People who are psychiatric survivors, including many survivors of shock treatment (ECT) along with our allies and members of MindFreedom International, have joined together and held six teleconferences since December, 2015 when the FDA first released its proposed rule and draft guidance attempting to down-classify the shock device to a Class II device. As discussed in a previous blog, if the FDA’s effort is successful the shock device would be removed from the category of a Class III experimental device, and placed in the same category as eyeglasses or a wheelchair.
Please join us in demanding that the FDA stop the shock device from being down-classified to a Class II device. We have until March 28th, 2016.
A petition has been started:
The final lines:
FDA, by signing this petition, I affirm that my short answer is no.
I oppose FDA down-classifying the shock device from a Class III device to a Class II device for any reason.
I oppose FDA making this rule without public hearings.
I support MindFreedom International’s call for the FDA to hold public hearings prior to making any decisions about the future of shock treatment in the United States.
As we were finalizing the points to include in our template, we learned that the FDA may “choose to redact, or withhold . . . duplicate/near duplicate examples of a mass-mail campaign.” Since it appears that the FDA is censoring comments, please document your comments to the FDA with a screenshot or a copy of the comment and time/date it was submitted. If your comment is not posted to the FDA site because it rejects your comment, please contact Lauren Tenney to discuss (LaurenTenney AT aol dot com or (718) 273-8708).
Along with signing our petition to show the FDA you support MindFreedom International’s opposition to the FDA’s proposed rule, if you would like MindFreedom International to submit comments to the FDA on your behalf, please include your own original comments in the space provided.
If you want to sign our petition, but also want to submit your own comments to the FDA concerning the proposed rule, please be aware that you must include the docket number to which you are responding.
All submissions on the proposed rule must include:
Docket No. 2014-N–1210 for ‘‘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 Devices for Certain Specified Intended Uses”
Click here to submit a comment to the FDA on the proposed rule.
You can also submit a comment on the FDA’s ‘‘guidance document” for industry, clinicians and FDA staff. To do so, please visit http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1318-0001 and click Comment Now.
All submissions on the guidance document must include:
Docket No. FDA-2014-D-1318 for “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians and FDA Staff”
We will be holding another national teleconference on Wednesday, February 24, 2016 at 2pm eastern time, 1 pm central time, 11 am pacific time, 12 pm mountain time.
1-605-475-2090 pin code: 873270 to be part of the call to create a national strategy to respond to the FDA and prevent the shock device from becoming a Class II device.