Sec. 811. Bans of devices for one or more intended uses
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/bill/117/hr/7667/eh/section-811·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 516(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360f(a) ) is amended— in paragraph (1), by inserting for one or more intended use before the semicolon at the end; and in the matter following paragraph (2), by inserting for any such intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under section 1006 when intended for such use or uses after banned device . Section 516 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360f ) is further amended by adding at the end the following:
Electrical stimulation devices that apply a noxious electrical stimulus to a person’s skin intended to reduce or cease self-injurious behavior or aggressive behavior are deemed to be banned devices, as described in subsection (a). Devices banned under this section are banned devices unless or until the Secretary promulgates a regulation to make such devices or use of such devices no longer banned based on a finding that such devices or use of such devices does not present substantial deception or an unreasonable and substantial risk of illness or injury, or that such risk can be corrected or eliminated by labeling. .
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Sec. 811
Bans of devices for one or more intended uses
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