2015 US Code
Title 21 - Food and Drugs (Sections 1 - 2252)
Chapter 9 - Federal Food, Drug, and Cosmetic Act (Sections 301 - 399f)
Subchapter V - Drugs and Devices (Sections 351 - 360fff-7)
Part A - Drugs and Devices (Sections 351 - 360n-1)
Sec. 360g-1 - Agency documentation and review of significant decisions regarding devices
| Publication Title | United States Code, 2012 Edition, Supplement 3, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 360g-1 - Agency documentation and review of significant decisions regarding devices |
| Contains | section 360g-1 |
| Date | 2015 |
| Laws In Effect As Of Date | January 3, 2016 |
| Positive Law | No |
| Disposition | standard |
| Source Credit | June 25, 1938, ch. 675, §517A, as added Pub. L. 112-144, title VI, §603, July 9, 2012, 126 Stat. 1051. |
| Statutes at Large Reference | 126 Stat. 1051 |
| Public and Private Law | Public Law 112-144 |
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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 documentationUpon 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 decisionAny 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 requestA 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 generalExcept 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) ExceptionSubparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration.
(June 25, 1938, ch. 675, §517A, as added Pub. L. 112–144, title VI, §603, July 9, 2012, 126 Stat. 1051.)
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