> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guidance on Electroconvulsive Therapy Devices
- URL: https://www.fdaweb.com/guidance-on-electroconvulsive-therapy-devices/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134313

*Federal Register* Notice: FDA is making available a draft guidance entitled *Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff*. Its purpose is to make recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT Devices into Class II (special controls) for severe major depressive episode associated with major depressive disorder or bipolar disorder 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. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM478942?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32591.pdf?ref=fdaweb.com)