---
kind: "section"
citation: "21 U.S.C. § 379k–1"
title: "21"
title_heading: "Food and Drugs"
number: "379k–1"
heading: "Electronic format for submissions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379k-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part D — Information and Education"
---

# §379k–1. Electronic format for submissions

- (a) **Drugs and biologics—**
  - (1) **In general—** 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](/usc/21/355.md) or subsection (a) or (k) of [section 262 of title 42](/usc/42/262.md) shall be submitted in such electronic format as specified by the [Secretary](/usc/21/321.md?p=d) in such guidance.
  - (2) **Guidance contents—** In the guidance under [paragraph (1)](#a-1), the [Secretary](/usc/21/321.md?p=d) may—
    - (A) provide a timetable for establishment by the [Secretary](/usc/21/321.md?p=d) of further standards for electronic submission as required by such paragraph; and
    - (B) set forth criteria for waivers of and exemptions from the requirements of this subsection.
  - (3) **Exception—** This subsection shall not apply to submissions described in [section 360bbb of this title](/usc/21/360bbb.md).
- (b) **Devices—**
  - (1) **In general—** Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for [devices](/usc/21/321.md?p=h-1) under section [360(k)](/usc/21/360.md?p=k), [360c(f)(2)(A)](/usc/21/360c.md?p=f-2-A), [360e(c)](/usc/21/360e.md?p=c), [360e(d)](/usc/21/360e.md?p=d), [360e(f)](/usc/21/360e.md?p=f), [360j(g)](/usc/21/360j.md?p=g), [360j(m)](/usc/21/360j.md?p=m), or [360bbb–3](/usc/21/360bbb–3.md) of this title or [section 262 of title 42](/usc/42/262.md), and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.
  - (2) **Guidance contents—** In the guidance under [paragraph (1)](#b-1), the [Secretary](/usc/21/321.md?p=d) may—
    - (A) provide standards for the electronic copy required under such paragraph; and
    - (B) set forth criteria for waivers of and exemptions from the requirements of this subsection.
  - (3) **Presubmissions and submissions solely in electronic format—**
    - (A) **In general—** Beginning on such date as the [Secretary](/usc/21/321.md?p=d) specifies in final guidance issued under [subparagraph (C)](#b-3-C), presubmissions and submissions for [devices](/usc/21/321.md?p=h-1) described in [paragraph (1)](#b-1) (and any appeals of action taken by the [Secretary](/usc/21/321.md?p=d) with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the [Secretary](/usc/21/321.md?p=d) in such guidance.
    - (B) **Draft guidance—** The [Secretary](/usc/21/321.md?p=d) shall, not later than October 1, 2019, issue draft guidance providing for—
      - (i) any further standards for the submission by electronic format required under [subparagraph (A)](#b-3-A);
      - (ii) a timetable for the establishment by the [Secretary](/usc/21/321.md?p=d) of such further standards; and
      - (iii) criteria for waivers of and exemptions from the requirements of this subsection.
    - (C) **Final guidance—** The [Secretary](/usc/21/321.md?p=d) shall, not later than 1 year after the close of the public comment period on the draft guidance issued under [subparagraph (B)](#b-3-B), issue final guidance.

## Source credit

(June 25, 1938, ch. 675, § 745A, as added Pub. L. 112–144, title XI, § 1136, July 9, 2012, 126 Stat. 1123; amended Pub. L. 115–52, title II, § 207, Aug. 18, 2017, 131 Stat. 1019.)

## Notes

### Editorial Notes

### Amendments

2017—Subsec. (b)(3). Pub. L. 115–52 added par. (3).

### Statutory Notes and Related Subsidiaries

### Effective Date of 2017 Amendment

Amendment by title II of Pub. L. 115–52, effective Oct. 1, 2017, except that fees under subpart 3 of part C of this subchapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.