21 U.S. Code § 360g - Judicial review
(a)
Petition; record
Not later than thirty days after—
(1)
the promulgation of a regulation under section
360c of this title classifying a device in class I, an administrative order changing the classification of a device to class I, or an order under subsection (f)(2) of such section reclassifying a device or denying a petition for reclassification of a device,
(2)
the promulgation of a regulation under section
360d of this title establishing, amending, or revoking a performance standard for a device,
(3)
the issuance of an order under section
360d
(b)(2) or
360e
(b)(2)(B) of this title denying a request for reclassification of a device,
(4)
the promulgation of a regulation under paragraph (3) of section
360e
(b) of this title requiring a device to have an approval of a premarket application, a regulation under paragraph (4) of that section amending or revoking a regulation under paragraph (3), or an order pursuant to section
360e
(g)(1) or
360e
(g)(2)(C) of this title,
(5)
the promulgation of a regulation under section
360f of this title (other than a proposed regulation made effective under subsection (b) of such section upon the regulation’s publication) making a device a banned device,
(7)
an order under section
360j
(g)(4) of this title disapproving an application for an exemption of a device for investigational use or an order under section
360j
(g)(5) of this title withdrawing such an exemption for a device,
any person adversely affected by such regulation or order may file a petition with the United States Court of Appeals for the District of Columbia or for the circuit wherein such person resides or has his principal place of business for judicial review of such regulation or order. A copy of the petition shall be transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary shall file in the court the record of the proceedings on which the Secretary based his regulation or order as provided in section
2112 of title
28. For purposes of this section, the term “record” means all notices and other matter published in the Federal Register with respect to the regulation or order reviewed, all information submitted to the Secretary with respect to such regulation or order, proceedings of any panel or advisory committee with respect to such regulation or order, any hearing held with respect to such regulation or order, and any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.
(b)
Additional data, views, and arguments
If the petitioner applies to the court for leave to adduce additional data, views, or arguments respecting the regulation or order being reviewed and shows to the satisfaction of the court that such additional data, views, or arguments are material and that there were reasonable grounds for the petitioner’s failure to adduce such data, views, or arguments in the proceedings before the Secretary, the court may order the Secretary to provide additional opportunity for the oral presentation of data, views, or arguments and for written submissions. The Secretary may modify his findings, or make new findings by reason of the additional data, views, or arguments so taken and shall file with the court such modified or new findings, and his recommendation, if any, for the modification or setting aside of the regulation or order being reviewed, with the return of such additional data, views, or arguments.
(c)
Standard for review
Upon the filing of the petition under subsection (a) of this section for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter
7 of title
5 and to grant appropriate relief, including interim relief, as provided in such chapter. A regulation described in paragraph (2) or (5) of subsection (a) of this section and an order issued after the review provided by section
360e
(g) of this title shall not be affirmed if it is found to be unsupported by substantial evidence on the record taken as a whole.
(e)
Remedies
The remedies provided for in this section shall be in addition to and not in lieu of any other remedies provided by law.
(f)
Statement of reasons
To facilitate judicial review under this section or under any other provision of law of a regulation or order issued under section
360c,
360d,
360e,
360f,
360h,
360i,
360j, or
360k of this title each such regulation or order shall contain a statement of the reasons for its issuance and the basis, in the record of the proceedings held in connection with its issuance, for its issuance.
Source
(June 25, 1938, ch. 675, § 517, as added Pub. L. 94–295, § 2,May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, § 13,Nov. 28, 1990, 104 Stat. 4524; Pub. L. 102–300, § 6(f),June 16, 1992, 106 Stat. 240; Pub. L. 105–115, title II, § 216(a)(2),Nov. 21, 1997, 111 Stat. 2349; Pub. L. 112–144, title VI, § 608(a)(2)(C),July 9, 2012, 126 Stat. 1056.)
Amendments
2012—Subsec. (a)(1). Pub. L. 112–144substituted “, an administrative order changing the classification of a device to class I,” for “or changing the classification of a device to class I”.
1997—Subsec. (a)(8). Pub. L. 105–115, § 216(a)(2)(A), inserted “or” at end.
Subsec. (a)(9). Pub. L. 105–115, § 216(a)(2)(B), substituted comma for “, or” at end.
Subsec. (a)(10). Pub. L. 105–115, § 216(a)(2)(C), struck out par. (10) which read as follows: “an order under section
360j
(h)(4)(B) of this title,”.
1992—Subsec. (a)(10). Pub. L. 102–300substituted “360j(h)(4)(B)” for “360j(c)(4)(B)”.
1990—Subsec. (a)(8) to (10). Pub. L. 101–629added pars. (8) to (10).
Effective Date of 1997 Amendment
Amendment by Pub. L. 105–115effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as a note under section
321 of this title.
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