21 U.S.C. § 379k–1 — Electronic format for submissions

(a) Drugs and biologics. (1) Starting no earlier than 24 months after the FDA issues final guidance (after giving the public notice and a chance to comment), certain drug submissions — those made under section 355(b), (i), or (j) — and certain biologics submissions — those made under 42 U.S.C. § 262(a) or (k) — must be submitted in whatever electronic format the FDA specifies in that guidance. (2) In that guidance, the FDA may: (A) set a timetable for creating further electronic-submission standards; and (B) set the rules for waivers of, and exemptions from, this requirement. (3) Exception. This subsection does not apply to submissions described in section 360bbb. (b) Devices. (1) Once the FDA issues 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, or under 42 U.S.C. § 262, along with any supplements to them, must include an electronic copy. (2) In that guidance, the FDA may: (A) set standards for the required electronic copy; and (B) set the rules for waivers of, and exemptions from, this requirement. (3) Presubmissions and submissions solely in electronic format. (A) Once the FDA specifies a start date in later final guidance under (C), these device presubmissions and submissions — and any appeals of FDA decisions about them — must be submitted only electronically, in the format the FDA specifies. (B) By October 1, 2019, the FDA had to issue draft guidance covering: (i) any further standards needed for electronic submission; (ii) a timetable for creating those standards; and (iii) rules for waivers and exemptions. (C) The FDA had to issue final guidance no later than 1 year after the public comment period on that draft guidance closed.