; (D) based on a fair evaluation of all material facts, the applicant’s proposed labeling and advertising is not false or misleading in any particular; (E) the application does not contain a false statement of material fact; (F) there is a showing that the representative in vitro clinical test or tests— (i) meets the applicable standard for approval; and (ii) reasonably represent the range of procedures for analytical validation and clinical validation included in the application, as applicable; and (G) the applicant permits authorized employees of the Food and Drug Administration or persons accredited under this Act an opportunity to inspect at a reasonable time and in a reasonable manner the facilities and all pertinent equipment, finished and unfinished materials, containers, and labeling therein, including all things (including records, files, papers, and controls) bearing on whether an in vitro clinical test is adulterated, misbranded, or otherwise in violation of this Act, and permits such authorized employees or persons accredited under this Act to view and to copy and verify all records pertinent to the application and the in vitro clinical test. (4) Review of denials An applicant whose application has been denied may, by petition filed on or before the date that is 30 calendar days after the date upon which such applicant receives notice of such denial, obtain review thereof in accordance with section 587O. (g) Duration; subsequent submissions (1) Order duration A technology certification order shall remain in effect until the earlier of— (A) the expiration of such technology certification order under paragraph (2)