; criteria The guidance under this paragraph shall include specification of— (i) evaluative criteria to be used by an accredited person to assess and, as applicable, certify a requestor’s quality system under this section with respect to in-scope devices; and (ii) criteria for accredited persons to apply for a waiver of, and exemptions from, the criteria under clause (i). (C) Timeframe for issuing guidance The Secretary shall issue under this paragraph— (i) draft guidance not later than 12 months after the enactment of the FDA Regulatory Efficiency Act ; and (ii) final guidance not later than 12 months after issuance of the draft guidance under clause (i). (b) Use of third-Party assessment (1) Assessment summary; certification (A) Submission of assessment to secretary An accredited person who assesses a requestor’s quality system under subsection (a) shall submit to the Secretary a summary of the assessment— (i) within 30 days of the assessment; and (ii) which shall include (as applicable)— (I) the accredited person’s certification that the requestor has satisfied the criteria specified in the guidance issued under subsection (a)(5) for quality system certification with respect to the in-scope devices at issue; and (II) any waivers or exemptions from such criteria applied by the accredited person. (B) Treatment of assessments Subject to action by the Secretary under subparagraph (C), with respect to assessments which include a certification under this section— (i) the Secretary’s review of the assessment summary shall be deemed complete on the day that is 30 days after the date on which the Secretary receives the summary under subparagraph (A)