Browse Arkansas Code titles and sections

21 U.S.C. § 360g — Judicial review

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360g — Judicial review

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360g

Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.

Original supplied file — preserved unchanged

Download original Markdown file

File SHA-256: 6793d588c55f49881975682ee5eff476f646c282a6e49f7eeb8c00c5f1a9dab7. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.

Authority boundary: historical or unconfirmed source not current law verified.

Open the recorded source website ↗

Record provenance

Stable record: federal_law:legal_authorities:record_usc_eceaf65b89c9a5776e117dc1
Source file: Laws/federal/codes/united-states-code/title-21/section-360g-judicial-review--6d42242538.md
Pages: Not recorded – Not recorded
Passage SHA-256: 8e0add41c707966fbc03bee7649f40cd9ad6075f3378f017427eb5070b6efe73

Source location: Title 21, Chapter 9, § 360g; chapter-009-federal-food-drug-and-cosmetic-act.md

Stored source content

**(a) Petition; record** Not later than thirty days after— (1) the promulgation of a regulation under [section 360c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/b&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360f&num=0&edition=prelim) (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/f/2&num=0&edition=prelim), (7) an order under [section 360j(g)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g/4&num=0&edition=prelim) disapproving an application for an exemption of a device for investigational use or an order under [section 360j(g)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g/5&num=0&edition=prelim) withdrawing such an exemption for a device, (8) an order pursuant to [section 360c(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/i&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section2112&num=0&edition=prelim). 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/g&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section1254&num=0&edition=prelim). **(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.

Cross-references

Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360f — Banned devices

**(a) General rule** Whenever the Secretary finds, on the basis of all available data and information, that— (1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury for one or more intended uses; and (2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period; he may initiate a proceeding to promulgate a regulation to make such device a banned device or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under [section 396 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section396&num=0&edition=prelim) when intended for such use or uses. **(b) Special effective date** The Secretary may declare a proposed regulation under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals,

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360f

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360d — Performance standards

**(a) Reasonable assurance of safe and effective performance; periodic evaluation** (1) The special controls required by [section 360c(a)(1)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/a/1/B&num=0&edition=prelim) shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under subsection (b) if the device has been reclassified as a class II device under an administrative order under [section 360c(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/e&num=0&edition=prelim) (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation) provides that the reclassification is not to take effect until the effective date of such a standard for the device. (2) A performance standard established under subsection (b) for a device— (A) shall include provisions to provide reasonable assurance of its safe and effective performance; (B) shall, where necessary to provide reasonable assurance of its safe and effective performance, include— (i) provisions respecting the construction, components, ingredients, and properties of the device and its compatibility with power systems and connections to such systems, (ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the device or, if it is determined that no other more practicable means are available to the Secretary to assure the conformity of the device to the standard, provisions for

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360d

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

28 U.S.C. § 1254 — Courts of appeals; certiorari; certified questions

Cases in the courts of appeals may be reviewed by the Supreme Court by the following methods: (1) By writ of certiorari granted upon the petition of any party to any civil or criminal case, before or after rendition of judgment or decree; (2) By certification at any time by a court of appeals of any question of law in any civil or criminal case as to which instructions are desired, and upon such certification the Supreme Court may give binding instructions or require the entire record to be sent up for decision of the entire matter in controversy.

Source: Supplied U.S. Code snapshot — release unconfirmed · 28 U.S.C. § 1254

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 321 — Definitions; generally

For the purposes of this chapter— **(a)** (1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. **(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. **(c)** The term “Department” means Department of Health and Human Services. **(d)** The term “Secretary” means the Secretary of Health and Human Services. **(e)** The term “person” includes individual, partnership, corporation, and association. **(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. **(g)** (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

28 U.S.C. § 2112 — Record on review and enforcement of agency orders

**(a)** The rules prescribed under the authority of [section 2072 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title28-section2072&num=0&edition=prelim) may provide for the time and manner of filing and the contents of the record in all proceedings instituted in the courts of appeals to enjoin, set aside, suspend, modify, or otherwise review or enforce orders of administrative agencies, boards, commissions, and officers. Such rules may authorize the agency, board, commission, or officer to file in the court a certified list of the materials comprising the record and retain and hold for the court all such materials and transmit the same or any part thereof to the court, when and as required by it, at any time prior to the final determination of the proceeding, and such filing of such certified list of the materials comprising the record and such subsequent transmittal of any such materials when and as required shall be deemed full compliance with any provision of law requiring the filing of the record in the court. The record in such proceedings shall be certified and filed in or held for and transmitted to the court of appeals by the agency, board, commission, or officer concerned within the time and in the manner prescribed by such rules. If proceedings are instituted in two or more courts of appeals with respect to the same order, the following shall apply: (1) If within ten days after issuance of the order the agency, board, commission, or officer concerned receives, from the persons instituting the proceedings, the petition for review with respect to proceedings in at least two courts of appeals, the agency, board, commission, or officer shall proceed in accordance with paragraph (3) of this subsection. If within ten days after the is

Source: Supplied U.S. Code snapshot — release unconfirmed · 28 U.S.C. § 2112

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360c — Classification of devices intended for human use

**(a) Classes of devices** (1) There are established the following classes of devices intended for human use: (A) *Class I, General Controls.—* (i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device. (ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it— (I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and (II) does not present a potential unreasonable risk of illness or injury, is to be regulated by the controls referred to in clause (i). (B) *Class II, Special Controls.—* — A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim)), recommendations, and other appropri

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360c

Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

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- em

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360g

Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.