C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 882—NEUROLOGICAL DEVICES › Subpart F—Neurological Therapeutic Devices

21 C.F.R. § 882.5235

Aversive conditioning device

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(a) Identification. An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics.

(b) Classification. Class II (special controls), except for electrical stimulation devices for self-injurious or aggressive behavior. Electrical stimulation devices for self-injurious or aggressive behavior are banned. See § 895.105 of this chapter.

[44 FR 51730, Sept. 4, 1979, as amended at 85 FR 13354, Mar. 6, 2020]
Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2021–2021 · leading case: The Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 2021).
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The Judge Rotenberg Educ. Ctr., Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 2021). “21 C.F.R. § 882.5235 . That classification includes all medical devices that the FDA determines are reasonably safe and effective when subject to special controls like postmarket surveillance and patient registries.”
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