; and (II) shall specify the scope of the technology certification; or (ii) deny the application, if the Secretary finds (and sets forth the basis of such finding as part of or accompanying such denial) that one or more grounds for granting the application specified in paragraph (3) are not met. (B) Extension The timeline described in subparagraph (A) may be extended by mutual agreement between the Secretary and the applicant. (2) Deficient applications (A) In general If, after receipt of an application under this section, the Secretary determines that any portion of such application is deficient, the Secretary, not later than 60 days after receipt of such application, shall provide to the applicant a description of such deficiencies and identify the information required to resolve such deficiencies. (B) Converting to premarket applications When responding to the deficiency letter, the developer may convert the application for technology certification under subsection (c) into a premarket application under section 587B. (3) Technology certification order The Secretary shall issue an order granting a technology certification under this section if, on the basis of the information submitted to the Secretary as part of the application and any other information with respect to such applicant, the Secretary finds that— (A) there is a showing that in vitro clinical tests within the scope of the technology certification order will meet the applicable standard; (B) the methods used in, and the facilities or controls used for, the development of eligible in vitro clinical tests covered by the proposed scope of the technology certification conform to the applicable requirements of section 587K with respect to— (i) design controls, including related purchasing controls and acceptance activities; (ii) complaint investigation, adverse event reporting, and corrections and removals; and (iii) process validation, as applicable