FDA Comment Period Closes on Proposed Ban of Electrical Stimulation Devices for Behavioral Treatment

The Food and Drug Administration (FDA) has closed the comment period for its proposed rule to ban electrical stimulation devices used for treating self-injurious or aggressive behavior. This proposal marks the FDA’s second attempt to prohibit the controversial practice, following a legislative change that restored the agency’s authority to enforce such bans.

The FDA’s initial ban, finalized in 2020, was overturned by the U.S. Court of Appeals for the District of Columbia in 2021. The court ruled that while the FDA could ban medical devices, it did not have the authority to ban specific uses of those devices. However, Congress addressed this gap by passing the Food and Drug Omnibus Reform Act of 2022, granting the FDA clear authority to ban specific intended uses of medical devices.

This renewed effort by the FDA cites significant psychological and physical risks associated with the use of electrical stimulation devices for behavior modification. The agency asserts that these risks cannot be adequately mitigated through device labeling alone. The proposed rule does not impact aversive conditioning devices intended for other purposes outside the scope of this rule. Currently, approximately 50 patients are undergoing treatment plans involving these devices.

ANCOR led a campaign urging community providers and advocates to submit comments supporting the ban. The campaign successfully generated 469 comments, emphasizing the harmful impacts and advocating for safer and evidence-based treatment alternatives.

The agency will now review the feedback before making a final decision on the proposed rule. The outcome will determine the future use of a practice deemed hazardous by many advocates and health professionals.