1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/Comment on External Pacemaker Reclassification - Public Citizenrich600338<blockquote class="wp-embedded-content" data-secret="sQ3w7pBUXp"><a href="https://www.citizen.org/article/comment-on-external-pacemaker-reclassification/">Comment on External Pacemaker Reclassification</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/comment-on-external-pacemaker-reclassification/embed/#?secret=sQ3w7pBUXp" width="600" height="338" title="“Comment on External Pacemaker Reclassification” — Public Citizen" data-secret="sQ3w7pBUXp" 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>
Public Citizen strongly urges the Food and Drug Administration (FDA) to withdraw its proposed rule to reclassify the external pacemaker pulse generator preamendment Class III device arbitrarily to Class II (special controls) and to publish a new notice immediately that proposes a final regulation requiring the device to remain in Class III, and requiring premarket approval applications for new external pacemaker pulse generators.https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628