{"id":1800,"date":"2020-02-23T14:46:29","date_gmt":"2020-02-23T13:46:29","guid":{"rendered":"https:\/\/www.medsyscon.com\/?p=1800"},"modified":"2021-04-06T16:24:36","modified_gmt":"2021-04-06T14:24:36","slug":"blog-14971-2019","status":"publish","type":"post","link":"https:\/\/www.medsyscon.com\/en\/blog-14971-2019\/","title":{"rendered":"FDA recognizes ISO 14971:2019 as consensus standard"},"content":{"rendered":"\n

Third Edition gets recognized<\/strong><\/a><\/p>\n\n\n\n

On Jan 14, 2020 the US FDA has granted\nRecognized Consensus Standard status to the third edition of the ISO 14971 risk\nmanagement standard for medical devices and IVD products ( see: FDA Recognized Consensus Standards<\/a> ).<\/p>\n\n\n\n

Transition Period<\/strong><\/p>\n\n\n\n

The transition period of the previous standard\nedition, ISO 1497:2007, will last through late 2022. Therefore, any declarations\nof conformity to ISO 14971:2007 included in medical device and IVD premarket\nsubmissions will be accepted by the FDA until December 25, 2022. <\/p>\n\n\n\n

Afterwards a medical device submission requires\na declaration of conformity to the latest edition ISO 14971:2019.<\/p>\n\n\n\n

Please get in touch\nwith 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":"

On Jan 14, 2020 the US FDA has granted Recognized Consensus Standard status to the third edition of the ISO 14971 risk management standard for medical devices and IVD.
\nThe transition period of the previous standard edition, ISO 1497:2007, will last through late 2022. Therefore, any declarations of conformity to ISO 14971:2007 included in medical device and IVD premarket submissions will be accepted by the FDA until December 25, 2022. <\/p>\n","protected":false},"author":5,"featured_media":1801,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[77],"tags":[],"class_list":["post-1800","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-risk-management"],"acf":[],"yoast_head":"\nFDA recognizes ISO 14971:2019 as consensus standard - 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-14971-2019\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA recognizes ISO 14971:2019 as consensus standard - MedSysCon Medizintechnik GmbH\" \/>\n<meta property=\"og:description\" content=\"On Jan 14, 2020 the US FDA has granted Recognized Consensus Standard status to the third edition of the ISO 14971 risk management standard for medical devices and IVD. The transition period of the previous standard edition, ISO 1497:2007, will last through late 2022. 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