; and (iv) identifies practices for investigators and device establishments to facilitate the continuity of inspections. (B) Not later than 18 months after the date of enactment of this subsection, after notice and opportunity for public comment on the draft guidance described in subparagraph (A), the Secretary shall issue final guidance consistent with this subsection. . 4. Certificates to foreign governments for devices Subsection (e)(4) of section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(e)(4) ) is amended— (1) by adding at the end the following: (E) (i) If the Secretary denies a request for certification with respect to a device pursuant to subparagraph (A)(ii), the Secretary shall provide in writing to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based. (ii) If the denial of a request as described in clause (i) is based on grounds other than an injunction proceeding pursuant to section 302, seizure action pursuant to section 304, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific deficiencies identified. (iii) With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary shall not deny a request for certification with respect to a device pursuant to subparagraph (A)(ii) if the Secretary and the owner, operator, or agent in charge of such establishment have agreed to a plan of correction in response to such report. (F) (i) The Secretary shall provide a process for a person who is denied a certification as described in subparagraph (E)(i) to request a review that conforms to the standards of section 517A(b). (ii) Notwithstanding any previous review conducted pursuant to clause (i), a person who has been denied a certification as described in subparagraph (E)(i) may at any time request a review in order to present new information