2024 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter V - Drugs and Devices
Part A - Drugs and Devices
Sec. 360f - Banned devices

Whenever the Secretary finds, on the basis of all available data and information, that—

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.

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.)

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."

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."