Editorial Notes

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.”