TO: AUCD network
FROM: Kim Musheno, Director of Public Policy
As you may know, the Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESD) 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.
AUCD encourages its members to send in separate comments. The more the better. It would be great to receive comments from individuals, family members, physicians, psychologists, neurologists, psychiatrists, behavioral and other experts, not just national organizations.
To submit a comment:
1. Go to the Federal eRulemaking Portal at http://www.regulations.gov
2. Enter the docket number FDA-2016-N-1111
3. Follow the instructions to submit a comment.
4. You may also submit written public comment by mail to:
The Division of Dockets Management (HFA-305), Food and Drug Administration; 5630 Fishers Lane, rm. 1061; Rockville, MD 20852.
Comments are due on May 25, 2016.