{"id":4309,"date":"2015-07-29T18:39:42","date_gmt":"2015-07-29T18:39:42","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4309"},"modified":"2015-07-29T18:39:42","modified_gmt":"2015-07-29T18:39:42","slug":"back-by-popular-demand-wearable-medical-devices-fdas-current-thinking","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/07\/29\/back-by-popular-demand-wearable-medical-devices-fdas-current-thinking\/","title":{"rendered":"Back by Popular Demand &#8211; Wearable Medical Devices \u2013 FDA&#8217;s Current Thinking"},"content":{"rendered":"<p><strong><\/strong><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2015\/07\/Dexcom-SmartWatch-App-2.gif\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-4317\" style=\"border: 0px; margin: 2px;\" title=\"Dexcom SmartWatch App 2\" src=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2015\/07\/Dexcom-SmartWatch-App-2.gif\" alt=\"\" width=\"154\" height=\"198\" \/><\/a>As this presentation was so well attended in July FX Conferences has decided to rerun this presentation twice in August so those that missed it can obtain this critical information for the Wearable Medical Device industry. \u00a0Leo Eisner will be speaking on Medical Device Wearables &amp; FDA&#8217;s Current Thinking with respect to a slew of new guidance documents that could apply to your devices. \u00a0This presentation is being offered 2 times in August (Tuesday August 11, 9:30AM Eastern and Wednesday August 12, 2:00PM Eastern). \u00a0No travel required to go to this presentation just dial in, download the material &amp; you&#8217;re set to learn from Leo Eisner, an industry expert. \u00a0Receive a $50.00 (US$) discount as a special thank you for visiting us at Eisner Safety Consultants (See below).<\/p>\n<p><strong>What&#8217;s it about:<\/strong>\u00a0The presentation guides you through many significant issues concerning the design &amp; development of wearable medical devices. Leo will provides an in-depth look at the FDA guidance documents that may apply to your wearables, including the Home Use Environment,\u00a0Mobile Medical Applications, \u00a0Accessories, and\u00a0General Wellness \u00a0guidances among additional broader based ones.<\/p>\n<p>Join us for this audio conference presentation and bring your group up \u00a0to speed as Leo guides you through the wide variety of FDA Guidances that may apply to your Wearable Medical Device.\u00a0<strong>This audio conference will cover:<\/strong><\/p>\n<ul>\n<li>Does the FDA consider your \u00a0wearable a medical device?<\/li>\n<li>FDA\u2019s Final Guidances on Mobile Medical Applications &amp; Home Use Environment<\/li>\n<li>The differences between the IEC &amp; AAMI Home Use Environment Medical Electrical Equipment and Systems Standard (60601-1-11) and it&#8217;s impact on the FDA Home Use Guidance<\/li>\n<li>Draft General Wellness &amp; Accessories Guidances<\/li>\n<li>Additional Regulations that may impact your Wearable device beyond the FDA<\/li>\n<\/ul>\n<p><em><strong><a href=\"http:\/\/www.eisnersafety.com\/events\/\" target=\"_blank\" rel=\"noopener noreferrer\">Click here<\/a><\/strong><\/em>\u00a0for the details on the<em><strong>\u00a0presentation &amp; discount ($50.00 off regular price)<\/strong><\/em>\u00a0and also some other\u00a0<strong><em><a href=\"http:\/\/www.eisnersafety.com\/Events#Past_Presentations\" target=\"_blank\" rel=\"noopener noreferrer\">past presentations<\/a><\/em><\/strong>\u00a0from FX Conferences that we have presented.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As this presentation was so well attended in July FX Conferences has decided to rerun this presentation twice in August so those that missed it can obtain this critical information for the Wearable Medical Device industry. \u00a0Leo Eisner will be<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[225,843,1237,1238,9,10,1239,1240,1241,1242,885,1243,1244,1232,88,89,1245,309,858,149,1246,893,1213,1247,1248,1214],"class_list":["post-4309","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-1-11","tag-aami-ha60601-1-11","tag-accessories","tag-accessories-guidance","tag-fda","tag-fda-guidance","tag-fda-guidance-document","tag-fda-guidance-documents","tag-fda-guidances","tag-fda-mobile-medical-applications-guidance","tag-fda-recognized-consensus-standards","tag-general-wellness","tag-general-wellness-guidance","tag-ha60601-1-11","tag-home-use","tag-home-use-environment","tag-home-use-environment-guidance","tag-iec-60601-1-11","tag-iec-60601-1-112010","tag-medical-devices","tag-mobile-medical-applications","tag-recognized-consensus-standards","tag-wearable","tag-wearable-medical-device","tag-wearable-medical-devices","tag-wearables"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4309","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=4309"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4309\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4309"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4309"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}