1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/rich600338<blockquote class="wp-embedded-content" data-secret="mXezyHk1x9"><a href="https://www.citizen.org/article/letter-regarding-appropriate-classification-of-electroconvulsive-therapy-ect-devices/">Letter Regarding Appropriate Classification of Electroconvulsive Therapy (ECT) Devices</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/letter-regarding-appropriate-classification-of-electroconvulsive-therapy-ect-devices/embed/#?secret=mXezyHk1x9" width="600" height="338" title="“Letter Regarding Appropriate Classification of Electroconvulsive Therapy (ECT) Devices” — Public Citizen" data-secret="mXezyHk1x9" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript"> /* <![CDATA[ */ /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); /* ]]> */ </script> In order to protect the health and welfare of patients, electroconvulsive (ECT) devices should remain classified as class III, and FDA should require that rigorous, ethically justifiable clinical trials be conducted to evaluate the safety and effectiveness of ECT devices, and that data from such trials be submitted to FDA for review and evaluation under a Premarket Approval Application (PMA).https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628