All presubmissions and submissions to the Food and Drug Administration with respect to an in vitro clinical test shall include an electronic copy of such presubmission or submission, and, with respect to the information required under sections 587B and 587D, shall utilize the system described in section 587T. (b) Electronic format Beginning on such date as the Secretary specifies in final guidance issued under subsection (c), presubmissions and submissions for in vitro clinical tests (and any appeals of action taken by the Secretary with respect to such presubmissions and submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance. (c) Guidance The Secretary shall issue guidance implementing this section. In such guidance, the Secretary may— (1) provide standards for the electronic copy required under subsection (a) or the submission in electronic format required under subsection (b)