[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4391 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4391

  To establish rules for export certification of devices manufactured 
                     outside of the United States.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 14, 2022

  Mr. Cassidy introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To establish rules for export certification of devices manufactured 
                     outside of the United States.

    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 ``Correcting a Lack of Efficient, 
Adequate, and Reasonable Documentation Act'' or the ``CLEAR 
Documentation Act''.

SEC. 2. CERTIFICATION OF IMPORTED DEVICES.

    Section 801(e)(4)(E) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 384(e)(4)) is amended by striking clause (iii) and inserting 
the following:
    ``(F)(i) The Secretary shall issue a certification under 
subparagraph (A) for a device manufactured by an establishment located 
outside of the United States that is registered under section 510(i), 
if the device--
            ``(I) is listed pursuant to section 510(j);
            ``(II) has been approved under section 515 or cleared under 
        section 510(k), or is not required to submit a premarket report 
        pursuant to subsection (l) or (m) of section 510;
            ``(III) is imported or offered for import into the United 
        States; and
            ``(IV) otherwise meets the requirements of this Act.
    ``(ii)(I) A certification for a device described in clause (i)--
            ``(aa) shall be subject to the fee described in 
        subparagraph (B); and
            ``(bb) notwithstanding subparagraph (C), shall address and 
        include the same material information as a Certificate to 
        Foreign Government, and shall have a document title that 
        includes the words `Certificate to Foreign Government'.
    ``(iii) The requirements and procedures of subparagraph (E) shall 
apply to a denial of a certification under this subparagraph.''.
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