CERTIFICATES TO FOREIGN GOVERNMENTS.

SEC. 3304. CERTIFICATES TO FOREIGN GOVERNMENTS. Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended—(1) in subparagraph (E), by striking clause (iii); and (2) by adding at the end the following:“(F)(i) This paragraph applies to requests for certification under this subparagraph of a device manufactured by a device establishment located outside of the United States that is registered under section 510, if the device is listed pursuant to section 510(j), the device has been cleared, approved, or is not required to submit a premarket report pursuant to subsection (l) or (m) of section 510, and the device is imported or offered for import into the United States. “(ii) The Secretary shall issue the certification as described in clause (iii) if the device or devices for which certification is requested under this subparagraph meet the applicable requirements of this Act. “(iii)(I) A certification for a device described in clause (i) shall be subject to the fee described in subparagraph (B). “(II) Notwithstanding subparagraph (C), a certification for a device described in clause (i) shall address and include the same material information as a ‘Certificate to Foreign Government’ and shall have a document title including the words ‘Certificate to Foreign Government’. “(iv) The requirements and procedures of subparagraph (E) shall apply to a denial of a certification under this subparagraph.” .