Data / Federal rules / 2024-06037
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
The Food and Drug Administration published this proposed rule in the Federal Register on March 26, 2024. Comments closed on May 28, 2024.
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What the agency says
The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This proposal follows a court decision vacating a prior ban and amendment to the Federal Food, Drug, and Cosmetic Act clarifying our authority to ban a device for one or more intended uses. This action, if finalized, will mean ESDs for SIB and AB are adulterated and not legally marketed.
Key facts
- Document number
- 2024-06037
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 26, 2024
- Comments due
- May 28, 2024
- Dates
- Either electronic or written comments on the proposed rule must be submitted by May 28, 2024.
- Docket
- Docket No. FDA-2023-N-3902
- Regulation ID (RIN)
- 0910-AI84
- Code of Federal Regulations
- 21 CFR 882; 21 CFR 895
- Topics
- Administrative practice and procedure; Labeling; Medical devices
- Pages
- 16
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on labeling · Rules on medical devices · Published in March 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.