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 relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including corrective actions to address deficiencies identified by the Secretary. (iii) Not later than 1 year after date of enactment of this subparagraph, the Secretary shall issue guidance providing for a process to carry out this subparagraph. (G) (i) Subparagraphs (E) and (F) apply to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located in the United States or another country. (ii) The Secretary may charge a fee for the issuance of a certification described in clause (i), and such fee is subject to the conditions and requirements of subparagraph (B).