; or (B) could reasonably affect the statement of contraindications, warnings, precautions, and adverse reactions in the proposed labeling. (3) Request for amendment or supplement The Secretary may request that an applicant amend or supplement an application under subsection (c) or (d) with any information necessary for review under this section. (g) 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 (c) 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 (d) is accepted for submission, the Secretary, after considering any applicable report and recommendations pursuant to advisory committees under section 587G, or prior to the establishment of such advisory committees, any recommendations by a classification panel under section 513, 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 intended 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 (c) with respect to an in vitro clinical test if the Secretary finds that there is a reasonable assurance that the applicable standard is met, and— (i) except as provided under subsection (d), the applicant is in compliance with applicable quality requirements in section 587J or as otherwise specified in a condition of approval, or maintains the documentation required to be in compliance with such requirements if the applicant is not required to submit such