This week the FDA has issued a final rule banning Electrical Stimulation Devices (ESD’s) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of injury or illness that cannot be corrected or eliminated through new or updated device labeling.
These devices have been associated with an extensive list of serious psychological harms and physical risks. Many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult for them to communicate their pain or make their own treatment decisions. As these risks couldn’t be corrected or eliminated by a changing in labeling, banning the product was necessary in order to protect the public health. It is not common for the FDA to ban devices, but the FDA takes necessary action.
If you have any questions about how this ban effects your company, feel free to reach out to us via email at firstname.lastname@example.org RE: ESD Ban.