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

Summary

You can ask a court to review certain FDA rules or orders, but you must file the request within thirty days after the rule or order is issued. The law covers nine kinds of FDA actions about medical devices, such as device classification changes, performance standards, premarket approval requirements, banned devices, denial or withdrawal of investigational exemptions, and related orders. If you missed giving some evidence or arguments to the agency, you can ask the court to allow more. The court may let the agency take more written or oral submissions if the new material is important and you had a good reason for not giving it earlier. The court reviews the rule or order under the usual federal review process and can give relief, including temporary relief. Rules that set performance standards or ban devices, and orders issued after the agency’s internal review, must be supported by substantial evidence on the whole record or the court will not uphold them. The court’s decision is final unless the Supreme Court agrees to hear the case. The remedies here do not replace other legal remedies. Each rule or order must state the reasons for it and the record basis for those reasons.

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