CCHR-TX Fighting Re-classification of ECT by the FDA

From the FDA:

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

SummaryThe Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) 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, which is a preamendments class III device, into class II (special controls) based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECT devices for other intended uses specified in this proposed order. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements for other intended uses specified in this proposed order. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.

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Action Alert Email from CCHR-Texas:

Psychs Feeling the Effects of Your Comments
Now is the Time to Really Pour on the Coals!

If you're reading this you know...The FDA is trying to re-classify psychiatric electroshock machines into a safer, more benign device classification, moving it from the high-risk Class III to the more safe and effective Class II. And they are trying to do it without bothering to make device makers prove these shock machines are safe and effective.

Comments against this reclassification have been pouring onto the FDA public comment page. And somebody is paying attention:

Last week the American Psychiatric Association issued a new alert calling for comments from psychiatrists in favor of re-classification. Thankfully, someone else is paying attention too:

Last week, Natural News put out three articles about shock machine re-classification, heavily drawing on comments and alerts from CCHR. You can see them here:

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There is no doubt that the re-classification of ECT will fall hard on the pregnant and the elderly.

"Off-label" use of ECT for unapproved uses will no doubt fall on children in states that, unlike Texas, still allow ECT for children.

We have one week left to register public comment against this rule!

If you haven't commented, please do so now. Please, everybody, get friends and family to do so as well. Here's the link:

http://ift.tt/1o6cmX8

Let's get this done!

CCHR-TX Fighting Re-classification of ECT by the FDA