U.S. Code » Title 21 » Chapter CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— DRUGS AND DEVICES › Part Part A— Drugs and Devices

21 U.S.C. § 360f

Banned devices

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(a) General ruleWhenever 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 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, and (2) before the date of the publication of such regulation, the Secretary notifies the manufacturer of such device that such regulation is to be made so effective. If the Secretary makes a proposed regulation so effective, he shall, as expeditiously as possible, give interested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regulation, 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 NotesAmendments

2022—Subsec. (a). Pub. L. 117–328, § 3306(a)(2), inserted “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 when intended for such use or uses” after “banned device” in concluding provisions.

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 information” 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 SubsidiariesConstruction of 2022 Amendment

Pub. L. 117–328, div. FF, title III, § 3306(b), Dec. 29, 2022, 136 Stat. 5834, provided that: “Nothing in this section [amending this section] shall be construed to limit 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 pursuant to such section 516, as amended by this section.”

Notes of Decisions
Cited in 9 cases (2 in the last 5 years), 1978–2025 · leading case: Holistic Candlers & Consumers Ass'n v. Food & Drug Admin., 664 F.3d 940 (D.C. Cir. 2012).
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Holistic Candlers & Consumers Ass'n v. Food & Drug Admin., 664 F.3d 940 (D.C. Cir. 2012). “19-20 (citing 21 U.S.C. § 360f). Moreover, unlike EPA, which “gave no indication that [its position was] subject to further agency consideration or possible modification,” Ciba-Geigy, 801 F.”
Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011). “21 U.S.C. § 360f(a)(2). If the FDA concludes that a device “presents an unreasonable risk of substantial harm to the public,” it may require the manufacturer to notify all affected individuals, or require repair or replacement of the device.”
The Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 2021). · cites it 2× “Analysis The answer to the controlling issue is determined by the application of two statutes: 21 U.S.C. § 360f, which authorizes the FDA to ban medical devices, and 21 U.”
Ginochio v. Surgikos, Inc., 864 F. Supp. 948 (N.D. Cal. 1994). “§ 360d (performance standards); 21 U.S.C. § 360f (power to ban); 21 U.S.C.”
Ethicon, Inc. v. Food & Drug Admin., 762 F. Supp. 382 (D.D.C. 1991). “Part 820); the banning of devices (21 U.S.C. § 360f, 21 C.F.R. Part 895); and device labelling requirements ( 21 U.”
Anderson v. Dep't of Health & Human Servs., 907 F.2d 936 (10th Cir. 1990). “21 U.S.C. § 360f(a). . Even if the district court had made clear findings of which documents contained trade secrets and which contained confidential commercial or financial information, we would still need to remand for supplementation of the record.”
Bryant v. Thoratec Corp., 343 F. Supp. 3d 594 (S.D. Miss. 2018). “Plaintiffs' FAC alleges that Defendants failed "to adequately label and/or warn of the inherent risk of the device as contemplated by 21 U.S.C. § 360f." FAC ¶ 33(p). Plaintiffs' proposed amendment adds: "Defendants did not change the labeling, 5 nor adequately warn the…”
Becton, Dickinson & Co. v. Food & Drug Admin., 448 F. Supp. 776 (N.D.N.Y. 1978). “Also included within the Amendments are provisions relating to banned devices, see Food, Drug and Cosmetic Act § 516, 21 U.S.C. § 360f, and, more relevant to the case sub judice, restricted devices, see Food, Drug and Cosmetic Act § 520(e), 21 U.”
Judge Rotenberg Educ. Ctr., Inc. v. U.S. Food & Drug Admin. (D.D.C. 2025). · cites it 2× “at 394 , constrained the FDA’s authority under 21 U.S.C. § 360f, “which authorizes the FDA to ban medical devices,” id.”
— 21 U.S.C. § 360f(a) — 2 cases
The Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 2021). “Analysis The answer to the controlling issue is determined by the application of two statutes: 21 U.S.C. § 360f, which authorizes the FDA to ban medical devices, and 21 U.”
Anderson v. Dep't of Health & Human Servs., 907 F.2d 936 (10th Cir. 1990). “21 U.S.C. § 360f(a). . Even if the district court had made clear findings of which documents contained trade secrets and which contained confidential commercial or financial information, we would still need to remand for supplementation of the record.”
— 21 U.S.C. § 360f(a)(2) — 1 case
Gelber v. Stryker Corp., 788 F. Supp. 2d 145 (S.D.N.Y. 2011). “21 U.S.C. § 360f(a)(2). If the FDA concludes that a device “presents an unreasonable risk of substantial harm to the public,” it may require the manufacturer to notify all affected individuals, or require repair or replacement of the device.”
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