[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 572 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                 S. 572

   To expand the authority for the export of devices, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 16, 1995

   Mr. Coats introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
   To expand the authority for the export of devices, and for other 
                               purposes.

    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 Exportation Act of 
1995''.

SEC. 2 AUTHORITY.

    (a) Exportation of Devices.--
            (1) 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)), the Secretary of Health and Human Services shall 
        make the determination under such section, on the basis of a 
        notice described in paragraph (2) with respect to a medical 
        device, that the exportation of the device is not contrary to 
        public health and safety and has the approval of the country to 
        which the device is intended for export.
            (2) Notice requirement.--A determination made under 
        paragraph (1) shall be based on either of the following 
        notices:
                    (A) Notice to the Secretary by the exporting 
                company of approval for marketing or investigational 
                use of the device in the European Community (such 
                approval for marketing referred to as the ``CE'' mark).
                    (B) Notice to the Secretary by the exporting 
                company of approval for marketing or investigational 
                use of the device by the Ministry of Health and Welfare 
                of Japan or by another appropriate body in the 
                government of Japan.
    (b) Applicability.--
            (1) Investigational use.--In a case of a device approved 
        only for investigational use, subsection (a) shall not apply 
        unless the initial country of destination has also approved the 
        device for investigational use.
            (2) Banned device.--Subsection (a) shall not apply to any 
        device that 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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