FDA Proposal to Ban Electrical Stimulation Devices - Related Documents - Comments Needed Shannon, Dan (ADD) 22 Apr 2016 11:36 EDT
Show/hide attachmentsAs 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! 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<http://www.mass.gov/mddc> "Only those who dare to fail greatly can ever achieve greatly." Robert F. Kennedy Follow us on... [Description: https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcQNS8bGyz04zU9pA4kQAJgXH5kZmSFkK34zjK-j1XqxLHYgbht_MA]<https://twitter.com/MA_DDC>[Description: https://encrypted-tbn1.gstatic.com/images?q=tbn:ANd9GcTavAMJIMRzsfEyopA8i4wlK_hKHx39UcStADAsBQdY088T71Cq]<https://www.facebook.com/MassDDCouncil> [Description: https://encrypted-tbn3.gstatic.com/images?q=tbn:ANd9GcS_KBSva52lJmi_3s1GCrTH32-2ulRBtmFe35g_o3sxeac0etrCvg] <http://www.mass.gov/anf/employment-equal-access-disability/oversight-agencies/mddc/news-and-updates.xml> [Description: https://encrypted-tbn1.gstatic.com/images?q=tbn:ANd9GcQYHd3V6b9ymOt0JA_dsdDBhbmRrT1VZLouxHHxklwZg5woNIUEtA] <http://www.youtube.com/user/MassDDCouncil> www.mass.gov/mddc<http://www.mass.gov/mddc> 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<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 www.mass.gov/mddc<http://www.mass.gov/mddc> "Only those who dare to fail greatly can ever achieve greatly." Robert F. Kennedy Follow us on... [Description: https://encrypted-tbn0.gstatic.com/images?q=tbn:ANd9GcQNS8bGyz04zU9pA4kQAJgXH5kZmSFkK34zjK-j1XqxLHYgbht_MA]<https://twitter.com/MA_DDC>[Description: https://encrypted-tbn1.gstatic.com/images?q=tbn:ANd9GcTavAMJIMRzsfEyopA8i4wlK_hKHx39UcStADAsBQdY088T71Cq]<https://www.facebook.com/MassDDCouncil> [Description: https://encrypted-tbn3.gstatic.com/images?q=tbn:ANd9GcS_KBSva52lJmi_3s1GCrTH32-2ulRBtmFe35g_o3sxeac0etrCvg] <http://www.mass.gov/anf/employment-equal-access-disability/oversight-agencies/mddc/news-and-updates.xml> [Description: https://encrypted-tbn1.gstatic.com/images?q=tbn:ANd9GcQYHd3V6b9ymOt0JA_dsdDBhbmRrT1VZLouxHHxklwZg5woNIUEtA] <http://www.youtube.com/user/MassDDCouncil> www.mass.gov/mddc<http://www.mass.gov/mddc>