COVID-19
The Food and Drug Administration (FDA) issued updated guidance dedicated to tests intended to be used in the context of the outbreak of COVID-19. Due to the importance of the highlighted issues, the guidance is subject to immediate implementation without public...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical devices, announced the reduction of annual charges for medical devices listed on the prostheses list. Prostheses Medical Devices: Regulatory Background According...
COVID-19
The Food and Drug Administration (FDA) issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden reduction systems. The document describes special extraordinary measures...
Australia and Oceania
In relation to difficulties associated with the Coronavirus or COVID-19, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain...
COVID-19
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices, issued guidance dedicated to formal meetings and user fee applications for medical devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19)...
COVID-19
The Food and Drug Administration (FDA or the Agency) issued detailed guidelines dedicated to adverse event reporting rules for medical devices placed on the market under the Emergency Use Authorization (EUA). The EUA is a special regulatory framework implemented by...
