[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5188 Introduced in House (IH)]

103d CONGRESS
  2d Session
                                H. R. 5188

  To authorize the export of medical devices to countries which have 
                         approved such devices.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 5, 1994

   Mr. Kim introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To authorize the export of medical devices to countries which have 
                         approved such devices.

    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.
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