Documentation of rationale for significant decisions
In general
section 360(k) of this titlesection 360c(f) of this titlesection 360e of this titlesection 360j(g) of this titleThe 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 , a petition for classification under , an application under , or an application for an exemption under , including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.
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.
Application of least burdensome requirements
section 360c(i)(1)(D) of this titlesection 360c(a)(3)(D) of this titlesection 360e(c)(5) of this titleThe substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with , , and , as applicable.
Review of significant decisions
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.
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.
Timeframe
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.
Exception
Subparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration.
June 25, 1938, ch. 675, § 517APub. L. 112–144, title VI, § 603126 Stat. 1051Pub. L. 114–255, div. A, title III130 Stat. 1124Pub. L. 117–328, div. FF, title III, § 3308(b)(3)136 Stat. 5836(, as added , , ; amended , §§ 3051(b), 3058(c), , , 1129; , , .)
Editorial Notes
Amendments
Pub. L. 117–328section 360(k) of this titlesection 360e of this titlesection 360e–3 of this titlesection 360j(g) of this title2022—Subsec. (a)(1). amended par. (1) generally. Prior to amendment, text read as follows: “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 , an application under , a request for designation under , or an application for an exemption under , including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.”
Pub. L. 114–255, § 3051(b)section 360e–3 of this titlesection 360e of this title2016—Subsec. (a)(1). , inserted “a request for designation under ,” after “application under ,”.
Pub. L. 114–255, § 3058(c)Subsec. (a)(3). , added par. (3).