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
Crafting Effective Use Scenario Prompts: A Key to Medical Device Usability Test Success
Our Human Factors Research & Design team provides recommendations for developing appropriate and effective use scenario prompts to support more accurate medical device, IVD and combination product usability test results.
Singapore HSA Finalizes Unique Device Identification (UDI) Requirements for Medical Devices
Singapore's health sciences authority (HSA) has issued final guidance on unique device identification (UDI) rules for medical devices and IVDs, with a phased implementation timeline for compliance. Learn more at Emergo by UL.
Chinese Regulators Revise Drug-Device Combination Product Registration Requirements
Chinese regulators have updated marketing application requirements for makers of combination products featuring pharmaceutical and medical device components. Learn more about NMPA regulations for combination products, medical devices and IVDs.
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