1.0MedSysCon Medizintechnik GmbHhttps://www.medsyscon.com/en/adminhttps://www.medsyscon.com/en/author/admin/FDA recognizes ISO 14971:2019 as consensus standard - MedSysCon Medizintechnik GmbHrich600338<blockquote class="wp-embedded-content" data-secret="oOfz5eWoah"><a href="https://www.medsyscon.com/en/blog-14971-2019/">FDA recognizes ISO 14971:2019 as consensus standard</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.medsyscon.com/en/blog-14971-2019/embed/#?secret=oOfz5eWoah" width="600" height="338" title="“FDA recognizes ISO 14971:2019 as consensus standard” — MedSysCon Medizintechnik GmbH" data-secret="oOfz5eWoah" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script>
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https://www.medsyscon.com/wp-content/uploads/2020/02/Final-Picture-700x435-5.jpg700435On 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. 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.