The compliance date for unique device identifier requirements for Class I and unclassified medical devices has been extended by the FDA from Sept. 24, 2018, to Sept. 24, 2020, and for direct mark requirements from Sept. 24, 2020, to Sept. 24, 2022. The extensions were made in response to industry concerns about meeting compliance dates, as well as to resolve issues regarding higher-risk devices before lower-risk devices are added to the UDI system.
Sign up for AdvaMed SmartBrief
Medical technology news
Get the intelligence you need: news and information
that is changing your industry today, hand-curated by our professional editors from
thousands of sources and delivered straight to your inbox.