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."
On December 29, 2015, tune in at 9:00 AM Eastern to hear a reading of the published document.
Read along with me here: https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592.pdf
To see the Federal Register: https://www.federalregister.gov/articles/2015/12/29/2015-32592/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-intended-for-use-in#h-7
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.
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.