; and (ii) determine whether the criteria listed in paragraph (1) apply to the in vitro clinical test and communicate such determination to the developer as described in subparagraph (D). (D) Communication and results of determination The Secretary shall notify the developer, in writing, of the Secretary's determination under subparagraph (C), as follows: (i) If the Secretary determines that none of the criteria listed in paragraph (1) apply to the in vitro clinical test, such test shall be exempt from relevant requirements of this subchapter, as set forth in subsection (b), subject to the criteria under subsection (a). (ii) If the Secretary determines that one or more of the criteria listed in paragraph (1) apply to the test but such a determination may be resolved within a reasonable time, and the test has not been previously subject to this subsection on the basis of the same or substantially similar scientific concerns identified in the written request issued under paragraph (d)(2)(A)— (I) the Secretary shall notify the developer of such a determination and allow the developer to seek a teleconference to discuss the finding; (II) the developer shall submit information demonstrating resolution of the determination within 15 days of receiving such notification; and (III) the Secretary shall make a determination within 30 days of the receipt of such submission of information as to whether the criteria under paragraph (1) continue to apply to the test and, if through such determination the Secretary determines that— (aa) none of the criteria listed in paragraph (1) apply to the test, such test shall be exempt from relevant requirements of the subchapter as set forth in subsection (b), subject to applicable limitations