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 and the FDA Medical Device Bans webpage.

 

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

           

 

 

 

 

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

www.mass.gov/mddc

“Only those who dare to fail greatly can ever achieve greatly.”

Robert F. Kennedy

 

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