21 U.S.C. § 379k-1

Current through P.L. 118-107 (published on www.congress.gov on 11/21/2024)

Section 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 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.

(2) Guidance contents

In the guidance under paragraph (1), the Secretary may-

(A) provide a timetable for establishment by the Secretary 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.

(b) Devices

(1) In general

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.

(2) Guidance contents

In the guidance under paragraph (1), the Secretary 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 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.

(B) Draft guidance

The Secretary shall, not later than October 1, 2019, issue draft guidance providing for-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);

(ii) a timetable for the establishment by the Secretary of such further standards; and

(iii) criteria for waivers of and exemptions from the requirements of this subsection.

(C) Final 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.

21 U.S.C. § 379k-1

June 25, 1938, ch. 675, §745A, as added Pub. L. 112-144, title XI, §11361136,, 126 Stat. 1123; amended Pub. L. 115-52, title II, §207, Aug. 18, 2017, 131 Stat. 1019.

EDITORIAL NOTES

AMENDMENTS2017-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 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.