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In 2020, it became the third device ever banned by the FDA in the history of the organization. [10]
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The use of the device was condemned as torture by the United Nations special rapporteur on torture. [8] FDA [ edit ] a b c d e "Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior". Federal Register. 2016-04-25 . Retrieved 2020-08-08.
FDORA Passage Brings Significant Changes to FDA's Drug, Device, and Cosmetic Authorities | MoFo Life Sciences". Morrison & Foerster . Retrieved 2023-08-06. A federal court later found that the FDA ban was an "inappropriately promulgated rule". [11] The FDA rule was a ban on using these devices to treat violent or self-injurious behaviors, while not banning the device for "other purposes". [12] A three-judge panel of the U.S. Court of Appeals for the D.C. Circuit found that this was an overstep of its authority, as it cannot regulate the practice of medicine. In response, Congress amended the Federal Food, Drug, and Cosmetic Act to expand FDA's authority and allow them to ban a medical device for a particular use; irrespective, of any other approved use. [2] Specifications and design [ edit ] Observations and Findings of Out-of-State Program Visitation: Judge Rotenberg Educational Center" (PDF). New York State Education Department. June 9, 2006. Archived from the original (PDF) on May 8, 2014 . Retrieved May 8, 2014.
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a b c Grohol, John M.; Founder, Psy D.; read, Editor-in-Chief Last updated: 8 Jul 2018 ~ 3 min (2013-01-30). "Judge Rotenberg Center: One Patient's Story". psychcentral.com. Archived from the original on 2020-08-15 . Retrieved 2020-08-07. {{ cite web}}: |first3= has generic name ( help)THE JUDGE ROTENBERG EDUCATIONAL CENTER, INC., PETITIONER v. UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL" (PDF). The Judge Rotenberg Center filed a lawsuit against the FDA, and in July 2021, the DC Circuit Court overturned the ban, meaning that the school can still use the devices. [31] [32] In response, congress expanded the FDA’s to ban medical devices for a particular use irrespective of approval for other uses. [33] This effectively overturned the ruling reached by the court in 2021. [2] Human rights groups [ edit ]