; (iii) establish and maintain records with respect to all requirements in this subparagraph; (iv) maintain records and make reports as required by the Secretary pursuant to regulations issued under subsection (b); and (v) ensure that investigators monitor investigations, maintain records and make reports as required by the Secretary pursuant to regulations issued under subsection (b); and (B) the sponsor may rely on any exception or exemption described in paragraph (4) or as established by the Secretary in regulations issued under subsection (b). (3) Application An investigational use application shall be submitted in such time and manner and contain such information as the Secretary may require in regulation, and shall include an investigational plan for proposed clinical testing and assurances that the sponsor submitting the application will— (A) establish and maintain records relevant to the investigation of such in vitro clinical test; and (B) submit to the Secretary annual reports of data obtained as a result of the investigational use of the in vitro clinical test during the period covered by the exemption that the Secretary reasonably determines will enable the Secretary— (i) to ensure compliance with the conditions for the exemption specified in paragraph (4); (ii) to review the progress of the investigation involved