Sec. 207. Electronic format for submissions

162 words·~1 min read·/bill/115/hr/2430/eh/section-207

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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: 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 The Secretary shall, not later than October 1, 2019, issue draft guidance providing for— any further standards for the submission by electronic format required under subparagraph (A); a timetable for the establishment by the Secretary of such further standards; and criteria for waivers of and exemptions from the requirements of this subsection. The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance. .

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21 USC 379k–1(b)

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Sec. 207

Electronic format for submissions

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