Has FDA reclassified Electroconvulsive Therapy (ECT)?

[ZZquid]

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.5890

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).

 

[Marcelo]

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.

 

[ZZquid]

Thanks much, Marcelo and Ajit!