[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 485 Introduced in House (IH)]







104th CONGRESS
  1st Session
                                H. R. 485

           To expand the authority for the export of devices.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 11, 1995

  Mr. Kim (for himself, Mr. Moorhead, Mr. Royce, and Mrs. Seastrand) 
 introduced the following bill; which was referred to the Committee on 
Commerce and, in addition, to the Committee on International Relations, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of 
                        the committee concerned

_______________________________________________________________________

                                 A BILL


 
           To expand the authority for the export of devices.

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

SECTION 1. AUTHORITY.

    (a) In General.--In the administration of section 801(e)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(2)), on the 
basis of either of the following notices with respect to a medical 
device the Secretary of Health and Human Services shall make the 
determination in that section that the exportation of such medical 
device is not contrary to public health and safety and has the approval 
of the country to which it is intended for export:
            (1) Notice by the exporting company of approval for 
        marketing or for investigational use of the medical device in 
        the European Community (such approval for marketing referred to 
        as the ``CE'' mark).
            (2) Notice by the exporting company of approval for 
        marketing or investigational use of the medical device by the 
        Ministry of Health and Welfare of Japan or by another 
        appropriate body in the government of Japan.
In the case of a medical device approved only for investigational use, 
this subsection shall not apply unless the initial destination country 
has also specifically approved such medical device for investigational 
use.
    (b) Application.--Subsection (a) does not apply to any medical 
device which has been banned by the Secretary of Health and Human 
Services under section 516 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360f).
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