27. August 2018 Will ISO 13485:2016 be used by the FDA? A notice published by ISO indicates that the FDA may be considering to replace the Current Quality System requirements (as published under 21CFR820) by the ISO 13485 already in 2019. This would create a further step to the global harmonization.... tagPlaceholderTags: medical device, USA, ISO 13485, 21CFR820