CLEAR Documentation Act

Bill: 117-s-4391
Sponsor: full_name: Sen. Cassidy, Bill [R-LA]
Introduced: 2022-06-14
Policy area: Foreign Trade and International Finance
Latest action: action_date: 2022-06-14
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2022-06-14
action_desc: Introduced in Senate
text: <p><strong>Correcting a Lack of Efficient, Adequate, and Reasonable Documentation Act or the CLEAR Documentation Act</strong></p> <p>This bill establishes certain rules for the Food and Drug Administration to issue export certifications for medical devices that are manufactured outside of the United States. A certification for a medical device must be subject to a user fee.</p>

tv_txt: II 117th CONGRESS 2d Session S. 4391 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.

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. .