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Talk with Tenney: Special: Tell the FDA No to Reclassifying the Shock Device

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Lauren Tenney

Lauren Tenney

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Call in (267) 521-0167 On December 30, 2015, from 9-11 PM Eastern, there will be a Special Episode of Talk with Tenney: Tell the FDA NO to Reclassifying the Shock Device. 

Please join in to hear from people who have survived electroshock, the stories of people who have not survived, and concerned allies, in a move to try to combat the FDA's move to downgrade the shock device from a Class III experimental Device to a Class II device for those who are deemed "treatment resistant" or who "require a rapid response". 

 

At 8:45 AM on December 29, 2015, the FDA will be publishing: "Neurological Devices: 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; Reclassification; etc./"

From the draft document:  

"FDA is inviting comments on whether the term "treatment resistant" and the phrase "require rapid response" provide sufficient clarity to the population for which ECT benefits outweigh risks."

 FDA -- I am sure we will have plenty to say on what is meant by "Treatment Resistant" and "Require Rapid Response". 

We will have 90 days to respond to the open docket -- 90 days to try to stop this from happening.  

 

(to hear a reading of the document, recorded on December 29, 2015 @ 9 AM please visit \

http://www.blogtalkradio.com/talkwithtenney/2015/12/29/talk-with-tenney-special-reading-of-shock-fda-reclassification-document

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