{"id":17960,"date":"2021-04-27T09:21:47","date_gmt":"2021-04-27T07:21:47","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=17960"},"modified":"2023-12-12T16:07:55","modified_gmt":"2023-12-12T15:07:55","slug":"usa-cdrh-announces-new-biocompatibility-assessment-resource-center","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/04\/27\/usa-cdrh-announces-new-biocompatibility-assessment-resource-center\/","title":{"rendered":"USA: CDRH announces new Biocompatibility Assessment Resource Center"},"content":{"rendered":"\r\n<p>Last month, the Food and Drug Administration\u2019s (FDA) <strong>Center for Devices and Radiological Health (CDRH)<\/strong> announced the <strong>new electronic Biocompatibility Assessment Resource Center<\/strong>. The website is intended to provide guidance for evaluating the <strong>biocompatibility of Medical Devices <\/strong>in order to manage more easily the ISO 10993-1 requirements.<\/p>\r\n\r\n\r\n\r\n<p>This resource aligns with the recommendations established in Use of International Standard ISO 10993-1, \u201cBiological evaluation of medical devices \u2013 Part 1: Evaluation and testing within a risk management process\u201d published in September 2020 by the FDA.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-17910\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/04\/usa-centro-risorse-valutazione-biocompatibilita-1024x536.png\" alt=\"USA CDRH announces new Biocompatibility Assessment Resource Center\" \/>\r\n<figcaption>CDRH announces new Biocompatibility Assessment Resource Center<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Guide for Biocompatibility Evaluation<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>These resource pages are <strong>intended to explain<\/strong> terms and concepts important for the evaluation of biocompatibility of Medical Devices.<\/p>\r\n\r\n\r\n\r\n<p>The information contained in the website is not intended to replace any policies specified in ISO 10993-1 standard or the FDA guidance. It rather aims <strong>to help Medical Devices Manufacturers<\/strong> select the most appropriate tests to evaluate the adverse biological responses to Medical Devices.<\/p>\r\n\r\n\r\n\r\n<p>This guidance outlines <strong>four steps<\/strong> for device Manufacturers to follow:<\/p>\r\n\r\n\r\n\r\n<ol class=\"wp-block-list\">\r\n<li><strong>\u201cBiocompatibility Basics\u201d<\/strong>, that provides <strong>basic information on biocompatibility<\/strong> and <strong>a glossary<\/strong> of biocompatibility terms.\r\n<p>&nbsp;<\/p>\r\n<\/li>\r\n<li><strong>\u201cEvaluation Endpoints\u201d, <\/strong>that supplies biocompatibility evaluation endpoint <strong>tables<\/strong> by device category.\r\n<p>&nbsp;<\/p>\r\n<\/li>\r\n<li><strong>\u201cTest Articles\u201d, <\/strong>that provides <strong>examples of documenting test article comparisons to proposed devices<\/strong>.\r\n<p>&nbsp;<\/p>\r\n<\/li>\r\n<li><strong>\u201cTest Report\u201d, <\/strong>which includes the recommended contents of a test report<strong>.<\/strong><\/li>\r\n<\/ol>\r\n\r\n\r\n\r\n<p>FDA recommends the use of the <strong>Q-Submission program<\/strong> to submit specific question on biocompatibility evaluation.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>How can Thema help you?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Through our wide range of <a href=\"https:\/\/www.thema-med.com\/en\/services\/\">strategic regulatory consulting services<\/a>, our team of experts is available to provide you with further information and support during the phase of biological safety evaluation of devices.<\/p>\r\n\r\n\r\n\r\n<p>Please contact us sending an e-mail to <a href=\"mailto:sales@thema-group.it\"><strong>sales@thema-group.it<\/strong><\/a><\/p>\r\n\r\n\r\n\r\n<p><em>Source:<\/em><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/biocompatibility-assessment-resource-center\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Biocompatibility Assessment Resource Center FDA<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Last month, the Food and Drug Administration\u2019s (FDA) Center for Devices and Radiological Health (CDRH) announced the new electronic Biocompatibility Assessment  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23083,"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],"tags":[1568],"class_list":["post-17960","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-usa-topic"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CDRH announces 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