This is the body of an email I got from Vince Boehm, written by Vince, regarding the FDA hearings for Electroshock devices. (used for electro-convulsive “therapy” or ECT) Wanted to pass on the information for anyone who might be able to testify.
Background: Electroshock devices have been on the market since 1937, but have never undergone the approval process for safety and efficacy required by the FDA for devices of this type. These devices were “grandfathered” into the system when the U.S. Food and Drug Administration assumed jurisdiction in this area in 1976.
There will be an FDA hearing on the proposed reclassification of devices indicated for use in electroconvulsive therapy. The Food and Drug Administration has classified the devices used to administer ECT as Class III medical devices. Class III is the highest-risk class of medical devices. A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I (tongue depressors, etc) or Class II (treadmills, ultrasound, etc) devices.
The industry-proposed reclassification of these devices to the lower Class II has been on the FDA docket for many years. Two years ago, the agency sent letters to the manufacturers demanding that these devices to undergo clinical trials for safety and efficacy. The industry has not responded.
A Class III device needs premarket approval. Class II devices do not!
Proof of safety or efficacy will never happen if these machines get reclassified to Class II.
This will be “Put Up or Shut Up Time” for the shock industry if these devices remain in Class III.
I plan to go to this hearing. I am certain that many members of this list will testify in the Public Comment portion of this hearing as well. Please let me know if you will attend and testify. If you cannot go, you can submit a written statement.
Public safety and public responsibility demands that these devices get a full review by its regulatory agency.
Attached to the email were these two FDA announcements:
January 27-28, 2011, Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Food and Drug Administration
[Docket No. FDA-2010-N-0585]
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues.
Date and Time: The meeting will be held on January 27 and 28, 2011, from 8 a.m. to 6 p.m. (see the whole thing here)
Public Conduct During FDA Advisory Committee Meetings
The FDA would like to ensure that advisory committee meetings proceed in an orderly fashion, are conducted in a safe and secure environment, that the right of free speech is protected, and that the ability of FDA Advisory Committees and Panels to accomplish their objectives is not disrupted. Therefore, the following procedures will be followed: (see here)
For additional posts on ECT on this blog see here.