Sec. 810. Bans of devices for one or more intended uses
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/bill/117/hr/7667/ih/section-810·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). Such devices are banned unless or until the Secretary promulgates a regulation to make such devices no longer banned based on a finding that such devices do not present 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. 810
Bans of devices for one or more intended uses
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