Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Risk Classification And The Device-Benefit Question: Cranial Electrotherapy Stimulators

This article was originally published in The Gray Sheet

Executive Summary

Companies are suspicious of FDA motivations in the drawn-out reclassification process for cranial electrotherapy stimulators. But the case also underscores how the agency's efforts to place devices in the appropriate risk category turns not only on the perceived safety of a device, but evidence supporting its benefits and the types of evidence the agency is comfortable accepting.

You may also be interested in...

FDA Issues Split Classification On Cranial Electrotherapy Stimulator Devices

The FDA has moved to finalize a proposed order that would allow cranial electrotherapy stimulator (CES) devices to be marketed via the 510(k) pathway to treat insomnia and anxiety but mandates PMAs for depression indications.

Electroconvulsive Therapy Devices: FDA Proposes 510(k), Special Controls

FDA is proposing to reclassify electroconvulsive therapy devices aimed at treating major depressive disorder to class II with special controls, but require PMAs for other indications. The proposal does not align with a 2011 FDA panel recommendation to keep ECTs for depression in the class III category and require PMAs.

Panel Recommends PMAs For Cranial Electrotherapy Stimulators

FDA’s Neurological Devices panel recommends that pre-amendment cranial electrotherapy stimulator devices should remain in class III, with PMA requirements, due to a lack of efficacy data.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts