; (E) the test developer makes the documentation described under subparagraph (C) available to the Secretary upon request; and (F) the test developer updates the listing information for the test kit or test protocol, as applicable. (d) Amendments to an application An applicant shall amend an application submitted under subsection (a), (b), or (f) if the applicant becomes aware of information that could reasonably affect an evaluation under subsection (e) of whether the approval standard has been met. (e) Action on an application for premarket approval (1) Review (A) Disposition As promptly as possible, but not later than 90 calendar days after an application under subsection (a) is accepted for submission (unless the Secretary determines that an extension is necessary to review one or more major amendments to the application), or not later than 60 calendar days after an application under subsection (b) is accepted for submission or a supplemental application under subsection (f) is accepted for submission, the Secretary, after considering any applicable report and recommendations pursuant to advisory committees under section 587H, shall issue an order approving the application, unless the Secretary finds that the grounds for approval in paragraph (2) are not met. (B) Reliance on proposed labeling In determining whether to approve or deny an application under paragraph (1), the Secretary shall rely on the indications for use included in the proposed labeling, provided that such labeling is not false or misleading based on a fair evaluation of all material facts. (2) Approval of an application (A) In general The Secretary shall approve an application submitted under subsection (a) or (b) with respect to an in vitro clinical test if the Secretary finds that the applicable standard is met, and— (i) the applicant is in compliance with applicable quality requirements in section 587K; (ii) the application does not contain a false statement or misrepresentation of material fact