COVID-19
The Food and Drug Administration (FDA or the Agency), a US authority responsible for medical device regulation, issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden...
Australia and Oceania
In relation to difficulties associated with the coronavirus, 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 regulatory changes in...
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...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical devices regulation, issued guidelines describing how medical device manufacturers shall apply for inclusion of the COVID-19 test in the national register of medicinal products...
The World Health Organization (WHO), the international organization focused on public health protection, issued a notice providing medical device manufacturers and industry representatives additional information that addresses COVID-19-related issues. The document...
