{"id":13352,"date":"2019-10-30T12:23:07","date_gmt":"2019-10-30T11:23:07","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=13352"},"modified":"2023-01-24T15:02:04","modified_gmt":"2023-01-24T14:02:04","slug":"fda-updates-list-of-recognized-standards-for-medical-device-premarket-reviews","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2019\/10\/30\/fda-updates-list-of-recognized-standards-for-medical-device-premarket-reviews\/","title":{"rendered":"FDA updates list of recognized standards for medical device premarket reviews"},"content":{"rendered":"\n<p>Modifications to the initial list of <strong>recognized standards<\/strong> were announced\u00a0 on October 24, 2019, when the latest list of recognized standards \u201c<em><a href=\"https:\/\/www.federalregister.gov\/documents\/2019\/10\/24\/2019-23198\/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Recognition List Number: 052<\/a><\/em>\u201d was published in the Federal Register.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/10\/3_FDA-list-recognized-standards-medical-device-premarket-reviews-1024x536.png\" alt=\"\" class=\"wp-image-13347\"\/><figcaption><em>FDA updates list of recognized standards for medical device premarket reviewsi<\/em><\/figcaption><\/figure>\n\n\n\n<p>The <strong>latest list<\/strong> includes additions,\nwithdrawals, corrections and revisions of certain consensus standards\nrecognized by the FDA. Several areas have been impacted, such as:\nanesthesiology, biocompatibility, in vitro diagnostics (IVD), materials,\nnanotechnology, ophthalmic and orthopedic. <\/p>\n\n\n\n<p>On September 14, 2018, FDA announced their guidance entitled \u201c<em><a rel=\"noreferrer noopener\" aria-label=\"Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices (si apre in una nuova scheda)\" href=\"http:\/\/www.thema-med.com\/en\/linea-guida-sullutilizzo-appropriato-degli-standard-volontari-nelle-richieste-pre-market-dispositivi-medici\/\" target=\"_blank\">Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices<\/a><\/em>\u201d describing how FDA has implemented its standards recognition program. <\/p>\n\n\n\n<p>Among the <strong>most important new-entries<\/strong> in\nthe list of recognized standards, we cite:<\/p>\n\n\n\n<p><strong>Dental\/Ear, Nose and Throat (ENT)<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>ISO\n14801 (Third edition 2016-11-01) <em>Dentistry\u2014Implants\u2014Dynamic loading test for\nendosseous dental implants;<\/em>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/li><\/ul>\n\n\n\n<p><strong>Orthopedics<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>ISO\n15142-1 (First edition 2003-08-01) <em>Implants for surgery\u2014Metal intramedullary\nnailing systems\u2014Part 1-3<\/em>; <\/li><li>ISO\n14242-4 (First edition 2018-05) <em>Implants for surgery\u2014Wear of total hip-joint\nprostheses\u2014Part 4: Testing hip prostheses under variations in component\npositioning which results in direct edge loading<\/em>;<\/li><li>ISO\n7206-10 (Second edition 2018-08) <em>Implants for surgery\u2014Partial and total\nhip-joint prostheses\u2014Part 10: Determination of resistance to static load of\nmodular femoral heads<\/em>;<\/li><\/ul>\n\n\n\n<p><strong>Software\/Informatics<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>ANSI\/AAMI\/UL\n2800-1:2019 (American National Standard) <em>Standard for Safety for Medical\nDevice Interoperability.<\/em><\/li><\/ul>\n\n\n\n<p><em>Published on October 30, 2019.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Modifications to the initial list of recognized standards were announced\u00a0 on October 24, 2019, when the latest list of recognized standards  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2,23,1513],"tags":[],"class_list":["post-13352","post","type-post","status-publish","format-standard","hentry","category-news-en","category-us-agent","category-us-agent-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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