; and (II) such in vitro clinical test is being offered by its developer with materially deceptive or fraudulent analytical or clinical claims; (ii) it is reasonably possible that such in vitro clinical test will cause serious adverse health consequences; or (iii) in the case of specimen receptacles, there is sufficient valid scientific evidence indicating that a specimen receptacle did not perform as intended, will not support the analytical validity of tests with which it is used, or as applicable, is not safe for use. (B) Process (i) Request for information If the Secretary has valid scientific evidence indicating that the criteria listed in subparagraph (A) apply to an in vitro clinical test, the Secretary may request that the developer of the test submit information— (I) pertaining to such criteria; and (II) establishing the basis for any claimed exemption from premarket review. (ii) Deadline for submitting information Upon receiving a request for information under clause (i), the developer of an in vitro clinical test shall submit the information within 30 days of such receipt. (iii) Review deadline Upon receiving a submission under clause (ii), the Secretary shall— (I) review the submitted information within 60 calendar days of such receipt; and (II) determine whether the criteria listed in subparagraph (A) apply to the in vitro clinical test. (iv) Premarket review required (I) In general If the Secretary finds that the criteria listed in subparagraph (A) apply to the in vitro clinical test, the developer shall— (aa) promptly, and not later than 90 days after the date of receipt of such information, submit an application for premarket review of the test under section 587B