From: FDA Office of Health and Constituent Affairs [mailto:xxxxxx@fda.hhs.gov]
Sent: Friday, April 22, 2016 9:03 AM
To: FDA Office of Health and Constituent Affairs
Subject: Proposal to Ban Electrical Stimulation Devices used to treat Self-Injurious or Aggressive Behavior

Good morning,

Today FDA announced that it is proposing to ban electrical stimulation devices used to treat aggressive or self-injurious behavior.  FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.  FDA is proposing to include in this ban both new devices and devices already in distribution and use.

For more information, please view the Federal Register display notice<https://www.federalregister.gov/articles/2016/04/25/2016-09433/banned-devices-electrical-stimulation-devices-used-to-treat-self-injurious-or-aggressive-behavior> and the FDA Medical Device Bans webpage<http://www.fda.gov/MedicalDevices/Safety/MedicalDeviceBans/default.htm>.

Sincerely,

Shannon Thor, PharmD, MS

Lieutenant, US Public Health Service

Health Programs Coordinator
Office of Health & Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration
[U.S. Food and Drug Administration]<http://www.fda.gov/>    [Follow FDA on Facebook] <https://www.facebook.com/FDA>   [Follow FDA on Twitter] <https://twitter.com/US_FDA>   [View FDA videos on YouTube] <http://www.youtube.com/user/USFoodandDrugAdmin>   [View FDA photostream on Flickr] <http://www.flickr.com/photos/fdaphotos/>   [Subscribe to FDA RSS feeds] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

Daniel M. Shannon, Executive Director
MA Developmental Disabilities Council
100 Hancock St., Suite 201
Quincy, MA 02171
Phone - 617-770-7676 X108
Fax - 617-770-1987
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