---
kind: "section"
citation: "21 U.S.C. § 360f"
title: "21"
title_heading: "Food and Drugs"
number: "360f"
heading: "Banned devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360f"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360f. Banned devices

- (a) **General rule—** Whenever the [Secretary](/usc/21/321.md?p=d) finds, on the basis of all available data and information, that—
  - (1) a [device](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=d) determined could be corrected or eliminated by [labeling](/usc/21/321.md?p=m) or change in [labeling](/usc/21/321.md?p=m) and with respect to which the [Secretary](/usc/21/321.md?p=d) provided written notice to the [manufacturer](/usc/21/360hh.md?p=3) specifying the deception or risk of illness or injury, the [labeling](/usc/21/321.md?p=m) or change in [labeling](/usc/21/321.md?p=m) to correct the deception or eliminate or reduce such risk, and the period within which such [labeling](/usc/21/321.md?p=m) or change in [labeling](/usc/21/321.md?p=m) was to be done, such [labeling](/usc/21/321.md?p=m) or change in [labeling](/usc/21/321.md?p=m) was not done within such period;

  he may initiate a proceeding to promulgate a regulation to make such [device](/usc/21/321.md?p=h-1) a banned [device](/usc/21/321.md?p=h-1) or to make such intended use or uses a banned intended use or uses. A [device](/usc/21/321.md?p=h-1) that is banned for one or more intended uses is not a legally marketed [device](/usc/21/321.md?p=h-1) under [section 396 of this title](/usc/21/396.md) when intended for such use or uses.

- (b) **Special effective date—** The [Secretary](/usc/21/321.md?p=d) may declare a proposed regulation under [subsection (a)](#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](/usc/21/321.md?p=h-1) 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](/usc/21/321.md?p=d) notifies the [manufacturer](/usc/21/360hh.md?p=3) of such [device](/usc/21/321.md?p=h-1) that such regulation is to be made so effective. If the [Secretary](/usc/21/321.md?p=d) makes a proposed regulation so effective, he shall, as expeditiously as possible, give interested [persons](/usc/21/321.md?p=e) prompt notice of his action under this subsection, provide reasonable opportunity for an [informal hearing](/usc/21/321.md?p=x) on the proposed regulation, and either affirm, modify, or revoke such proposed regulation.

## Source credit

(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.)

## Notes

### Editorial Notes

### Amendments

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 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 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.”