{"id":55329,"date":"2017-12-23T06:33:05","date_gmt":"2017-12-23T06:33:05","guid":{"rendered":"https:\/\/www.biphoo.com\/bipnews\/?p=55329"},"modified":"2017-12-23T06:33:05","modified_gmt":"2017-12-23T06:33:05","slug":"u-s-fda-plans-let-device-makers-report-malfunctions-less-frequently","status":"publish","type":"post","link":"https:\/\/www.biphoo.com\/bipnews\/business\/u-s-fda-plans-let-device-makers-report-malfunctions-less-frequently.html","title":{"rendered":"U.S. FDA plans to let device makers report malfunctions less frequently"},"content":{"rendered":"<h2 style=\"text-align: justify\"><span style=\"font-size: 18pt\"><strong><span style=\"font-family: Arial, Helvetica, sans-serif;color: #000000\">U.S. FDA plans to let device makers report malfunctions less frequently<\/span><\/strong><\/span><\/h2>\n<p style=\"text-align: justify\"><span style=\"font-size: 14pt;font-family: Arial, Helvetica, sans-serif;color: #000000\">U.S. FDA plans to let device makers report malfunctions less frequently:- The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-size: 14pt;font-family: Arial, Helvetica, sans-serif;color: #000000\">The FDA said in a statement that it is proposing to allow the manufacturers to report certain malfunctions in summary reports, rather than having to file individual reports for each malfunction. They would still be required to file individual reports for deaths and serious injuries, the agency said.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-size: 14pt;font-family: Arial, Helvetica, sans-serif;color: #000000\">It has not yet finalized which devices it will allow to file these quarterly reports, but said that new types of medical devices will not be eligible for at least two years.<\/span><\/p>\n<p style=\"text-align: justify\"><span style=\"font-size: 14pt;font-family: Arial, Helvetica, sans-serif;color: #000000\">The regulator is seeking comments about the proposed policy change for 60 days.<\/span><\/p>\n<p><span style=\"font-size: 8pt\">Source:-\u00a0https:\/\/in.reuters.com\/article\/fda-devices\/u-s-fda-plans-to-let-device-makers-report-malfunctions-less-frequently-idINKBN1EG1ZZ<\/span><\/p>\n<div class=\"fb-background-color\">\n\t\t\t  <div \n\t\t\t  \tclass = \"fb-comments\" \n\t\t\t  \tdata-href = \"https:\/\/www.biphoo.com\/bipnews\/business\/u-s-fda-plans-let-device-makers-report-malfunctions-less-frequently.html\"\n\t\t\t  \tdata-numposts = \"10\"\n\t\t\t  \tdata-lazy = \"true\"\n\t\t\t\tdata-colorscheme = \"light\"\n\t\t\t\tdata-order-by = \"social\"\n\t\t\t\tdata-mobile=true>\n\t\t\t  <\/div><\/div>\n\t\t  <style>\n\t\t    .fb-background-color {\n\t\t\t\tbackground: #ffffff !important;\n\t\t\t}\n\t\t\t.fb_iframe_widget_fluid_desktop iframe {\n\t\t\t    width: 630px !important;\n\t\t\t}\n\t\t  <\/style>\n\t\t  ","protected":false},"excerpt":{"rendered":"<p>U.S. FDA plans to let device makers report malfunctions less frequently U.S. FDA plans to let device makers report malfunctions less frequently:- The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":55331,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[111701],"class_list":["post-55329","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business","tag-u-s-fda-plans-to-let-device-makers-report-malfunctions-less-frequently"],"_links":{"self":[{"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/posts\/55329","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/comments?post=55329"}],"version-history":[{"count":0,"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/posts\/55329\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/media\/55331"}],"wp:attachment":[{"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/media?parent=55329"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/categories?post=55329"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.biphoo.com\/bipnews\/wp-json\/wp\/v2\/tags?post=55329"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}