" [Docket No. FDA-2014-N-1210] Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses."
"As the (INSERT YOUR INTEREST IN ISSUE, ex. “mother of someone with mental illness”) I SUPPORT the reclassification of electronconvulsive therapy devices to a Class II device to treat severe Major Depressive Episode associated with Major Depressive Disorder and Bipolar Disorder in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. The terms "treatment resistant" and the phrase "require rapid response" do provide sufficient clarity to the population for which ECT benefits outweigh risks. I appreciate that in making this reclassification, the FDA is relying on the voice of science, rather than anti-psychiatry. The FDA previously held hearings on the issue in 2011. Reclassification is important. "
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