Hello,
Following up on Dan’s message, attached are draft comments from NACDD, AUCD and NDRN. As they are still in draft form, please do not share outside the Council. NACDD is also still working on possible comments from a few coalitions including
the Consortium for Citizens with Disabilities and Alliance to Prevent Restraint, Aversive Interventions and Seclusion.
Please feel free to use as a template to develop your own comments. I encourage everyone to take the time to comment as this is a proposed ban on the use of the device that applies nationwide that we have been waiting for two years to be
released. If you know of other schools or programs to highlight from your state (such as the Centennial School included in these comments), the FDA is looking for additional examples of schools/programs and would suggest including them in your comments.
The official federal register notice, and comments can be filed at
https://federalregister.gov/a/2016-09433. Comments are due by Thursday May 25, 2016.
Regards,
Cindy Smith
As a follow-up to my previous message, the Federal Register notice to be published on April 25th is attached, as is an explanation of the FDA process for banning medical devices.
The Federal Register posting is only a ‘proposed rule’, subject to public comment. It is important that people and organizations submit comments to the FDA during the 30 day comment period. Instructions
for comments are included in the notice.
Time to get to work!
From: Shannon, Dan (ADD)
Sent: Friday, April 22, 2016 10:33 AM
Subject: Breaking News - FDA Proposal to Ban Electrical Stimulation Devices used to treat Self-Injurious or Aggressive Behavior
Importance: High
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
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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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