USA - Proposal to Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior

The Food and Drug Administration (FDA or we) 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.

Final date for comments: 25 May 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.