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US FDA Roundup: Final De Novo Rule, GUDID for Class I Medical Devices, Reclassification of Surgical Staples
US regulators have issued final rules for de novo novel device classification requests and up-classification of surgical staplers, as well as updated GUDID submission requirements for some class I devices. Learn more at Emergo by UL.
US FDA Rolls Out List of Registered Medical Devices Featuring Artificial Intelligence and Machine Learning
FDA regulators have published a searchable list of medical devices incorporating artificial intelligence and machine learning (AI/ML) to promote transparency. Learn more about US FDA regulations at Emergo by UL.
Australia TGA to Accept CE Mark Conformity Assessments for Some High-Risk Medical Devices, IVDs
The therapeutic goods administration (TGA) will accept conformity assessments from European notified bodies for some Class III medical devices, active implantable devices and Class 4 IVDs submitted for registration in Australia. Learn more at Emergo by UL