; and (iii) by inserting after subparagraph (D) the following new subparagraph: (E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices. ; and (3) in subsection (c), by striking 2017 and inserting 2022 . 207. Electronic format for submissions Section 745A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379k–1(b) ) is amended by adding at the end the following new paragraph: (3) Presubmissions and submissions solely in electronic format (A) In general Beginning on October 1, 2021 (or such later date as may be specified by the Secretary under subparagraph (B)), 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 guidance issued under subparagraph (C). (B) Extension The Secretary may, if the Secretary determines an extension of the date specified in subparagraph (A) is necessary for the development and adoption of the electronic format referred to in such paragraph, extend such date until such later date as the Secretary may specify, but in no event later than April 1, 2023. (C) Guidance The Secretary shall, not later than January 1, 2021, or such later date as may be specified by the Secretary under subparagraph (B), issue guidance providing for— (i) any further standards for the submission by electronic format required under subparagraph (A); (ii) a timetable for the establishment by the Secretary of such further standards