21 U.S.C. § 360g | Judicial review

(a)

Petition; record

Not later than thirty days after—

(1)

section 360c of this title the promulgation of a regulation under 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)

section 360d of this title the promulgation of a regulation under 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)

section 360e(b) of this title the promulgation of a regulation under paragraph (3) of 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)

section 360f of this title the promulgation of a regulation under (other than a proposed regulation made effective under subsection (b) of such section upon the regulation’s publication) making a device a banned device,

(6)

section 360j(f)(2) of this title the issuance of an order under ,

(7)

section 360j(g)(4) of this title section 360j(g)(5) of this title an order under disapproving an application for an exemption of a device for investigational use or an order under withdrawing such an exemption for a device,

(8)

section 360c(i) of this title an order pursuant to , or

(9)

l a regulation under section 360e(i)(2) or 360j()(5)(B) of this title,

section 2112 of title 28any 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 . 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

section 360e(g) of this titleUpon 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) and an order issued after the review provided by shall not be affirmed if it is found to be unsupported by substantial evidence on the record taken as a whole.

(d)

Finality of judgments

section 1254 of title 28The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in .

(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.

June 25, 1938, ch. 675, § 517 Pub. L. 94–295, § 2May 28, 197690 Stat. 560 Pub. L. 101–629, § 13Nov. 28, 1990104 Stat. 4524 Pub. L. 102–300, § 6(f)June 16, 1992106 Stat. 240 Pub. L. 105–115, title II, § 216(a)(2)Nov. 21, 1997111 Stat. 2349 Pub. L. 112–144, title VI, § 608(a)(2)(C)July 9, 2012126 Stat. 1056(, as added , , ; amended , , ; , , ; , , ; , , .)

Editorial Notes

Amendments

Pub. L. 112–1442012—Subsec. (a)(1). substituted “, an administrative order changing the classification of a device to class I,” for “or changing the classification of a device to class I”.

Pub. L. 105–115, § 216(a)(2)(A)1997—Subsec. (a)(8). , inserted “or” at end.

Pub. L. 105–115, § 216(a)(2)(B)Subsec. (a)(9). , substituted comma for “, or” at end.

Pub. L. 105–115, § 216(a)(2)(C)section 360j(h)(4)(B) of this titleSubsec. (a)(10). , struck out par. (10) which read as follows: “an order under ,”.

Pub. L. 102–3001992—Subsec. (a)(10). substituted “360j(h)(4)(B)” for “360j(c)(4)(B)”.

Pub. L. 101–6291990—Subsec. (a)(8) to (10). added pars. (8) to (10).

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Pub. L. 105–115Nov. 21, 1997section 501 of Pub. L. 105–115 section 321 of this titleAmendment by effective 90 days after , except as otherwise provided, see , set out as a note under .