PRIA, Government Policy, Made Personal

Summary

People hurt by certain FDA rules or orders about medical devices have 30 days to ask a U.S. Court of Appeals to review them. You can file in the D.C. Circuit or the federal circuit where you live or have your main business. The court clerk must send a copy of the petition to the Secretary. The Secretary must file the record used to make the rule or order, as required by 28 U.S.C. 2112. The law covers nine kinds of FDA actions, such as device classification changes, performance standards, premarket approval requirements, bans, reclassification decisions, investigational exemptions, and similar orders. The “record” means Federal Register notices, materials sent to the Secretary, advisory panel or committee work, hearings, and any other information the Secretary says is relevant. If the petitioner asks the court to allow new evidence, views, or arguments, the court may allow it if the new material is important and there was a good reason it was not given earlier. The court can order the Secretary to reopen the record and take more written or oral submissions. The Secretary may change or add findings and must file those with the court. The court reviews the action under the Administrative Procedure Act and may grant relief, including temporary relief. A rule that sets or changes a performance standard or bans a device, and an order after review under section 360e(g), cannot be upheld if it is unsupported by substantial evidence on the record taken as a whole. The court’s judgment is final, but the Supreme Court may review it by certiorari or certification under 28 U.S.C. 1254. The remedies here are in addition to any other legal remedies. Each covered rule or order must say why it was issued and show the record items that support it.

Title 21, §360g

Food and Drugs, Source: USLM XML via OLRC

(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,

(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,

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) 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)Finality of judgments

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)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.

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