{"id":5648531,"date":"2020-09-19T17:38:07","date_gmt":"2020-09-19T20:38:07","guid":{"rendered":"https:\/\/igaviascience.com\/?p=5648531"},"modified":"2021-06-07T19:48:45","modified_gmt":"2021-06-07T22:48:45","slug":"pre-cert-update-us-fda-lays-out-next-steps-for-samd-certification-program","status":"publish","type":"post","link":"https:\/\/igaviascience.com\/es\/pre-cert-update-us-fda-lays-out-next-steps-for-samd-certification-program\/","title":{"rendered":"Pre-Cert Update: US FDA lays out next steps for SaMD certification program"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">2020, Sep<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The US Food and Drug Administration has issued a new report on progress as well as next steps for its ongoing pilot program to develop a new certification framework for Software as a Medical Device (SaMD).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u2019s updates on the agency\u2019s <\/span><b>Software Precertification (Pre-Cert) Program<\/b><span style=\"font-weight: 400;\"> summarizes key findings from the program\u2019s pilot phase, as well as the implications of these findings for further development efforts:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">\u201cMock\u201d Excellence Appraisals of SaMD products based on remote work as well as objective evidence may effectively substitute for on-site visits;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The program\u2019s Streamlined Review component for qualifying SaMD requires additional examination and testing;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Collecting and examining real-world performance data enables observation of measures including human factors engineering and usability, safety and risk management, but further testing is required to support assessing health benefits using such data.<\/span><\/li>\n<\/ul>\n<h2><em><strong>What comes next for Pre-Cert development<\/strong><\/em><\/h2>\n<p><span style=\"font-weight: 400;\">Following FDA\u2019s testing activities carried out with participating companies including Apple, FitBit, Roche, Johnson &amp; Johnson and Samsung, the regulator plans additional iterative and revised testing approaches for the Pre-Cert program.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Among these next steps are utilizing a draft library of key performance indicators (KPIs) to further develop and test \u201cexcellence thresholds\u201d for Pre-Cert program participants, as well as establish test scenarios for least-burdensome methods for setting safe and effective total product lifecycle processes for SaMD products.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Regarding the Streamlined Review framework whereby Pre-Cert participants obtain expedited US market access, FDA plans further analysis of data collected via Excellence Appraisals, premarket review determinations and real-world performance monitoring to establish relevant criteria.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In general, FDA is now shifting efforts toward integration of key Pre-Cert program components including Excellence Appraisals, review determinations, Streamlined Review and real-world performance as well as developing a deeper understanding of how these components function as whole.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In addition, the 2020 Update summarizes the FDA\u2019s test activities, provides an update on our progress, shares what we have learned, and outlines next steps. For more information, <\/span><span style=\"font-weight: 400;\">see <\/span><a href=\"https:\/\/www.fda.gov\/media\/142107\/download\"><span style=\"font-weight: 400;\">Developing the Software Precertification Program: Summary of Learnings and Ongoing Activities: 2020 Update<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For additional US FDA medical device and SaMD regulatory resources, please <\/span><span style=\"font-weight: 400;\">contact us<\/span><span style=\"font-weight: 400;\"> for more information on our medical device consulting services<\/span><\/p>\n<p><a href=\"https:\/\/fdaregistrationinusa.wordpress.com\/\" target=\"_blank\" rel=\"noopener\">Practical Guide for FDA Registration<\/a><\/p>\n<p><a class=\"buttonBlog\" href=\"https:\/\/igaviascience.com\/es\/contact\/\" target=\"_blank\" rel=\"noopener\">Questions? Request more information from our specialist. Contact us \u21e2\u21e2<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>2020, Sep The US Food and Drug Administration has issued a new report on&#8230;<\/p>","protected":false},"author":1,"featured_media":5648533,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mi_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[22],"tags":[],"class_list":["post-5648531","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda-news"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/posts\/5648531","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/comments?post=5648531"}],"version-history":[{"count":12,"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/posts\/5648531\/revisions"}],"predecessor-version":[{"id":5648643,"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/posts\/5648531\/revisions\/5648643"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/media\/5648533"}],"wp:attachment":[{"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/media?parent=5648531"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/categories?post=5648531"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/igaviascience.com\/es\/wp-json\/wp\/v2\/tags?post=5648531"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}