Tag: Europe Regulatory News

Medical Devices – USA/Europe Regulatory News – Dec. 2023

Medical Device

USA FDA Guidance on Assessing Credibility of Computational Modeling and Simulation The FDA has issued guidance detailing a nine-step framework to assess the credibility of computational modeling...

Clinical Trial, Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – Nov 2023

Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled medical devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-September 2023

Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators,...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance

Medical Devices-USA/Europe Regulatory News – August 2023

Medical Device

USA(FDA) Medical Device User Fee Rates for Fiscal Year 2024 The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees...

Europe Regulatory News, Harmonised standards, Medical Devices, Regulatory News, Software as a Medical Device (SaMD), USA Regulatory News

Medical Devices-USA/Europe Regulatory News-July 2023

Medical Device

USA(FDA) Content of Premarket Submissions for Device Software Functions The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software...

Europe Regulatory News, FDA, HPRA, Medical Devices, MHRA, Premarket Approval (PMA), Regulatory News, USA Regulatory News