[Congressional Record Volume 140, Number 143 (Wednesday, October 5, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: October 5, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                  MEDICAL DEVICE EXPORT PROMOTION ACT

                                 ______


                              HON. JAY KIM

                              of california

                    in the house of representatives

                       Wednesday, October 5, 1994

  Mr. KIM. Mr. Speaker, I rise today to introduce legislation which 
will create jobs in one of the fastest growing export industries in the 
United States.
  As many of my colleagues know, the medical device industry is one of 
the fastest growing industries in the United States. In fact, according 
to the Department of Commerce, the three fastest growing sectors of 
U.S. industry in 1993 were all in the medical technology field.
  The export success of the American medical device industry is 
phenomenal. At a time when the United States is facing huge trade 
deficits with worldwide, the medical device industry is one of the few 
industries which actually enjoys a trade surplus with our trading 
partners. This surplus reached $4.5 billion in 1993--an 11.1 percent 
increase over 1992.
  In short, the U.S. medical device industry is a clear example of an 
American success story. Unfortunately, unnecessary government 
regulation is putting that success story at risk.
  Under current law, medical device manufacturers who wish to export a 
product to foreign countries are required to get partial FDA approval 
of their products--even if that product is only manufactured for export 
and has already been approved by the country where the product is being 
sold. In other words, the FDA requires companies to incur the cost and 
delay of getting U.S. Government approval of products that are not 
going to be sold in this country and which other countries have already 
agreed to accept.
  As a result of this onerous regulation, many medical device 
manufacturers in this country are finding themselves at a substantial 
competitive disadvantage compared to their overseas competitors. Not 
surprisingly, many of these companies are deciding to move out of this 
country to more reasonable regulatory climates--and taking thousands of 
American jobs with them.
  This legislation would eliminate this unnecessary regulatory burden. 
This bill would direct the Secretary of Health and Human Services--the 
agency which oversees the FDA--to annually prepare a list of countries 
which have adequate medical device approval procedures. Medical device 
manufacturers would then be allowed to export to any of the countries 
on the list without FDA approval, provided that the destination country 
approves the device for sale in its own market. The bill also prohibits 
circumvention of our domestic approval processes by prohibiting 
reimport of exported devices back into the United States.

  In sum, I believe that this legislation would remove a significant 
regulatory burden from a major American export industry. In doing so, 
the bill will encourage the growth of this important industry and will 
save the jobs of hard-working Americans. For these reasons, I urge my 
colleagues to support this legislation.

                               H.R. ----

  Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Medical Device Export 
     Promotion Act of 1994''.

     SEC. 2. DEVICE EXPORTS.

       In the administration of section 801 of the Federal Food, 
     Drug and Cosmetic Act, the Secretary of Health and Human 
     Services shall permit the export of a medical device which--
       (1) is intended for export to a country which as determined 
     by the Secretary has a medical device approval process which 
     provides reasonable assurance of the safety and effectiveness 
     of medical devices,
       (2) has been approved under the laws of the country to 
     which it is intended for export,
       (3) is labeled on the outside of the shipping package that 
     it is intended for export, and
       (4) is not sold or offered for sale in domestic commerce.

     A medical device which is exported under the authority of 
     this Act may not thereafter be imported into the United 
     States unless its importation has been approved by the 
     Secretary of Health and Human Services.

     SEC. 3. REVIEW.

       The Secretary of Health and Human Services shall conduct an 
     annual review of the medical device approval laws of 
     countries not described in section 2(1) to determine if such 
     laws provide reasonable assurance of the safety and 
     effectiveness of medical devices.

                          ____________________