21 U.S.C. § 360g — Judicial review

Page 360 TITLE 21—FOOD AND DRUGS § 360g the authority of the Secretary [of Health and Human Services] to amend, in accordance with section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360f), as amended by this section, and chapter 5 of title 5, United States Code, regulations promulgated pursu- ant to such section 516, as amended by this section.’’ § 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 reclassi- fying a device or denying a petition for reclas- sification of a device, (2) the promulgation of a regulation under section 360d of this title establishing, amend- ing, 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 re- quiring a device to have an approval of a pre- market application, a regulation under para- graph (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 publica- tion) 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 ex- emption 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 Co- lumbia or for the circuit wherein such person re- sides 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 offi- cer designated by him for that purpose. The Sec- retary 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 informa- tion 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 re- spect to such regulation or order, as being rel- evant 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 re- viewed and shows to the satisfaction of the court that such additional data, views, or argu- ments are material and that there were reason- able grounds for the petitioner’s failure to ad- duce such data, views, or arguments in the pro- ceedings before the Secretary, the court may order the Secretary to provide additional oppor- tunity 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 rec- ommendation, if any, for the modification or setting aside of the regulation or order being re- viewed, with the return of such additional data, views, or arguments. (c) Standard for review Upon the filing of the petition under sub- section (a) of this section for judicial review of a regulation or order, the court shall have juris- diction to review the regulation or order in ac- cordance 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 Su- preme Court of the United States upon certio- rari 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 regula- tion 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, 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.) Editorial Notes AMENDMENTS 2012—Subsec. (a)(1). Pub. L. 112–144 substituted ‘‘, an administrative order changing the classification of a Page 361 TITLE 21—FOOD AND DRUGS § 360g–2 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), in- serted ‘‘or’’ at end. Subsec. (a)(9). Pub. L. 105–115, § 216(a)(2)(B), sub- stituted 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 sec- tion 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 AMENDMENT Amendment 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–1. Agency documentation and review of significant decisions regarding devices (a) Documentation of rationale for significant de- cisions (1) In general The Secretary shall provide a substantive summary of the scientific and regulatory ra- tionale for any significant decision of the Cen- ter for Devices and Radiological Health re- garding submission or review of a report under section 360(k) of this title, a petition for clas- sification under section 360c(f) of this title, an application under section 360e of this title, or an application for an exemption under section 360j(g) of this title, including documentation of significant controversies or differences of opinion and the resolution of such controver- sies or differences of opinion. (2) Provision of documentation Upon request, the Secretary shall furnish such substantive summary to the person who is seeking to submit, or who has submitted, such report or application. (3) Application of least burdensome require- ments The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome require- ments were considered and applied consistent with section 360c(i)(1)(D) of this title, section 360c(a)(3)(D) of this title, and section 360e(c)(5) of this title, as applicable. (b) Review of significant decisions (1) Request for supervisory review of signifi- cant decision Any person may request a supervisory re- view of the significant decision described in subsection (a)(1). Such review may be con- ducted at the next supervisory level or higher above the individual who made the significant decision. (2) Submission of request A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after such decision and shall indicate in the request whether such person seeks an in-person meet- ing or a teleconference review. (3) Timeframe (A) In general Except as provided in subparagraph (B), the Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the person requesting a review under this subsection not later than 45 days after the request is made under paragraph (1), or, in the case of a person who requests an in-per- son meeting or teleconference, 30 days after such meeting or teleconference. (B) Exception Subparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration. (June 25, 1938, ch. 675, § 517A, as added Pub. L. 112–144, title VI, § 603, July 9, 2012, 126 Stat. 1051; amended Pub. L. 114–255, div. A, title III, §§ 3051(b), 3058(c), Dec. 13, 2016, 130 Stat. 1124, 1129; Pub. L. 117–328, div. FF, title III, § 3308(b)(3), Dec. 29, 2022, 136 Stat. 5836.) Editorial Notes AMENDMENTS 2022—Subsec. (a)(1). Pub. L. 117–328 amended par. (1) generally. Prior to amendment, text read as follows: ‘‘The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any signifi- cant decision of the Center for Devices and Radio- logical Health regarding submission or review of a re- port under section 360(k) of this title, an application under section 360e of this title, a request for designa- tion under section 360e–3 of this title, or an application for an exemption under section 360j(g) of this title, in- cluding documentation of significant controversies or differences of opinion and the resolution of such con- troversies or differences of opinion.’’ 2016—Subsec. (a)(1). Pub. L. 114–255, § 3051(b), inserted ‘‘a request for designation under section 360e–3 of this title,’’ after ‘‘application under section 360e of this title,’’. Subsec. (a)(3). Pub. L. 114–255, § 3058(c), added par. (3). § 360g–2. Third party data transparency (a) In general To the extent the Secretary relies on any data, analysis, or other information or findings provided by entities that has been funded in whole or in part by, or otherwise performed under contract with, the Food and Drug Admin- istration, in regulatory decision-making with respect to devices, the Secretary shall— (1) request access to the datasets, inputs, clinical or other assumptions, methods, ana- lytical code, results, and other components underlying or comprising the analysis, conclu- sions, or other findings upon which the Sec- retary seeks to rely; and (2) in the event that information described in paragraph (1) is used to support regulatory decision-making, and as otherwise appro- priate, to the extent practicable, provide the manufacturer or manufacturers subject to such decision a summary of such information, subject to protection of confidential commer- cial information or trade secret information or personally identifiable information.