{"id":1812,"date":"2020-03-12T11:12:07","date_gmt":"2020-03-12T10:12:07","guid":{"rendered":"https:\/\/www.medsyscon.com\/?p=1812"},"modified":"2021-04-06T16:12:03","modified_gmt":"2021-04-06T14:12:03","slug":"blog-fda-postpone","status":"publish","type":"post","link":"https:\/\/www.medsyscon.com\/en\/blog-fda-postpone\/","title":{"rendered":"FDA postpones foreign medical device inspections due to COVID-19 concerns"},"content":{"rendered":"\n

The U.S. Food and Drug Administration is postponing inspections outside of the U.S. in response to the COVID-19 outbreak. The FDA is postponing most foreign inspections through April 2020, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For medical device manufacturers based outside the US which are dependent on FDA inspections to obtain US market registration, this announcement may mean delays in premarket application reviews. <\/p>\n\n\n\n

FDA states\nthat although temporarily not being able to physically inspect foreign produced\nFDA-regulated products or manufacturers, as an interim measure FDA will employ additional\ntools to ensure the safety of products imported to the U.S., which have proved\neffective in the past. These include denying entry of unsafe products into the\nU.S., physical examinations and\/or product sampling at our borders, reviewing a\nfirm\u2019s previous compliance history, using information sharing from foreign\ngovernments as part of mutual recognition and confidentiality agreements and\nrequesting records \u201cin advance of or in lieu of\u201d on-site drug inspections. For\nexample, FDA began exercising this authority when postponing on-the-ground\ninspections of manufacturers of FDA-regulated products in China earlier in the\noutbreak. This is all part of the FDA\u2019s multi-pronged and risk-based approach\nto ensuring quality, as well as compliance, with applicable federal laws and\nregulations.<\/p>\n\n\n\n

As this\nremains a dynamic situation, FDA will continue to assess and calibrate their\napproach as needed to help advance federal response efforts in the fight\nagainst this outbreak.<\/p>\n\n\n\n

Please read the full FDA statement here<\/strong><\/a> <\/p>\n\n\n\n

<\/p>\n\n\n\n

\"\"
Andrii Vodolazhskyi\/shutterstock.com <\/figcaption><\/figure>\n\n\n\n

Please get in touch with us for any further support:<\/p>\n\n\n\n

www.medsyscon.com\/en<\/a> <\/p>\n\n\n\n

info@medsyscon.com<\/a><\/p>\n\n\n\n

+49-176-57694801<\/p>\n\n\n\n

\"\"<\/figure>\n","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration is postponing inspections outside of the U.S. in response to the COVID-19 outbreak. The FDA is postponing most foreign inspections through April 2020, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For medical device manufacturers based outside the US which are dependent on FDA inspections to obtain \u2026<\/p>\n","protected":false},"author":5,"featured_media":1813,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[83],"tags":[],"class_list":["post-1812","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-general"],"acf":[],"yoast_head":"\nFDA postpones foreign medical device inspections due to COVID-19 concerns - MedSysCon Medizintechnik GmbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.medsyscon.com\/en\/blog-fda-postpone\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA postpones foreign medical device inspections due to COVID-19 concerns - MedSysCon Medizintechnik GmbH\" \/>\n<meta property=\"og:description\" content=\"The U.S. Food and Drug Administration is postponing inspections outside of the U.S. in response to the COVID-19 outbreak. 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