§360g — Title 21 Food and Drugs | U.S. Code

Summary

You can ask a federal court to review certain FDA actions, but you must file your petition within 30 days. The rule covers nine kinds of agency actions, for example: changing a device’s classification, setting or changing performance rules, denying reclassification or exemptions, ordering premarket approval, or banning a device. If you want to add new evidence or arguments in court, you can ask permission. The court may allow it if the new material is important and you had a good reason for not giving it earlier. The court can order the agency to take more oral or written submissions. The agency can change its findings and must file those changes and any recommendation with the court. The court will review the action under the usual federal review rules and can give relief, including temporary relief. Certain kinds of rules and some post-review orders cannot be upheld unless supported by substantial evidence in the whole record. The court’s judgment is final unless the Supreme Court takes the case. These rights are in addition to any other legal remedies. Every such regulation or order must include a clear statement of why it was issued and the record basis for that decision.

Title 21, §360g

Food and Drugs — Source: USLM XML via OLRC

(a)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,

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

(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,

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

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

(b)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)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) 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.

(d)The 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 section 1254 of title 28.

(e)The remedies provided for in this section shall be in addition to and not in lieu of any other remedies provided by law.

(f)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.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2012—Subsec. (a)(1). Pub. L. 112–144 substituted “, 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. 102–300 substituted “360j(h)(4)(B)” for “360j(c)(4)(B)”. 1990—Subsec. (a)(8) to (10). Pub. L. 101–629 added pars. (8) to (10).

Statutory Notes and Related Subsidiaries

Effective Date

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

§360g Judicial Review