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”.
Correcting a Lack of Efficient, Adequate, and Reasonable Documentation Act
A BILL
To establish rules for export certification of devices manufactured outside of the United States.
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.”