{"id":13724,"date":"2020-03-06T15:32:02","date_gmt":"2020-03-06T14:32:02","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=13724"},"modified":"2023-01-24T15:02:04","modified_gmt":"2023-01-24T14:02:04","slug":"usa-fda-regulatory-agenda-for-2020","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/03\/06\/usa-fda-regulatory-agenda-for-2020\/","title":{"rendered":"USA: FDA\u2019s Regulatory Agenda for 2020"},"content":{"rendered":"\n<p>Last November 2019 the Food and Drug Administration (FDA) published the regulatory activities\nplanned for 2020. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/03\/planner-1.png\" alt=\"Food and Drug Administration (FDA) regulatory agenda for 2020.\" class=\"wp-image-13728\"\/><\/figure>\n\n\n\n<p>In <strong>January 2020<\/strong> FDA wished to attribute to the Class III the<strong> <\/strong><em><strong>spinal spheres<\/strong> <\/em>to use in the intervertebral merging procedures and the minimally manipulated allograft heart valves (MMM), unless approval from the market. Nevertheless FDA has established that the general and special regulatory controls, defined until now, are not sufficient to provide a reasonable safety and efficacy guarantee for these devices that, for now, remain excluded by Class III.<\/p>\n\n\n\n<p>In<strong> February 2020<\/strong> the publication of the regulation related to the<strong> <\/strong><em><strong>Clinical Hold<\/strong><\/em><strong> <\/strong>(clinical suspension of medical devices investigations) was planned.<strong> <\/strong><\/p>\n\n\n\n<p>By <strong>April 2020<\/strong> medical device quality system regulation will be renewed. FDA\u2019s review will replace the existing requirements with the specifics of the standard <strong>&nbsp;ISO<\/strong> <strong>13485:2016<\/strong>, with the intention to reduce the compliance and registration charges to the manufacturers, harmonizing the International and American requirements.<\/p>\n\n\n\n<p>By <strong>May 2020<\/strong> changes to the&nbsp;\u201cMedical Device Software Regulations\u201d are provided. The Regulations will be reviewed to be made consistent to the \u201c21st Century Cures Act\u201d, which involves the <strong>exclusion of some softwares (with certain characteristics) from the category of medical devices<\/strong>.<\/p>\n\n\n\n<p>By <strong>June 2020<\/strong> FDA wants to finalize two of its current proposals: &nbsp;the first regulation will apply the <strong>restrictions on products for solar lamps, including lamps<\/strong> with ultraviolet rays (UV)), sunbeds and tanning boohts; the second regulation will establish formal procedures and criteria for<em> <\/em><strong><em>de novo<\/em> classification process<\/strong>, so to make it more transparent for the manufacturers that use it in the device marketing process.<\/p>\n\n\n\n<p><strong>Sources :<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/www.reginfo.gov\/public\/do\/eAgendaMain\">https:\/\/www.reginfo.gov\/public\/do\/eAgendaMain<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last November 2019 the Food and Drug Administration (FDA) published the regulatory activities planned for 2020. In January 2020 FDA wished  [&#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-13724","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>USA: FDA\u2019s Regulatory Agenda for 2020<\/title>\n<meta name=\"description\" content=\"The Food and Drug Administration (FDA) published the regulatory activities planned for 2020. See the Regulatory&#039;s actions planned month by month.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.thema-med.com\/en\/2020\/03\/06\/usa-fda-regulatory-agenda-for-2020\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USA: FDA\u2019s Regulatory Agenda for 2020\" \/>\n<meta property=\"og:description\" content=\"The Food and Drug Administration (FDA) published the regulatory activities planned for 2020. 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