21 USC § 360g–1 - Agency documentation and review of significant decisions regarding devices

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This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

(a) Documentation of rationale for significant decisions

(1) In general

The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 360 (k) of this title, an application under section 360e of this title, or an application for an exemption under section 360j (g) of this title, including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.

(2) Provision of documentation

Upon request, the Secretary shall furnish such substantive summary to the person who is seeking to submit, or who has submitted, such report or application.

(b) Review of significant decisions

(1) Request for supervisory review of significant decision

Any person may request a supervisory review of the significant decision described in subsection (a)(1). Such review may be conducted at the next supervisory level or higher above the individual who made the significant decision.

(2) Submission of request

A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after such decision and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review.

(3) Timeframe

(A) In general

Except as provided in subparagraph (B), the Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the person requesting a review under this subsection not later than 45 days after the request is made under paragraph (1), or, in the case of a person who requests an in-person meeting or teleconference, 30 days after such meeting or teleconference.

(B) Exception

Subparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration.

This preliminary release may be subject to further revision before it is released again as a final version. As with other online versions of the Code, the U.S. Code Classification Tables should be consulted for the latest laws affecting the Code. Those using the USCPrelim should verify the text against the printed slip laws available from GPO (Government Printing Office), the laws as shown on THOMAS (a legislative service of the Library of Congress), and the final version of the Code when it becomes available.

Current through Pub. L. 112-173. (See Public Laws for the current Congress.)

Source

(June 25, 1938, ch. 675, § 517A, as added Pub. L. 112–144, title VI, § 603,July 9, 2012, 126 Stat. 1051.)

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Wednesday, December 26, 2012

An empty table indicates that we see no relevant changes listed in the classification tables. If you suspect that our system may be missing something, please double-check with the Office of the Law Revision Counsel.

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Abbreviations used in the Description of Change column:

An empty field implies a standard amendment.
"new" means a new section or new note, or all new text of an existing section or note.
"nt" means note.
"nt [tbl]" means note [table].
"prec" means preceding.
"fr" means a transfer from another section.
"to" means a transfer to another section.
"omitted" means the section is omitted.
"repealed" means the section is repealed.
"nt ed change" and "ed change" - See the Editorial Classification Change Table [pdf].

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General Reference

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Refer to the Thomas site for changes that have not yet made it into the classification tables.

21 USC	Description of Change	Session Year	Public Law	Statutes at Large
§ 360g-1	new	2012	112-144 [Sec.] 603 "517A"	126 Stat. 1051

21 USC § 360g–1 - Agency documentation and review of significant decisions regarding devices

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