; and (B) the Secretary has not issued a notification to the developer under paragraph (2) before such time has elapsed. (2) Notification from Secretary The Secretary shall issue a notification to the developer that such test may not be introduced into interstate commerce under such order if the Secretary determines that— (A) such test— (i) does not meet the definition of a moderate-risk test under section 587; (ii) is not eligible to be introduced into interstate commerce under any of subparagraphs (A) through (E) of subsection (a)(1); or (iii) is not eligible to be introduced into interstate commerce under the referenced technology certification order issued by the Secretary because it is not within the scope of the technology certification order under subsection (b)(2); or (B) based on the information included in the notification submitted by the developer pursuant to this subsection, there is insufficient information for the Secretary to make the determinations described in clauses (i), (ii), and (iii) of subparagraph (A). 587E. Mitigating measures (a) Establishment of mitigating measures (1) Establishing, changing, or withdrawing (A) Establishment The Secretary may establish and require, on the basis of evidence, mitigating measures for any in vitro clinical test or category of in vitro clinical tests with the same indications for use that is introduced or delivered for introduction into interstate commerce after the Secretary establishes any such mitigating measures. (B) Methods of establishment The Secretary may establish mitigating measures— (i) under the process set forth in subparagraph (D); (ii) as provided under section 587F; or (iii) through a premarket approval or technology certification order, which may establish mitigating measures for an individual in vitro clinical test or a category of in vitro clinical tests. (C) Methods of change or withdrawal The Secretary may change or withdraw mitigating measures— (i) under the process set forth in subparagraph (D)