The following information must be included in your response to the FDA Proposal to reclassify the electroconvulsive therapy into Class II.
[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.
Go – FDA – Go
After all Benefits Outweigh Risks
Re-Classify the Electroshock Device
– in favor of U.S.A. Economy-
Forget about the risk of death, disablement, autobiographical destruction to recipients of electroconvulsive therapy – right? Anyway FDA why should you concern yourself with the source of economical growth?
Go for it FDA
so what if the electroshock device carries the following adverse events as documented in the Federal Register:
Adverse reaction to anesthetic agents/neuromuscular blocking…
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