Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall be submitted in such electronic format as specified by the Secretary in such guidance.
This subsection shall not apply to submissions described in section 360bbb of this title.
Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or section 262 of title 42, and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.
Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.
The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.