21 U.S.C. § 360f — Banned devices

Page 359 TITLE 21—FOOD AND DRUGS § 360f and effective use of the device as such device changes pursuant to such plan, notification re- quirements if the device does not function as intended pursuant to such plan, and perform- ance requirements for changes made under the plan. (b) Cleared devices (1) In general Notwithstanding section 360(k) of this title, a premarket notification shall not be required for a change to a device cleared under section 360(k) of this title, if such change is consistent with an established predetermined change con- trol plan granted pursuant to paragraph (2). (2) Predetermined change control plan The Secretary may clear a predetermined change control plan submitted in a notifica- tion submitted under section 360(k) of this title that describes planned changes that may be made to the device (and that would other- wise require a new notification), if— (A) the device remains safe and effective without any such change; and (B) the device would remain substantially equivalent to the predicate. (3) Scope The Secretary may require that a change control plan include labeling required for safe and effective use of the device as such device changes pursuant to such plan, notification re- quirements if the device does not function as intended pursuant to such plan, and perform- ance requirements for changes made under the plan. (c) Predicate devices In making a determination of substantial equivalence pursuant to section 360c(i) of this title, the Secretary shall not compare a device to changed versions of a device implemented in accordance with an established predetermined change control plan as a predicate device. Only the version of the device cleared or approved, prior to changes made under the predetermined change control plan, may be used by a sponsor as a predicate device. (June 25, 1938, ch. 675, § 515C, as added Pub. L. 117–328, div. FF, title III, § 3308(a), Dec. 29, 2022, 136 Stat. 5835.) Editorial Notes PRIOR PROVISIONS A prior section 515C of act June 25, 1938, was renum- bered section 515B and is classified to section 360e–3 of this title. § 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 mar- keted device under section 396 of this title when intended for such use or uses. (b) Special effective date The Secretary may declare a proposed regula- tion under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken re- specting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury as- sociated with the use of the device which is sub- ject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and (2) before the date of the publi- cation of such regulation, the Secretary notifies the manufacturer of such device that such regu- lation is to be made so effective. If the Sec- retary makes a proposed regulation so effective, he shall, as expeditiously as possible, give inter- ested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regula- tion, and either affirm, modify, or revoke such proposed regulation. (June 25, 1938, ch. 675, § 516, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, § 18(d), Nov. 28, 1990, 104 Stat. 4529; Pub. L. 117–328, div. FF, title III, § 3306(a), Dec. 29, 2022, 136 Stat. 5834.) Editorial Notes AMENDMENTS 2022—Subsec. (a). Pub. L. 117–328, § 3306(a)(2), inserted ‘‘or to make such intended use or uses a banned in- tended 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 when intended for such use or uses’’ after ‘‘banned device’’ in concluding provi- sions. Subsec. (a)(1). Pub. L. 117–328, § 3306(a)(1), inserted ‘‘for one or more intended uses’’ before semicolon at end. 1990—Subsec. (a). Pub. L. 101–629 struck out ‘‘and after consultation with the appropriate panel or panels under section 360c of this title’’ after ‘‘data and infor- mation’’ in introductory provisions and struck out at end ‘‘The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection.’’ Statutory Notes and Related Subsidiaries CONSTRUCTION OF 2022 AMENDMENT Pub. L. 117–328, div. FF, title III, § 3306(b), Dec. 29, 2022, 136 Stat. 5834, provided that: ‘‘Nothing in this sec- tion [amending this section] shall be construed to limit 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