PRIA, Government Policy, Made Personal

Summary

The Secretary must require certain drug, biologic, and device applications to be filed in a digital format the Secretary describes in guidance. For the drug and biologic filings named in the law, that digital-only rule can start no earlier than 24 months after the Secretary issues final guidance that followed public notice and comment. The guidance can also set a timetable for more technical rules and allow waivers or exemptions. The rule does not apply to submissions covered by section 360bbb. For medical device pre-submissions, submissions, their supplements, and some related biologic filings, the Secretary must first require an electronic copy when final guidance is issued. That guidance can set file standards and allow waivers. On a date the Secretary sets in final guidance, those device filings (and appeals) must be submitted only in the specified electronic format. The Secretary had to publish draft guidance by October 1, 2019, and must issue final guidance within 1 year after the public comment period on that draft closes.

Title 21, §379k–1

Food and Drugs, Source: USLM XML via OLRC

(a)(1)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)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)This subsection shall not apply to submissions described in section 360bbb of this title.

(b)(1)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)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)(A)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)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)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.

Notes & Related Subsidiaries

Editorial Notes

Amendments

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

Statutory Notes and Related Subsidiaries

Effective Date

of 2017 AmendmentAmendment 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.

§379k–1 Electronic Format for Submissions