FDA Advisors Recommend Ban on Electronic Stimulus Devices for People with Disabilities

AUCD's Kim Musheno provided testimony on behalf of network members

April 28, 2014


pdf File AUCD testimony by Kim Musheno (204KB) [download]

pdf File FDA event summary (291KB) [download]

pdf File APRAIS testimony (323KB) [download]

pdf File TASH testimony (320KB) [download]

Kim testifying
AUCD's Kim Musheno testifies before the FDA advisory panel
On April 25, 2014, AUCD participated in an open public hearing of an Federal Drug and Food Administration (FDA) advisory committee reviewing evidence of the risks and benefits associated with using Electronic Stimulus Devices (electric shocks) for behavior modification. The FDA put together the committee and heard testimony from the public to help them determine whether the agency should ban these devices. By law, a medical device for human use may be banned if it presents "substantial deception or an unreasonable and substantial risk of illness or injury."  Daniel Armstrong, Ph.D., of the Miami Mailman Center (UCEDD/LEND) participated on the advisory panel.

Kim Musheno, AUCD's Director of Public Policy, delivered AUCD's statement urging the panel to recommend banning the devices and read testimony prepared by AUCD Policy Committee Member Mark Smith of the Nebraska UCEDD/LEND.  AUCD was one of 17 organizations registered to testify, all in favor of banning the device.  Several representatives of the Judge Rotenberg Center, the only known center to still use such devices, testified in favor of approving such devices.  A majority of the advisory committee appeared to agree that the risks outweigh the benefits. The next step will be for the FDA to issue a proposed rule, followed by an opportunity for public input before a final rule is published.

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