Medical Device Safety and Recalls: Comment Period extended to July 25, 2016 --FDA seeks public comment on Proposed Rule; Proposal To Ban Electrical Stimulation Devices (ESDs) Used To Treat Self-Injurious or Aggressive Behavior

The Food and Drug Administration (FDA) is extending the comment period to July 25, 2016 for the document titled “Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior.” The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. Electrical Stimulation Devices (ESDs) send electrical shocks through electrodes attached to an individual’s skin to attempt to condition them against engaging in self-injurious or aggressive behaviors. A number of significant psychological and physical risks are associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, and tissue damage. Banning the product is necessary to protect the public because these risks cannot be corrected through new or updated labeling. More information about medical device bans can be found on the FDA’s Medical Device Bans webpage. Thank you, Food and Drug Administration Center for Devices and Radiological Health