; (2) provides such documentation relating to the change to the Secretary upon request or inspection; and (3) does not modify the in vitro clinical test such that it no longer meets the criteria under subsection (a). (d) Request for information (1) Criteria The criteria described in this paragraph are any of the following: (A) There is a lack of valid scientific evidence to support that the in vitro clinical test is analytically valid or clinically valid. (B) Such in vitro clinical test is being offered by its developer with any false or misleading analytical or clinical claims. (C) It is probable that such in vitro clinical test will cause serious adverse health consequences. (2) Process (A) Written request for information The Secretary may issue a written request to a developer identifying specific scientific concerns, based on credible information, with an in vitro clinical test, which indicate that one or more of the criteria described in paragraph (1) apply to such in vitro clinical test. Such written request shall include specific information requests pertaining to such criteria. (B) Deadline for submitting information Not later than 45 days after receiving a request for information under subparagraph (A)— (i) the developer of an in vitro clinical test— (I) may seek a teleconference prior to the submission of information under subclause (II) to discuss the Secretary's request; and (II) shall submit the information requested pursuant to subparagraph (A), and may include in such submission a request for a teleconference; and (ii) the Secretary shall— (I) schedule a teleconference requested under clause (i)(I); and (II) hold a teleconference if requested within 10 days of the Secretary's receipt of the information submitted under clause (i)(II). (C) Review deadline Upon receiving a submission under subparagraph (B), the Secretary shall— (i) review the submitted information within 45 calendar days of such receipt, which may include communication with the developer