Has FDA reclassified Electroconvulsive Therapy (ECT)?



Has anyone heard of the final decision over the proposed reclassification of Electroconvulsive Therapy by FDA?

The commenting period for the proposed rule stopped in March this year; I couldn't find any updates on this though. Wonder if ECT machines will be class ii device soon.

Ajit Basrur

Re: ECT Reclassification

Welcome to the Cove :bigwave:

The ECT falls under 21 CFR 882.5849, and I see it is listed as Class II


882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

(b) Classification. Class II (performance standards).


Inactive Registered Visitor
There's no required timeframe (that I know of) for FDA to finalize a rule after the comment period, so it may take a while.
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