PRIA, Government Policy, Made Personal

Summary

The Secretary can start a process to ban a medical device or ban a particular way it is used when, based on all available information, the device either seriously misleads people or poses an unreasonable and substantial risk of illness or injury for one or more uses. If the problem could be fixed by changing the device’s labeling, the Secretary must have told the manufacturer in writing what to change and given a time to do it. If the maker did not make the required labeling change in that time, the Secretary can move forward to create a regulation that bans the device or that intended use. A device banned for certain uses is not legally marketed when used for those purposes under section 396. If the Secretary finds the device’s deception or risk is an unreasonable, direct, and substantial danger to health, the Secretary can make a proposed ban take effect as soon as it is published in the Federal Register, but only after telling the manufacturer beforehand. If a proposed ban is made effective this way, the Secretary must quickly notify interested people, offer a chance for an informal hearing, and then confirm, change, or cancel the proposed ban.

Title 21, §360f

Food and Drugs, Source: USLM XML via OLRC

(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 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.

Notes & Related Subsidiaries

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.”

§360f Banned Devices