21 U.S.C. § 379k-1 Electronic Format For Submissions

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 379k-1

(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.