Evidence shows that the use of these devices is incredibly dangerous, posing risks to both psychological and physical health. The FDA has finally determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. The proposed ban will include both new devices and devices already in distribution and use.
This ban is long overdue. Join TASH and other members of the Alliance to Prevent Restraint, Aversive Interventions and Seclusion (APRAIS) in supporting this ban. Comments are due on Monday, July 25, 2016. You can submit them online at regulations.gov by clicking on the “comment now” button, or you can mail your comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.
If you are submitting comments that you would like to be held confidential, you must submit them by mail.