{"id":16491,"date":"2020-11-03T12:30:59","date_gmt":"2020-11-03T11:30:59","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16491"},"modified":"2023-01-24T15:02:01","modified_gmt":"2023-01-24T14:02:01","slug":"latest-fda-strategic-guideline","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/11\/03\/latest-fda-strategic-guideline\/","title":{"rendered":"Latest FDA strategic guideline"},"content":{"rendered":"\n<p>In September 2020 FDA published some \u201c<strong>Final Guidance Document\u201d<\/strong> for companies operating in medical devices field. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/10\/fda-ultime-linee-guida-emesse-1024x536.png\" alt=\"Latest FDA strategic guideline  \" class=\"wp-image-16452\"\/><figcaption>Latest FDA strategic guideline<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Published final version ISO 10993 guideline<\/strong><\/h2>\n\n\n\n<p>On September 4,\n2020 FDA published the <strong>updated guide on the ISO 10993<\/strong> <strong>for the\nbiocompatibility of medical devices<\/strong>. The document which replaces the guide\nfinalized in 2016, specifically addresses to the ISO 10993-1 &#8220;Biological\nevaluation of medical devices &#8211; Part 1: Evaluation and testing within a risk\nmanagement process&#8221;.<\/p>\n\n\n\n<p>This guide is\nuseful for the <strong>Manufacturer <\/strong>as it explains how the standard ISO 10993\nshould be used for biological assessments of medical devices. <\/p>\n\n\n\n<p>Some <strong>key points of the guide<\/strong> are as follows: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Risk assessment to be used in biocompatibility\nassessments;<\/li><li>Use of the ISO 10993-1 together with FDA\nspecific requirements;<\/li><li>General considerations on biocompatibility\ntests;<\/li><li>Considerations on testing for specific areas;<\/li><li>Recommendations for chemical characterisation.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Clinical trial guidelines during COVI<\/strong><strong>D-19<\/strong><strong><\/strong><\/h2>\n\n\n\n<p>On September 21, 2020 FDA published the <strong>\u201cFDA Guidance on Conduct of\nClinical Trials of Medical Products during COVID-19 Public Health Emergency\u201d <\/strong>guide,\nuseful to ensure the <strong>safety of participants<\/strong> in clinical trials of\nmedical products and to answer questions received on the conduct of clinical\ntrials during the <strong>COVID-19 <\/strong>health emergency.<\/p>\n\n\n\n<p>The document draws attention to:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>utmost importance to the safety of participants in clinical trials to determine whether changes in the conduct of studies are necessary;<\/li><li>methods for monitoring the experimentation.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ASCA program<\/strong><\/h2>\n\n\n\n<p>The <strong>ASCA <\/strong>pilot\nprogram (<strong>Accreditation Scheme for Conformity Assessment) <\/strong>allows to <strong>evaluate\nstatements of compliance<\/strong> of medical devices with the standards recognized by the FDA.<\/p>\n\n\n\n<p>On <strong>September 25, 2020 FDA<\/strong> published <strong>3 final guidelines <\/strong>for\nthe ASCA project covering:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The objectives, roles, responsibilities and\nprocedures of the ASCA pilot program; <\/li><li>Basic safety and essential performance of\nelectromedical equipment, electromedical systems and medical laboratory\nequipment;<\/li><li>Indications on how the standards of biological\nevaluation of medical devices are incorporated into the ASCA pilot program.<\/li><\/ul>\n\n\n\n<p>The 3 final guidelines replace the single draft guideline issued by FDA\non September 2019. &nbsp;<\/p>\n\n\n\n<p>Thema constantly monitors updates published by FDA and offers <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consulting services<\/a><\/strong> to companies operating in the medical devices sector.<\/p>\n\n\n\n<p><strong><a href=\"mailto:sales@thema-group.it\">Contact us<\/a><\/strong> to schedule a consultation!<\/p>\n\n\n\n<p><em>Sources:<\/em><\/p>\n\n\n\n<p>\u201cUse of International Standard ISO 10993-1, &#8220;Biological evaluation of medical devices &#8211; Part 1: Evaluation and testing within a risk management process&#8221; \u2013 published on September 4, 2020 &#8211; <a href=\"https:\/\/www.fda.gov\/media\/85865\/download\">https:\/\/www.fda.gov\/media\/85865\/download<\/a> <\/p>\n\n\n\n<p>\u201cFDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency\u201d \u2013 published on September 21, 2020 &#8211; <a href=\"https:\/\/www.fda.gov\/media\/136238\/download\">https:\/\/www.fda.gov\/media\/136238\/download<\/a> <\/p>\n\n\n\n<p>\u201cThe Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program\u201d \u2013 published on September 25, 2020 &#8211; <a href=\"https:\/\/www.fda.gov\/media\/130901\/download\">https:\/\/www.fda.gov\/media\/130901\/download<\/a><\/p>\n\n\n\n<p>\u201cBasic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment &#8211; Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program\u201d \u2013 published on September 25, 2020 &#8211; <a href=\"https:\/\/www.fda.gov\/media\/142385\/download\">https:\/\/www.fda.gov\/media\/142385\/download<\/a> <\/p>\n\n\n\n<p>\u201cBiocompatibility Testing of Medical Devices &#8211; Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program\u201d \u2013 published on September 25, 2020 &#8211; <a href=\"https:\/\/www.fda.gov\/media\/142388\/download\">https:\/\/www.fda.gov\/media\/142388\/download<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>In September 2020 FDA published some \u201cFinal Guidance Document\u201d for companies operating in medical devices field. Published final version ISO 10993  [&#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":[2,1513],"tags":[],"class_list":["post-16491","post","type-post","status-publish","format-standard","hentry","category-news-en","category-us-agent-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Latest FDA strategic guideline<\/title>\n<meta name=\"description\" content=\"In September 2020 FDA published some \u201cFinal Guidance Document\u201d for companies operating in medical devices field.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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