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

(a)

Drugs and biologics

(1)

In general

section 355 of this title section 262 of title 42Beginning 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 or subsection (a) or (k) of 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

section 360bbb of this titleThis subsection shall not apply to submissions described in .

(b)

Devices

(1)

In general

section 262 of title 42Beginning 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 , 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Draft guidance

October 1, 2019The Secretary shall, not later than , issue draft guidance providing for—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.

June 25, 1938, ch. 675, § 745A Pub. L. 112–144, title XI, § 1136July 9, 2012126 Stat. 1123 Pub. L. 115–52, title II, § 207Aug. 18, 2017131 Stat. 1019(, as added , , ; amended , , .)

Editorial Notes

Amendments

Pub. L. 115–522017—Subsec. (b)(3). added par. (3).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

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