; (ii) the application does not contain a false statement of material fact; (iii) based on a fair evaluation of all material facts, the proposed labeling is truthful and non-misleading and complies with the requirements of section 587K; (iv) except as provided under subsection (d), the applicant permits, if requested, authorized employees of the Food and Drug Administration and persons accredited under section 587P an opportunity— (I) 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 (II) to view and to copy and verify all records pertinent to the application and the in vitro clinical test; (v) the test conforms with any applicable performance standards under section 587Q and any applicable mitigating measures under section 587E; and (vi) all nonclinical laboratory studies and clinical investigations involving human subjects that are described in the application were conducted in a manner that meets the requirements of this section. (B) Conditions of approval An order approving an application pursuant to this paragraph may require conditions of approval for the in vitro clinical test, including conformance with performance standards under section 587Q and restrictions under section 587N. (C) First-of-a-kind test For a first-of-a-kind in vitro clinical test, an order approving an application pursuant to this paragraph— (i) may impose requirements for tests with the same indications for use, including conformance with performance standards under section 587Q and mitigating measures under section 587E, and comply with restrictions under section 587N