{"id":3381,"date":"2013-06-10T20:19:19","date_gmt":"2013-06-10T20:19:19","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3381"},"modified":"2013-06-10T20:19:19","modified_gmt":"2013-06-10T20:19:19","slug":"presentation-on-navigating-fdas-home-use-medical-devices-draft-guidance","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/06\/10\/presentation-on-navigating-fdas-home-use-medical-devices-draft-guidance\/","title":{"rendered":"Presentation on Navigating FDA&#8217;s Home Use Medical Devices Draft Guidance"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Leo Eisner will be presenting on the topic \u201cNavigating FDA\u2019s Draft Guidance on Home Use Medical Devices\u201d at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM \u2013 Noon (Pacific), 2:00PM \u2013 3:00PM (Eastern). \u00a0You don\u2019t have to leave your office to join in on the presentation and as a\u00a0<strong><em>special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 discount.<br \/>\n<\/em><\/strong><\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"><strong><!--more-->What\u2019s it about:<\/strong>\u00a0\u00a0The FDA published its draft guidance on Design Considerations for Devices Intended for Home Use in December of 2012, as part of an initiative started back in April 2010 \u201cto support the safe use of medical devices in the home.\u201d The guidance document is a significant step forward helping manufacturers understand the design criteria, user environments to consider, environmental considerations, and labeling issues. It also looks at other standards and FDA guidance manufacturers should consider, as well as post-market considerations, and other vital aspects of designing and developing devices that are intended to make the devices safer and easier to use.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Join us for this timely and informative audio conference presentation as our speaker takes attendees on a guided tour of the draft guidance. The presentation reviews the key points of the document as it relates to the IEC 60601-1-11 standard (Home Use Medical Electrical Equipment), human factors and usability (user environment), environmental considerations, labeling, and design controls (including risk management).<br \/>\n<\/span><br \/>\n<span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"> <strong>This audio conference will cover:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Variations in the definition of home-use device under FDA and IEC 60601-1-11<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">How the draft guidance relates to FDA\u2019s Medical Device Home Use Initiative<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Environmental considerations discussed in the draft guidance<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">User environments to be considered<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Key elements to keep in mind when designing home-use devices<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Labeling considerations<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">Post-market considerations<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">And more<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">To\u00a0<strong><em>find out more about the presentation &amp; discount ($50.00 off regular price)\u00a0<a href=\"http:\/\/www.eisnersafety.com\/events\/\">click here<\/a><\/em><\/strong>\u00a0for the details and also some other\u00a0<strong><em><a href=\"http:\/\/www.eisnersafety.com\/Events#Past_Presentations\">past presentations<\/a><\/em><\/strong>\u00a0that Eisner Safety Consultants have presented for FX Conferences previously.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Leo Eisner will be presenting on the topic \u201cNavigating FDA\u2019s Draft Guidance on Home Use Medical Devices\u201d at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM \u2013 Noon (Pacific), 2:00PM \u2013 3:00PM (Eastern). \u00a0You don\u2019t have to<\/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":[45,61,15,16,225,403,54,919,920,921,922,41,47,843,923,404,924,55,925,926,163,844,845,846,927,74,654,1042,928,173,27,9,10,1043,93,88,89,784,91,17,13,218,842,414,857,858,929,930,931,932,933,934,935,936,937,938,939,416,53,94,95,899,37,912,1044,22,330,174,175,149,861,940,620,5,621,289,1045,1046],"class_list":["post-3381","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-510k","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-60601-1-11","tag-a1","tag-aami","tag-aami-es-60601-1-2005a1-2012","tag-aami-es-60601-105a112","tag-aami-es-60601-12005-a12012","tag-aami-es-60601-12005a12012","tag-aami-es60601-1","tag-aami-es60601-1c1","tag-aami-ha60601-1-11","tag-aamiiec-tir-6234812","tag-amendment-1","tag-amendment-1-to-iec-60601-12005","tag-ansi","tag-ansi-aamiiec","tag-ansiaami-es-60601-12005a12012","tag-ansiaami-es60601-1","tag-ansiaami-ha60601-1-11","tag-ansiaami-ha60601-1-112011","tag-ansiaami-ha60601-1-112011-iec-60601-1-112010","tag-ansiaamiiec-tir-623482012","tag-cdrh","tag-consolidated-edition","tag-environmental-considerations","tag-es-60601-12005-a12012","tag-esc","tag-escnews","tag-fda","tag-fda-guidance","tag-fdas-home-use-initiative","tag-home-healthcare-environments","tag-home-use","tag-home-use-environment","tag-home-use-initiative","tag-home-use-med-dvcs","tag-human-factors","tag-iec","tag-iec-60601-1","tag-iec-60601-1-a1","tag-iec-60601-1-3rd-ed","tag-iec-60601-1-11-1st-ed","tag-iec-60601-1-112010","tag-iec-tr-62348","tag-iec-tr-62348-2nd-ed","tag-iec-tr-62348-2nd-edition","tag-iec-tr-6234812","tag-iec-tr-623482012","tag-iec-tr62348","tag-iec-tr62348-2012","tag-iec-tr62348-2nd-ed","tag-iec-tr62348-2nd-edition","tag-iec-tr6234812","tag-iec-tr623482012","tag-iec60601","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-11","tag-international-electrotechnical-commission","tag-labeling","tag-labels","tag-marking","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-medical-electrical-equipment","tag-moderate-changes","tag-moderate-impact","tag-risk-management","tag-significant-impact","tag-usability","tag-usability-analysis","tag-use-environments"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3381","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=3381"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3381\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3381"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3381"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3381"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}