the House is to be commended for swift action 
this week on S. 1881, The Medical Device User Fee and Modernization 
Act. This bill removes the barriers that would have prevented the 
program from functioning as intended. I am particularly pleased about 
the provisions concerning third party inspections, which were included 
in the bill.
  The training for the third party inspection program is complete and 
with passage of S. 1881, the program will finally get underway. S. 1881 
also rightly includes an 18-month delay in the implementation of the 
labeling provisions in section 301 of MDUFMA. During this time, 
questions concerning the requisite scope of the labeling requirement 
can be resolved. The agency, industry and the Congress have an interest 
in reaching a solution that permits the identification of the 
manufacturer of some categories of products by the end user, yet 
maintains flexibility for the many other products produced by FDA 
regulated industries. I am certain all interested parties will continue 
to work toward that balanced solution. And I look forward to finalizing 
the labeling provisions in a manner, which meets the concerns of 
industry, consumers and the FDA.

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