The Food and Drug Administration (FDA) has published guidance dedicated to non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. The document provides additional recommendations to be considered by the...
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published updated guidance on in vitro diagnostic (IVD) medical devices intended for point of care use. The initial version of the...
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules for inspections with regard to medical devices. New...
The Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA), has published detailed information about the Patient Science and Engagement Program – the new approach intended to improve the engagement of patients in...
The National Center for Expertise of Medicines and Medical Devices (NDDA), a country’s body responsible for the assessment of quality and safety of medical devices, has published an official notice describing the newly adopted methodology of expert assessment of the...