117 S4391 IS: Correcting a Lack of Efficient, Adequate, and Reasonable Documentation Act U.S. Senate 2022-06-14 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS2d SessionS. 4391IN THE SENATE OF THE UNITED STATESJune 14, 2022Mr. Cassidy introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo establish rules for export certification of devices manufactured outside of the United States.

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.

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..