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# FDA Denies ECT Classification Petition
- URL: https://www.fdaweb.com/fda-denies-ect-classification-petition/
- Published: 2019-01-09T12:00:00.000Z
- Updated: 2026-09-15T00:53:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143124

FDA has denied an 8/25/16 petition asking that the agency either **(1)** promulgate a final regulation banning electroconvulsive therapy (ECT) devices or **(2)** maintain the Class 3 classification of these devices and issue a final order establishing the effective date for PMAs for all ECT devices.

A 2018 final order maintained most ECT devices in Class 3 for some indications and placed them in Class 2 for other indications.

The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-2559-0029&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that after consideration of the literature and public comments received in response to a 2015 proposed order, FDA has concluded that ECT devices do not present a substantial and unreasonable risk of illness or injury for any of the intended uses identified in the 2018 final order. It says the statutory standard for a ban is not met and the agency declines to initiate rulemaking to ban ECT.